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EFSA Journal 2014;12(1):3524

CONCLUSION ON PESTICIDE PEER REVIEW

Conclusion on the peer review of the pesticide risk assessment of the active
substance Straight Chain Lepidopteran Pheromones1
European Food Safety Authority2

European Food Safety Authority (EFSA), Parma, Italy

ABSTRACT
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk
assessments carried out by the competent authority of the rapporteur Member State Austria, for the pesticide
active substance Straight Chain Lepidopteran Pheromones are reported. The context of the peer review was that
required by Commission Regulation (EC) No 2229/2004 as amended by Commission Regulation (EC) No
1095/2007. The conclusions were reached on the basis of the evaluation of the representative uses of Straight
Chain Lepidopteran Pheromones as a semio-chemical on stone fruit, pome fruit, tree nuts corn, vegetables,
citrus, olives, rice, grapes, cotton and flowers. The reliable endpoints concluded as being appropriate for use in
regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are
presented. Missing information identified as being required by the regulatory framework is listed.There is no
agreed technical specification covered by the toxicological and ecotoxicological assessments.

© European Food Safety Authority, 2014

KEY WORDS
Straight Chain Lepidopteran Pheromones, peer review, risk assessment, pesticide, semio-chemicals

1
On request from the European Commission, Question No EFSA-Q-2009-00294, approved on 13 December 2013.
2
Correspondence: pesticides.peerreview@efsa.europa.eu

Suggested citation: European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment of
the active substance Straight Chain Lepidopteran Pheromones. EFSA Journal 2014;12(1):3524. 537 pp.
doi:10.2903/j.efsa.2014.3524
Available online: www.efsa.europa.eu/efsajournal

© European Food Safety Authority, 2014


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

SUMMARY
Straight Chain Lepidopteran Pheromones is one of the 295 substances of the fourth stage of the review
programme covered by Commission Regulation (EC) No 2229/2004, as amended by Commission
Regulation (EC) No 1095/2007.

Straight Chain Lepidopteran Pheromones was included in Annex I to Directive 91/414/EEC on 18


December 2008 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to
as „the Regulation‟) and has subsequently been deemed to be approved under Regulation (EC) No
1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended
by Commission Implementing Regulation (EU) No 541/2011. In accordance with Article 25a of the
Regulation, as amended by Commission Regulation (EU) No 114/2010, the European Food Safety
Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report
submitted by the European Commission in accordance with Article 25(1) of the Regulation. This
review report was established as a result of the initial evaluation provided by the designated rapporteur
Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of
the DAR. The conclusions of the peer review are set out in this report.

Austria being the designated rapporteur Member State submitted the DAR on Straight Chain
Lepidopteran Pheromones in accordance with the provisions of Article 22(1) of the Regulation, which
was received by the EFSA on 2 April 2008. The peer review was initiated on 9 September 2011 by
dispatching the DAR for consultation of the Member States and the notifier International Bio-rationale
Manufacturing Association as the leader of the task force. Following consideration of the comments
received on the DAR, it was concluded that EFSA should conduct a focused peer review in the area of
mammalian toxicology and deliver its conclusions on Straight Chain Lepidopteran Pheromones.

The conclusions laid down in this report were reached on the basis of the evaluation of the
representative uses of Straight Chain Lepidopteran Pheromones as an semio-chemical on stone fruit,
pome fruit, tree nuts corn, vegetables, citrus, olives, rice, grapes, cotton and flowersas proposed by the
notifiers. Full details of the representative uses can be found in Appendix A to this report.

In the area of identity, physical/chemical/technical properties and methods of analysis numerous data
gaps were identified for all active substances.

In the mammalian toxicology section, data gaps were identified for the the identification of non-SCLP
impurities in the individual technical specifications and assessment of their toxicological relevance,
for the genotoxic potential of the SCLP aldehyde group, for the operator, worker and bystander
exposure to the spraying of microencapsulated vapour releasing system. Operator, worker and
bystander exposure risk assessment (to both application methods proposed) could not be finalised due
to a further data gap on the establishment of more reliable natural background levels.

In the residue section, the consumer risk assessment could not be finalised because of the data gaps
identified.

The information available on environmental fate and behaviour was insufficient to carry out the
necessary environmental exposure assessments or conclude that using products as proposed, would not
result in natural background levels being exceeded. This was because reliable observations or
measurements of natural background levels were not provided. This resulted in the conclusion that the
necessary assessments could not be finalised.

Data gaps were identified for suitable risk assessments for non-target organism (birds, mammals,
aquatic organisms, honey bees, non-target arthropods, earthworms, soil micro-organisms and non-
target plants). A low risk to sewage treatment organisms was concluded.

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TABLE OF CONTENTS
Abstract .................................................................................................................................................... 1
Summary .................................................................................................................................................. 2
Table of contents ...................................................................................................................................... 3
Background .............................................................................................................................................. 4
The active substance and the formulated product .................................................................................... 6
Conclusions of the evaluation .................................................................................................................. 6
1. Identity, physical/chemical/technical properties and methods of analysis ...................................... 6
2. Mammalian toxicity ......................................................................................................................... 6
3. Residues ........................................................................................................................................... 8
4. Environmental fate and behaviour ................................................................................................... 8
5. Ecotoxicology .................................................................................................................................. 9
6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment
of effects data for the environmental compartments .............................................................................. 10
6.1. Soil ........................................................................................................................................ 10
6.2. Ground water ........................................................................................................................ 11
6.3. Surface water and sediment .................................................................................................. 14
6.4. Air ......................................................................................................................................... 16
7. List of studies to be generated, still ongoing or available but not peer reviewed .......................... 18
8. Particular conditions proposed to be taken into account to manage the risk(s) identified............. 19
9. Concerns ........................................................................................................................................ 20
9.1. Issues that could not be finalised .......................................................................................... 20
9.2. Critical areas of concern ....................................................................................................... 20
9.3. Overview of the concerns identified for each representative use considered ....................... 20
References .............................................................................................................................................. 24
Appendices ............................................................................................................................................. 26
Abbreviations ....................................................................................................................................... 534

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BACKGROUND
Straight Chain Lepidopteran Pheromones is one of the 295 substances of the fourth stage of the review
programme covered by Commission Regulation (EC) No 2229/2004,3 as amended by Commission
Regulation (EC) No 1095/2007.4

Straight Chain Lepidopteran Pheromones was included in Annex I to Directive 91/414/EEC5 on 18


December 2008 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to
as „the Regulation‟) and has subsequently been deemed to be approved under Regulation (EC) No
1107/2009,6 in accordance with Commission Implementing Regulation (EU) No 540/2011,7 as
amended by Commission Implementing Regulation (EU) No 541/2011.8 In accordance with Article
25a of the Regulation, as amended by Commission Regulation (EU) No 114/20109 the European Food
Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review
report submitted by the European Commission in accordance with Article 25(1) of the Regulation
(European Commission, 2008). This review report was established as a result of the initial evaluation
provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The
EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in
this report.

Austrai being the designated rapporteur Member State submitted the DAR on Straight Chain
Lepidopteran Pheromones in accordance with the provisions of Article 22(1) of the Regulation, which
was received by the EFSA on 2 April 2008 (Austria, 2008). The peer review was initiated on 9
September 2011 by dispatching the DAR to Member States and the notifier International Bio-rationale
Manufacturing Association as the leader of the task force for consultation and comments. In addition,
the EFSA conducted a public consultation on the DAR. The comments received were collated by the
EFSA and forwarded to the RMS for compilation and evaluation in the format of a Reporting Table.
The notifier was invited to respond to the comments in column 3 of the Reporting Table. The
comments were evaluated by the RMS in column 3 of the Reporting Table.

The scope of the peer review was considered in a telephone conference between the EFSA, the RMS,
and the European Commission on 25 June 2012. On the basis of the comments received and the
RMS‟ evaluation thereof it was concluded that the EFSA should organise a consultation with Member
State experts in the area of mammalian toxicology.

The outcome of the telephone conference, together with EFSA‟s further consideration of the
comments is reflected in the conclusions set out in column 4 of the Reporting Table. All points that
were identified as unresolved at the end of the comment evaluation phase and which required further
3
Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the
implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC.
OJ L 379, 24.12.2004, p.13-63.
4
Commission Regulation (EC) No 1095/2007 of 20 September 2007 amending Regulation (EC) No 1490/2002 laying down
further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC and Regulation (EC) No 2229/2004 laying down further detailed rules for the
implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC.
OJ L 246, 21.9.2007, p.19-28.
5
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L
230, 19.8.1991, p. 1-32, as last amended.
6
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing
of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309,
24.11.2009, p.1-50.
7
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009
of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p.1-
186.
8
Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No
540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list
of approved active substances. OJ L 153, 11.6.2011, p.187-188.
9
Commission Regulation (EU) No 114/2010 of 9 February 2010 amending Regulation (EC) No 2229/2004 as regards the
time period granted to EFSA for the delivery of its view on the draft review reports concerning the active substances for
which there are clear indications that they do not have any harmful effects. OJ L 37, 10.2.2010, p.12.

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consideration, including those issues to be considered in consultation with Member State experts, and
additional information to be submitted by the notifier, were compiled by the EFSA in the format of an
Evaluation Table.

The conclusions arising from the consideration by the EFSA, and as appropriate by the RMS, of the
points identified in the Evaluation Table, together with the outcome of the expert discussions where
these took place, were reported in the final column of the Evaluation Table.

A final consultation on the conclusions arising from the peer review of the risk assessment took place
with Member States via a written procedure in October/November 2013.

This conclusion report summarises the outcome of the peer review of the risk assessment on the active
substance and the representative formulation evaluated on the basis of the representative uses as a
insecrticide on stone fruit as proposed by the notifier. A list of the relevant end points for the active
substance as well as the formulation is provided in Appendix A. In addition, a key supporting
document to this conclusion is the Peer Review Report, which is a compilation of the documentation
developed to evaluate and address all issues raised in the peer review, from the initial commenting
phase to the conclusion. The Peer Review Report (EFSA, 2013) comprises the following documents,
in which all views expressed during the course of the peer review, including minority views, can be
found:

• the comments received on the DAR,

• the Reporting Tables (25 June 2012)

• the Evaluation Tables (<<DD Month YYYY>>),

• the report(s) of the scientific consultation with Member State experts (where relevant),

• the comments received on the assessment of the points of clarification (where relevant),

• the comments received on the draft EFSA conclusion.

Given the importance of the DAR including its addendum (compiled version of October 2013
containing all individually submitted addenda (Austria, 2013)) and the Peer Review Report, both
documents are considered respectively as background documents A and B to this conclusion.

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THE ACTIVE SUBSTANCE AND THE FORMULATED PRODUCT


None of the straight chain lepidopteran pheromones (SCLPs)10 have ISO common names. A full set of
IUPAC names can be found in the tables in section 6.

The representative formulated products for the evaluation were „Isomate C LR‟ containing (E,E)-8,10-
dodecadien-1-ol, 1-tetradecanol, 1-dodecanol, (Z)-9-tetradecen-1-yl acetate, (Z)-11-tetradecen-1-yl
acetate and „Checkmate CM-F‟ containing (E,E)-8,10-dodecadien-1-ol. For the other active substances
not contained in these formulations no formulation data were provided.

The representative uses for „Isomate C LR‟ comprise applications in dispensers in pome fruit, stone
fruit and tree nuts, and for „Checkmate CM-F‟ spray applications on pome fruit, stone fruit and tree
nuts. Full details of the GAPs can be found in the list of end points in Appendix A.

In the list of end points there are also other formulations and GAP tables, but none of these
formulations have been supported in the dossier and a data gap has been set. Also „Isomate C LR‟
contains the active substance 1-dodecanol, information for which was not presented in the dossier or
DAR, so a data gap has been identified.

CONCLUSIONS OF THE EVALUATION

1. Identity, physical/chemical/technical properties and methods of analysis


The following guidance documents were followed in the production of this conclusion:
SANCO/3030/99 rev.4 (European Commission, 2000), Sanco/10597/2003 – rev. 8.1 (European
Commission, 2009), and SANCO/825/00 rev. 7 (European Commission, 2004a).

The minimum purity for the BAS source of compound No. 5 is 87%, however the specification is not
finalised as there are methods issues and also the levels of some impurities are not accepted. For all
the other active substances no specifications have been accepted and for this a general data gap is
identified for a full set of data with regard to the method of manufacture, starting materials,
specifications, batch analysis and supporting analytical data.

For all active substances it could not be concluded if the physical-chemical properties of the active
substances were acceptable and what possible extrapolations could be made. A data gap is identified
and this issue remains open.

For the formulation „Isomate C LR‟ data gaps were identified for flammability and shelf life. For the
formulation „Checkmate CM-F‟ data gaps were identified for accelerated storage, shelf life and low
temperature stability.

Fully validated methods of analysis were not available for the formulations or technical materials and
a data gap is identified.

No methods were available for plants or the environment and a data gap is identified. Methods of
analysis for body fluids and tissues are not required as the active substances are not classified as toxic
or very toxic.

2. Mammalian toxicity
The following guidance documents were followed in the production of this conclusion:
SANCO/221/2000 rev. 10 - final (European Commission, 2003), SANCO/222/2000 rev. 7 (European
Commission, 2004b) and SANCO/10597/2003 – rev. 8.1 (European Commission, 2009).

10
The definition for SCLPs given in the OECD GD (2001) p.11, see list of references.

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SCLPs were discussed at the Pesticides Peer Review Meeting 95 in September 2012.

The impurity profile of the batches used in the toxicological studies is not available and a data gap was
identified for the identification of non-SCLP impurities in the individual technical specifications and
assessment of their toxicological relevance (see section 7).

SCLPs are naturally occurring substances produced by insects in the order Lepidoptera, including
butterflies and moths. Waiving of toxicological data has been proposed based on the non-toxic,
targeted mode of action, their typically low rates of application expected to result in a low human
exposure and their low toxicological concern. However, this rationale is applicable when long term
exposure above background level can be excluded (OECD, 2001).

Acute toxicity (by the oral, dermal and inhalation routes) and in vitro genotoxicity studies were
provided on a number of SCLP substances and mixtures. It was agreed that bridging of studies within
a chemical group, i.e, within acetate, alcohol and aldehyde SCLPs was appropriate. SCLPs presented
low acute toxicity, by the oral, dermal or inhalation routes, except for the aldehyde group that was
found to be harmful by inhalation. Apart from the aldehydes group and isolated substances that were
properly tested, all SCLPs were proposed for classification as skin irritant. No potential for eye
irritation was observed, except for one blend mixture of (E)-5-decen-1-yl acetate and (E)-5-decen-1-ol
(no. 30). Potential for skin sensitisation was observed in the alcohol group and should be attributed
also to the aldehyde group based on their chemical structure.

A 28-day oral toxicity study conducted with (E,E)-8,10-dodecadien-1-ol (no. 18) was provided. The
study was performed as a limit dose test at 1000 mg/kg bw per day dose level. This dose level was
considered a NOAEL for females, and a LOAEL for males based on erosions of the glandular mucosa
of the stomach and tubular dilatation or vacuolation in the kidneys.

No genotoxic potential was observed in vitro in bacterial and mammalian cells gene mutation assays
and chromosome aberration test covering the acetate and alcohol groups, as no genotoxicity study was
presented on any aldehyde, a data gap was identified to address the genotoxic potential of aldehydes
(see section 7).

Waiving of further repeated dose studies, long term, reproductive and developmental studies,
including the setting of reference values was suggested based on low level of human exposure, not
exceeding the natural background level concentrations.

Two types of application were proposed: through a vapour releasing closed dispenser or spraying a
microencapsulated vapour releasing system. For the closed dispenser system, it was agreed that
exposure would essentially occur by inhalation and therefore could be compared to natural
background levels. However, it was concluded in the environmental fate section that the concentration
levels indicated by the applicant could not be independently verified (see chapter 4) and therefore, a
data gap was identified to present a range of robust natural background levels to assess operator,
worker and bystander exposure. This issue was therefore identified as a data gap (see section 7) and
assessment not finalised (see section 9.1).

Regarding application through spraying of microencapsulated vapour releasing system, dermal


exposure would also have to be considered besides the inhalation route. A comparison with natural
background level may also be possible, however, further to the robust natural background level
referred above, a realistic exposure assessment for operators, workers and bystanders is required and a
data gap was set on this issue. This issue was therefore identified as a further data gap (see section 7)
and assessment not finalised (see section 9.1).

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3. Residues
The assessment in the residue section below is based on the guidance documents listed in the
document 1607/VI/97 rev.2 (European Commission, 1999), and the JMPR recommendations on
livestock burden calculations stated in the 2004 and 2007 JMPR reports.

For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers on human and livestock edible crops, the natural concentration levels were not reported in
the DAR. The applicant refers to the OECD Guidance (2002) for pheromones that states that the
concentration of SCLPs in the environment after the use of SCLPs as a plant protection product
remains within the range of the concentrations released from target pests during naturally occurring
infestation periods. EFSA was unable to verify whether the reported concentrations were underpinned
by reliable field measurements. A data gap is set to address the natural background levels of SCLPs
based on field measurements and to demonstrate that the use of SCLPs as a plant protection product
according to the use pattern for the formulations emitted via volatilisation from closed retrievable
dispensers will result in concentrations not exceeding the naturally occurring SCLPs levels in the
environment.

For the low volume spray application of microencapsulated SCLPs, no specific studies to evaluate the
residues in plants upon the use of SCLPs as a plant protection product were submitted in the DAR. A
data gap was therefore identified to provide a sufficient residue data package in order to conduct a
reliable consumer dietary risk assessment.

4. Environmental fate and behaviour


The acetates group of SCLPs have vapour pressures reported in the range 0.00008 to 6.93 Pa at 20°C.
The alcohol and aldehyde group have vapour pressures reported in the range 0.0008 to 1.364Pa at 20-
25°C. The reported range of vapour pressures of the individual components in the blends group are in
the range 0.00008 to 1.364Pa at 20°C. Consequently these pheromone compounds fall into the classes
of medium volatility to volatile, with most being volatile (FOCUS, 2008). It should be noted however
(see section 1) that there is a data gap related to physical-chemical properties that includes vapour
pressures. For the compounds (E,E)-8,10-dodecadien-1-ol; (Z)-11-tetradecen-1-yl acetate and (Z)-9-
dodecen-1-yl acetate satisfactory information was provided to indicate that these compounds would
not be subject to long range atmospheric transport due to their calculated short atmospheric half lives
(calculated for the process of indirect photochemical oxidative degradation) of 2.75 to 5.6 hours, being
less than 2 days (FOCUS, 2008). Information in this respect was not provided for any of the other
compounds being assessed. This issue was therefore identified as a data gap (see section 7) and
assessment not finalised (see section 9.1).

The applicants dossier was prepared following OECD (2001) guidance for pheromones and other
semiochemicals that suggests that an application threshold of up to 375 g SCLPs ha-1 yr-1 is considered
appropriate to reflect the natural concentration levels of SCLPs. However observations or
measurements of natural concentrations were not included in the applicants dossier. Also the reference
in the OECD (2001) guidance is to a personal communication and not articles from the published peer
reviewed scientific literature. Consequently it is impossible to independently verify whether the
application threshold that originates from the OECD (2001) guidance is underpinned by the reliable
observations / measurements that are the usual evidence needed in the EU regulatory framework for
plant protection products. This issue was therefore identified as a data gap (see section 7) and
assessment not finalised (see section 9.1).

The RMS assessment (Austria, 2013) indicated that for spray application of microencapsulated SCLPs
(as opposed to products where the compounds are emitted via volatilisation from passive dispensers) it
could not be precluded that the use of these products would result in natural background levels (as
defined by the threshold of up to 375 g SCLPs ha-1 yr-1) in soil, or natural surface waters adjacent to
treated areas, being exceeded. As amounts that would be deposited in soil might in addition also have
the potential to leach to groundwater, the RMS also concluded that groundwater exposure would need

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to be considered. These issues were therefore identified as data gaps (see section 7) and is covered by
the first point indicating assessment not finalised (see section 9.1).

For the dispenser applications, the indications of high vapour pressure for the different pheromones,
are considered sufficient to conclude that groundwater exposure by them is unlikely.

5. Ecotoxicology
Ecotoxicity data were not available for all groups of non-target organisms for each active substance. It
was agreed to extrapolate ecotoxicity data within each chemical class of straight chain lepidopteran
pheromones (SCLPs). Where no data were available for the chemical class, it was proposed to use the
lowest available toxicity endpoint from other chemical class of SCLPs. However, no scientific
reasoning was provided to support this proposal and therefore, pending the outcome of the exposure
assessment (see below), further information may be required to support the extrapolation of
ecotoxicity data between the different chemical classes.

As discussed in section 1, no technical specifications are available, therefore a data gap was identified
to demonstrate that the test material of the batches used in the ecotoxicity studies are suitably
representative of the technical specification.

No risk assessments were available for the representative uses of SCLPs as a foliar spray. Therefore,
data gaps were identified to address the risk to non-target organisms (birds, wild mammals, aquatic
organisms, honey bees, earthworms, soil micro-organisms and non-target plants).

The ecotoxicological risk assessments for the representative uses of SCLPs in passive dispersers was
based on the OECD (2001) guidance for pheromones and other semiochemicals that suggests that an
application threshold of up to 375 g SCLPs ha-1 yr-1 is considered appropriate to reflect the natural
concentration levels of SCLPs. It was proposed that the representative use of SCLPs in passive
dispensers will not lead to greater exposure than the natural background level which would therefore
allow a low risk to non-target organisms to be concluded. However, as discussed in detail in section 4,
it was not possible to independently validate this value with observations / measurements from
scientific literature and therefore the value was not considered suitable for the exposure assessment.
Consequently, a data gap was identified for further information to support the argumentation that the
representative use of SCLPs in passive dispensers will not lead to greater environmental exposure than
the natural background levels (see section 4). Although, it is acknowledged that the available
ecotoxicity data do not indicate high toxicity to non-target organisms, it was not possible to finalise
the risk assessment due to the exposure assessment data gap.

The representative uses of SCLPs are unlikely to lead to exposure of sewage treatment organisms and
therefore a low risk was concluded (relevant for all representative uses).

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6. Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental
compartments

6.1 Soil
Compound name
(dossier code for the pheromone and or pheromone Persistence Ecotoxicology
mixture in which it is included)

Case made when application is via dispense that Case made when application is via dispense that
exposure will be within natural background levels exposure will be within natural background levels
(quoted as 375 g SCLP/ha/year), but data gaps (quoted as 375 g SCLP/ha/year), but data gaps
(E)-5-decen-1-yl acetate (No. 1, in 30) identified, as the way natural background levels have identified, as the way natural background levels have
been elucidated needs to be explained and the been elucidated needs to be explained and the
measurements used as the basis for elucidation have not measurements used as the basis for elucidation have not
been reported. For spray application data gap. been reported. For spray application data gap.

(E)-8-dodecen-1-yl acetate (No. 2 in 31) As above. As above.

(Z)-8-dodecen-1-yl acetate (No. 4, in 25 and 31) As above. As above.

(Z)-9-dodecen-1-yl acetate (No. 5, in 26) As above. As above.

(E,Z)-7,9-dodecadien-1-yl acetate (No. 6, in 27) As above. As above.

(E)-11-tetradecen-1-yl acetate (No. 7) As above. As above.

(Z)-9-tetradecen-1-yl acetate (No. 8) As above. As above.

(Z)-11-tetradecen-1-yl acetate (No. 9) As above. As above.

(Z, E)-9, 12-tetradecadien-1-yl acetate (No. 10) As above. As above.

(Z)-11-hexadecen-1-yl acetate (No. 11, in 32) As above. As above.

(Z, E)-7, 11-hexadecadien-1-yl acetate (No. 13, in 28) As above. As above.

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(E, Z)-2, 13-octadecadien-1-yl acetate (No. 14) As above. As above.

(E)-5-decen-1-ol (No. 16, in 30) As above. As above.

(Z)-8-dodecen-1-ol (No. 17 in 31) As above. As above.

(E,E)-8,10-dodecadien-1-ol (No. 18) As above. As above.

tetradecan-1-ol (No. 19) As above. As above.

(Z)-11-hexadecen-1-ol (No. 20) As above. As above.

(Z)-7-tetradecenal (No. 21) As above. As above.

(Z)-9-hexadecenal (No. 22, in 29) As above. As above.

(Z)-11-hexadecenal (No. 23 in 29 & 32) As above. As above.

(Z)-13-octadecenal (No. 24, in 29) As above. As above.

dodecyl acetate (in 25 & 26) As above. As above.

(E,E)-7,9-dodecadien-1-yl acetate (in 27) As above. As above.

(Z,Z)-7,11-hexadecadien-1-yl acetate (in 28) As above. As above.

(E/Z)-8-dodecen-1-yl acetate (No. 3 in 31) As above. As above.

6.2 Ground water


>0.1 μg/L 1m depth for
Compound the representative uses
Mobility in soil (at least one FOCUS Pesticidal activity Toxicological relevance Ecotoxicological activity
(name and/or code)
scenario or relevant
lysimeter)(a)

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Lepidopteran Pheromones

Data not available, but


vapour pressure
considered to indicate that No dispenser application, Data gap for surface water
(E)-5-decen-1-yl acetate Yes Yes
leaching to groundwater is data gap spray application risk assessment.
unlikely for dispenser
products

No dispenser application, Data gap for surface water


(E)-8-dodecen-1-yl acetate As above. Yes Yes
data gap spray application risk assessment.

No dispenser application, Data gap for surface water


(Z)-8-dodecen-1-yl acetate As above. Yes Yes
data gap spray application risk assessment.

Data gap for surface water


(Z)-9-dodecen-1-yl acetate As above. No Yes Yes
risk assessment.

(E,Z)-7,9-dodecadien-1-yl Data gap for surface water


As above. No Yes Yes
acetate risk assessment.

(E)-11-tetradecen-1-yl Data gap for surface water


As above. No Yes Yes
acetate risk assessment.

(Z)-9-tetradecen-1-yl Data gap for surface water


As above. No Yes Yes
acetate risk assessment.

(Z)-11-tetradecen-1-yl Data gap for surface water


As above. No Yes Yes
acetate risk assessment.

(Z,E)-9, 12-tetradecadien- Data gap for surface water


As above. No Yes Yes
1-yl acetate risk assessment.

(Z)-11-hexadecen-1-yl No dispenser application, Data gap for surface water


As above. Yes Yes
acetate data gap spray application risk assessment.

(Z,E)-7, 11-hexadecadien- Data gap for surface water


As above. No Yes Yes
1-yl acetate risk assessment.

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(E,Z)-2, 13-octadecadien- Data gap for surface water


As above. No Yes Yes
1-yl acetate risk assessment.

No dispenser application, Data gap for surface water


(E)-5-decen-1-ol As above. Yes Yes
data gap spray application risk assessment.

No dispenser application, Data gap for surface water


(Z)-8-dodecen-1-ol As above. Yes Yes
data gap spray application risk assessment.

(E,E)-8,10-dodecadien-1- No dispenser application, Data gap for surface water


As above. Yes Yes
ol data gap spray application risk assessment.

Data gap for surface water


tetradecan-1-ol As above. No Yes Yes
risk assessment.

Data gap for surface water


(Z)-11-hexadecen-1-ol As above. No Yes Yes
risk assessment.

Data gap for surface water


(Z)-7-tetradecenal As above. No Yes Yes
risk assessment.

Data gap for surface water


(Z)-9-hexadecenal As above. No Yes Yes
risk assessment.

No dispenser application, Data gap for surface water


(Z)-11-hexadecenal As above. Yes Yes
data gap spray application risk assessment.

Data gap for surface water


(Z)-13-octadecenal As above. No Yes Yes
risk assessment.

Data gap for surface water


dodecyl acetate As above. No Yes Yes
risk assessment.

(E,E)-7,9-dodecadien-1-yl Data gap for surface water


As above. No Yes Yes
acetate risk assessment.

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Lepidopteran Pheromones

(Z,Z)-7,11-hexadecadien- No dispenser application, Data gap for surface water


As above. Yes Yes
1-yl acetate data gap spray application risk assessment.

(E/Z)-8-dodecen-1-yl Data gap for surface water


As above. No Yes Yes
acetate risk assessment.

(a): EFSA‟s reading of Directive 98/83/EC11 is, that as these active substances are mating disrupters or attractants for mass trapping they are not considered pesticides under this directive, so the
parametric drinking water limit of 0.1µg/L for pesticides, that has been used as a decision making criteria under Directive 91/414/EEC regarding groundwater exposure, would not apply.
However it is of note that Directive 2006/118/EC12, that is the decision making criteria under Regulation (EC) No 1107/2009 regarding groundwater exposure, would consider these active
substances are pesticides, so the parametric drinking water limit of 0.1µg/L for pesticides would apply.

6.3 Surface water and sediment


Compound
Ecotoxicology
(name and/or code)

Case made when application is via dispense that exposure will be within natural background levels (quoted as 375
g SCLP/ha/year), but data gaps identified, as the way natural background levels have been elucidated needs to be
(E)-5-decen-1-yl acetate
explained and the measurements used as the basis for elucidation have not been reported. For spray application
data gap.

(E)-8-dodecen-1-yl acetate As above.

(Z)-8-dodecen-1-yl acetate As above.

(Z)-9-dodecen-1-yl acetate As above.

(E,Z)-7,9-dodecadien-1-yl acetate As above.

(E)-11-tetradecen-1-yl acetate As above.

(Z)-9-tetradecen-1-yl acetate As above.

11
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. OJ L 350, 5.12.1998, p. 32-54.
12
Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration. OJ L 372, 27.12.2006, p. 19-
31.

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(Z)-11-tetradecen-1-yl acetate As above.

(Z,E)-9, 12-tetradecadien-1-yl acetate As above.

(Z)-11-hexadecen-1-yl acetate As above.

(Z,E)-7, 11-hexadecadien-1-yl acetate As above.

(E,Z)-2, 13-octadecadien-1-yl acetate As above.

(E)-5-decen-1-ol As above.

(Z)-8-dodecen-1-ol As above.

(E,E)-8,10-dodecadien-1-ol As above.

tetradecan-1-ol As above.

(Z)-11-hexadecen-1-ol As above.

(Z)-7-tetradecenal As above.

(Z)-9-hexadecenal As above.

(Z)-11-hexadecenal As above.

(Z)-13-octadecenal As above.

dodecyl acetate As above.

(E,E)-7,9-dodecadien-1-yl acetate As above.

(Z,Z)-7,11-hexadecadien-1-yl acetate As above.

(E/Z)-8-dodecen-1-yl acetate As above.

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6.4 Air
Compound
Toxicology
(name and/or code)

(E)-5-decen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E)-8-dodecen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-8-dodecen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-9-dodecen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E,Z)-7,9-dodecadien-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E)-11-tetradecen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-9-tetradecen-1-yl acetate Rat LC50 inhalation > 5.29 mg/L air/4-hour (whole body); no classification required

(Z)-11-tetradecen-1-yl acetate Rat LC50 inhalation > 5.3 mg/L air/4-hour (whole body); no classification required

(Z,E)-9, 12-tetradecadien-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-11-hexadecen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-13-hexadecen-11-yn-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z,E)-7, 11-hexadecadien-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E,Z)-2, 13-octadecadien-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z,Z,Z,Z)-7,13,16,19-docosatetraen-1-yl isobutyrate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E)-5-decen-1-ol Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-8-dodecen-1-ol Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

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(E,E)-8,10-dodecadien-1-ol Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

tetradecan-1-ol Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z)-11-hexadecen-1-ol Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

Rat LC50 inhalation > 4.46 (females), 4.82 (males and sex combined) mg/L air/4-hour (whole body); R20 ‘harmful
(Z)-7-tetradecenal
by inhalation’

Rat LC50 inhalation > 4.46 (females), 4.82 (males and sex combined) mg/L air/4-hour (whole body); R20 ‘harmful
(Z)-9-hexadecenal
by inhalation’

Rat LC50 inhalation > 4.46 (females), 4.82 (males and sex combined) mg/L air/4-hour (whole body); R20 ‘harmful
(Z)-11-hexadecenal
by inhalation’

Rat LC50 inhalation > 4.46 (females), 4.82 (males and sex combined) mg/L air/4-hour (whole body); R20 ‘harmful
(Z)-13-octadecenal
by inhalation’

dodecyl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E,E)-7,9-dodecadien-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(Z,Z)-7,11-hexadecadien-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

(E/Z)-8-dodecen-1-yl acetate Rat LC50 inhalation > 5 mg/L air/4-hour (whole body); no classification required

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7. List of studies to be generated, still ongoing or available but not peer reviewed
This is a complete list of the data gaps identified during the peer review process, including those areas
where a study may have been made available during the peer review process but not considered for
procedural reasons (without prejudice to the provisions of Article 7 of Directive 91/414/EEC
concerning information on potentially harmful effects).

Complete set of data in all areas of the risk assessment for 1-dodecanol (relevant for 1-dodecanol;
submission date proposed by the notifier: unknown; see section 1)

For the SCLPs that are not contained in the formulations „Isomate C LR‟ or „Checkmate CM-F‟ a
full formulation data package is required (relevant for the active substances not present in the
named formulations; submission date proposed by the notifier: unknown; see section 1)

For the BASF source of (Z)-9-dodecen-1-yl acetate the notifier should explain the peak of another
octadecan at a retention time of approx. 6 min., the specifications for impurities 1 and 3 should be
reconsidered. (relevant for the BASF source of (Z)-9-dodecen-1-yl acetate; submission date
proposed by the notifier: unknown; see section 1)

For all sources other than BASF source of (Z)-9-dodecen-1-yl acetate a full set of data with regard
to method of manufacture, starting materials, specifications, batch analysis and supporting
analytical data (relevant for all sources other than BASF source of (Z)-9-dodecen-1-yl acetate;
submission date proposed by the notifier: unknown; see section 1)

For each physical and chemical property of all the SCLPs they should be put together and it
should be justified on the basis of structure what possible extrapolations can be made (relevant for
all representative uses evaluated ; submission date proposed by the notifier: unknown; see section
1)

For „Isomate C LR‟ data on flammability and shelf life (relevant for all representative uses of this
formulation; submission date proposed by the notifier: unknown; see section 1)

For „Checkmate CM-F‟ data on accelerated storage, shelf life and low temperature stability
(relevant for all representative uses of this formulation; submission date proposed by the notifier:
unknown; see section 1)

Fully validated methods of analysis for all formulations and technical materials (relevant for all
representative uses evaluated ; submission date proposed by the notifier: unknown; see section 1)

Methods of analysis for residues on/in plants and environmental matrices (relevant for all
representative uses evaluated; submission date proposed by the notifier: unknown; see section 1)

Identification of non-SCLP impurities in the individual technical specifications and assessment of


their toxicological relevance (relevant for all representative uses evaluated; submission date
proposed by the notifier: unknown; see section 2)

The genotoxic potential of aldehyde SCLPs has not been addressed (relevant for aldehyde SCLPs
representative uses evaluated; submission date proposed by the notifier: unknown; see section 2)

Assessment of operator, worker and bystander exposure levels to the spraying of


microencapsulated vapour releasing system (relevant for the microencapsulated vapour releasing
system uses evaluated; submission date proposed by the notifier: unknown; see section 2

The experimental observations and measurements that underpin the OECD trigger dose of 375 g
SCLP/ha/year (OECD guidance, ENV/JM/MONO(2001)12) as representing natural background

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levels, that may be encountered when there is a high level lepidopteran infestation, were not
available to the Member State peer review organised by EFSA (relevant for all representative uses
evaluated, submission date proposed by the notifier: unknown; see section 2, 3, 4 and 5).

Data gap to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern where
the compounds are emitted via volatilisation from passive dispensers will result in concentrations
not exceeding the naturally occurring SCLPs levels in the environment (relevant for the
representative uses evaluated where application is via volatilisation from passive dispensers;
submission date proposed by the notifier: unknown; see section 3)

A sufficient residue data package is required for the low volume spray application of
microencapsulated SCLPs formulation (relevant for the representative use evaluated where
application is via low volume spray application of microencapsulated SCLPs; submission date
proposed by the notifier: unknown; see section 3)

The information available in the applicants dossier is insufficient to conclude on predicted


environmental concentrations (PEC) in soil, surface water and sediment and groundwater after
spray application of microencapsulated SCLPs. An exceedence of natural background levels of
SCLPs can not be excluded in these compartments following spray application (relevant for
representative uses evaluated where application is by spraying; submission date proposed by the
notifier: unknown; see section 4)

The information available in the applicants dossier is insufficient to conclude on the potential for
long range atmospheric transport via air after spray application of microencapsulated SCLPs that
may form aerosols at the time of spraying. Data (measurements) demonstrating that microcapsules
have a particle size range that would exclude long range transport (ie. > 80 µm) or information on
the atmospheric half life of the products would be 2 options for addressing this. (relevant for
representative uses evaluated where application is by spraying; submission date proposed by the
notifier: unknown; see section 4)

Atkinson half life calculations for indirect photolysis (for indirect photochemical oxidative
degradation) to give estimates of atmospheric half lives for each SCLP assessed except (E,E)-
8,10-dodecadien-1-ol; (Z)-11-tetradecen-1-yl acetate and (Z)-9-dodecen-1-yl acetate were not
available. (relevant for all representative uses except for products that exclusively contain these
three substances; submission date proposed by the notifier: unknown; see section 4)

Pending the outcome of the exposure assessment, risk assessments for birds, mammals, aquatic
organisms, honey bees, non-target arthropods, earthworms, soil micro-organism and non-target
plants (relevant for all representative uses evaluated; submission date proposed by the notifier:
unknown; see section 5).

Information to demonstrate that the test material of the batches used in the ecotoxicity studies are
suitably representative of the technical specification (relevant for all representative uses evaluated;
submission date proposed by the notifier: unknown; see section 5).

8. Particular conditions proposed to be taken into account to manage the risk(s) identified
None proposed.

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9. Concerns
9.1 Issues that could not be finalised
An issue is listed as an issue that could not be finalised where there is not enough information
available to perform an assessment, even at the lowest tier level, for the representative uses in line
with the Uniform Principles of Annex VI to Directive 91/414/EEC and where the issue is of such
importance that it could, when finalised, become a concern (which would also be listed as a critical
area of concern if it is of relevance to all representative uses).

1. As it has not been demonstrated that the trigger dose of 375 g SCLP/ha/year (originating from
OECD (2001) guidance) is underpinned by robust observations or measurements, the operator,
worker, bystander, environmental exposure and risk assessments were not finalised.
Consequently risk assessments in these sectors could not be finalised.

2. For operators, workers and bystanders exposed to the sprayed microencapsulated vapour
releasing system products, further to robust background exposure, their level of exposure by
inhalation and skin contact needs to be addressed.

3. The consumer dietary risk assessment could not be finalised.

4. The potential for long range transport through the atmosphere of the substances assessed except
(E,E)-8,10-dodecadien-1-ol; (Z)-11-tetradecen-1-yl acetate and (Z)-9-dodecen-1-yl acetate could
not be finalised.

9.2 Critical areas of concern


An issue is listed as a critical area of concern where there is enough information available to perform
an assessment for the representative uses in line with the Uniform Principles of Annex VI to Directive
91/414/EEC, and where this assessment does not permit to conclude that for at least one of the
representative uses it may be expected that a plant protection product containing the active substance
will not have any harmful effect on human or animal health or on groundwater or any unacceptable
influence on the environment.

An issue is also listed as a critical area of concern where the assessment at a higher tier level could not
be finalised due to a lack of information, and where the assessment performed at the lower tier level
does not permit to conclude that for at least one of the representative uses it may be expected that a
plant protection product containing the active substance will not have any harmful effect on human or
animal health or on groundwater or any unacceptable influence on the environment.

There is no agreed technical specification covered by the toxicological and ecotoxicological


assessments.

9.3 Overview of the concerns identified for each representative use considered
(If a particular condition proposed to be taken into account to manage an identified risk, as listed in
section 8, has been evaluated as being effective, then „risk identified‟ is not indicated in this table.)
All columns are grey as there is no agreed technical material specification, no impurity profile of the
material used in the testing studies, which are proposed to be compared to natural background levels
and the potential for long range transport was not finalised except for (E,E)-8,10-dodecadien-1-ol; (Z)-
11-tetradecen-1-yl acetate and (Z)-9-dodecen-1-yl acetate.

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Dispenser
in pome
Spray in
fruit, Dispenser
pome
stone Dispenser in maize,
fruit, Spray in
Representative use fruit, in grapes lucern,
stone fruit grapes
citrus, and olives rice and
and tree
banana cotton
nuts
and tree
nuts

Risk
identified
Operator risk
Assessment
not finalised
X1 X1, 2 X1 X1, 2 X1
Risk
identified
Worker risk
Assessment
not finalised
X1 X1, 2 X1 X1, 2 X1
Risk
identified
Bystander risk
Assessment
not finalised
X1 X1, 2 X1 X1, 2 X1
Risk
identified
Consumer risk
Assessment
not finalised
X3 X3 X3 X3 X3
Risk
Risk to wild non identified
target terrestrial
Assessment
vertebrates not finalised
X1 X1 X1 X1 X1
Risk to wild non Risk
target terrestrial identified
organisms other Assessment
not finalised
X1 X1 X1 X1 X1
than vertebrates
Risk
Risk to aquatic identified
organisms Assessment
not finalised
X1 X1 X1 X1 X1
Legal
parametric
Groundwater value
exposure active breached
substance Assessment
not finalised
X X
Legal
parametric
value
breached
Groundwater
Parametric
exposure value of
metabolites 10µg/L(a)
breached
Assessment
not finalised
Comments/Remarks

The superscript numbers in this table relate to the numbered points indicated in sections 9.1 and 9.2. Where there is no
superscript number see sections 2 to 6 for further information.
(a): Value for non-relevant metabolites prescribed in SANCO/221/2000-rev 10-final, European Commission, 2003.

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Spray in
vegetables
Dispenser
including
in
leafy,
vegetables Spray in
Spray in brassica, Dispenser in spray in
Representative use including sugar
cotton stem, root ornamentals ornamentals
garlic and beet
and tuber
fruiting
and
vegetables
fruiting
vegetables

Risk
identified
Operator risk
Assessment
not finalised
X1, 2 X1 X1, 2 X1, 2 X1 X1, 2
Risk
identified
Worker risk
Assessment
not finalised
X1, 2 X1 X1, 2 X1, 2 X1 X1, 2
Risk
identified
Bystander risk
Assessment
not finalised
X1, 2 X1 X1, 2 X1, 2 X1 X1, 2
Risk
identified
Consumer risk
Assessment
not finalised
X3 X3 X3 X3 N/A N/A
Risk to wild Risk
non target identified
terrestrial Assessment
not finalised
X1 X1 X1 X1 X1 X1
vertebrates
Risk to wild Risk
non target identified
terrestrial
organisms Assessment
not finalised
X1 X1 X1 X1 X1 X1
other than
vertebrates
Risk
Risk to aquatic identified
organisms Assessment
not finalised
X1 X1 X1 X1 X1 X1
Legal
parametric
Groundwater value
exposure active breached
substance Assessment
not finalised
X X X X
Legal
parametric
value
breached
Groundwater
Parametric
exposure value of
metabolites 10µg/L(a)
breached
Assessment
not finalised
Comments/Remarks

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The superscript numbers in this table relate to the numbered points indicated in sections 9.1 and 9.2. Where there is no
superscript number see sections 2 to 6 for further information.
(a): Value for non-relevant metabolites prescribed in SANCO/221/2000-rev 10-final, European Commission, 2003.
N/A: Not applicable

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REFERENCES
Austria, 2008. Draft Assessment Report (DAR) on the active substance Straight Chain Lepidopteran
Pheromonesprepared by the rapporteur Member State Austria in the framework of Directive
91/414/EEC, Month YYYY.
Austria, 2013. Final Addendum to Draft Assessment Report on Straight Chain Lepidopteran
Pheromones, compiled by EFSA, October 2013.
EFSA (European Food Safety Authority), 2009. Guidance Document on Risk Assessment for Birds
and Mammals on request of EFSA. EFSA Journal 2009;7(12):1438, 358 pp.
doi:10.2903/j.efsa.2009.1438
EFSA (European Food Safety Authority), 2013. Peer Review Report to the conclusion regarding the
peer review of the pesticide risk assessment of the active substance Straight Chain Lepidopteran
Pheromones. Available online: www.efsa.europa.eu
European Commission, 1999. Guidelines for the generation of data concerning residues as provided in
Annex II part A, section 6 and Annex III, part A, section 8 of Directive 91/414/EEC concerning the
placing of plant protection products on the market, 1607/VI/97 rev.2, 10 June 1999.
European Commission, 2000. Technical Material and Preparations: Guidance for generating and
reporting methods of analysis in support of pre- and post-registration data requirements for Annex
II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414. SANCO/3030/99
rev.4, 11 July 2000.
European Commission, 2001. Guidelines on comparability, extrapolation, group tolerances and data
requirements for setting MRLs. SANCO Doc 7525/VI/95-rev.7. pp.1-31.
European Commission, 2002a. Guidance Document on Terrestrial Ecotoxicology Under Council
Directive 91/414/EEC. SANCO/10329/2002 rev.2 final, 17 October 2002.
European Commission, 2002b. Guidance Document on Aquatic Ecotoxicology Under Council
Directive 91/414/EEC. SANCO/3268/2001 rev 4 (final), 17 October 2002.
European Commission, 2002c. Guidance Document on Risk Assessment for Birds and Mammals
Under Council Directive 91/414/EEC. SANCO/4145/2000.
European Commission, 2003. Guidance Document on Assessment of the Relevance of Metabolites in
Groundwater of Substances Regulated under Council Directive 91/414/EEC. SANCO/221/2000-
rev. 10 - final, 25 February 2003.
European Commission, 2004a. Guidance document on residue analytical methods. SANCO/825/00
rev. 7, 17 March 2004.
European Commission, 2004b. Guidance Document on Dermal Absorption. SANCO/222/2000 rev. 7,
19 March 2004.
European Commission, 2009. Guidance Document on the Assessment of the Equivalence of Technical
Materials of Substances Regulated under Council Directive 91/414/EEC. SANCO/10597/2003 –
rev. 8.1, May 2009.
European Commission, 2012. Review Report for the active substance Straight Chain Lepidopteran
Pheromones finalised in the Standing Committee on the Food Chain and Animal Health at its
meeting on 20November 2011 in view of the inclusion of Straight Chain Lepidopteran
Pheromones. in Annex I of Directive 91/414/EEC, SANCO/2633/08 – rev. 5 , 20 November 2012.
FOCUS, 2008. “Pesticides in Air: Considerations for Exposure Assessment”. Report of the FOCUS
Working Group on Pesticides in Air, EC Document Reference SANCO/10553/2006 Rev 2 June
2008.

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JMPR (Joint Meeting on Pesticide Residues), 2004. Report of the Joint Meeting of the FAO Panel of
Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group
on Pesticide Residues Rome, Italy, 20–29 September 2004, Report 2004, 383 pp.
JMPR (Joint Meeting on Pesticide Residues), 2007. Report of the Joint Meeting of the FAO Panel of
Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group
on Pesticide Residues Geneva, Switzerland, 18–27 September 2007, Report 2007, 164 pp.
OECD (Organisation for Economic Co-operation and Development), 2001. Guidance for registration
requirements for pheromones and other semiochemicals used for arthropod pest control.
ENV/JM/MONO(2001)32, 26 February 2002.
SETAC (Society of Environmental Toxicology and Chemistry), 2001. Guidance Document on
Regulatory Testing and Risk Assessment procedures for Plant Protection Products with Non-Target
Arthropods. ESCORT 2.

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APPENDICES
APPENDIX A – LIST OF END POINTS FOR THE ACTIVE SUBSTANCE AND THE REPRESENTATIVE
FORMULATION

General comment: Where appropriate, the lists of endpoints were modified according to the format for
the listing of endpoints proposed in appendix 9 of the OECD Series on Pesticides (Number 12):
Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for
Arthropod Pest Control ENV/JM/MONO(2001)12.

25 Acetate Blend: (Z)-8-Dodecenyl Acetate; Dodecan-1-yl Acetate


Listing of end points
Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ No ISO common name


Function (e.g. fungicide) Semio-chemicals

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)


Chemical name (IUPAC) ‡ i) (Z)-8-dodecen-1-yl acetate
ii) Dodecyl acetate
Chemical name (CA) ‡ i) (Z)-8-dodecen-1-ol acetate
ii) Dodecyl acetate
CIPAC No ‡ i) 861
ii) 884

CAS No ‡ i) 28079-04-1
ii) 112-66-3
EC No (EINECS or ELINCS) ‡ i) 248-823-6
ii) 203-995-1
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C14H26O2
ii) C14H28O2

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Lepidopteran Pheromones

Molecular mass ‡ i) 226.359 g/mol


ii) 228.375 g/mol
Structural formula ‡ i)
O

O CH3

ii)
OAc

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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Z8-12:Ac 97.7% purity
12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
242-249°C
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Z8-12:Ac 97.7% purity
12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Yellow liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state Z8-12:Ac 97.7% purity
purity) ‡ 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)

20°C
Z8-12Ac = 0.157 Pa
12:Ac = 0.094 Pa

25°C
Z8-12Ac = 0.245 Pa
12:Ac = 0.162 Pa
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state Z8-12:Ac 97.7% purity
purity and pH) ‡ 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Z8-12:Ac (20°C)
Day 1 = 7.1 x 10-4 g/l (RSD 21.2%)
Day 2 = 8.0 x 10-4 g/l (RSD 6.8%)
Day 3 = 7.1 x 10-4 g/l (RSD 2.5%)
12:Ac (20°C)
Day 1 = 9 x 10-5 g/l (RSD 21.8%)
Day 2 = 13 x 10-4 g/l (RSD 1.5%)
Day 3 = 13 x 10-4 g/l (RSD 10.4%)
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Solubility in organic solvents ‡ Z8-12:Ac 97.7% purity


(state temperature, state purity) 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Totally soluble in organic solvents. No precipitate
was generated
Open for applicability of data to all the SCLP‘s
Surface tension ‡ Z8-12:Ac 97.7% purity
(state concentration and temperature, state 12:Ac 98.9% purity
purity)
(Blend mix ratio 50.2:49.2)
39.9mN/m
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ Z8-12:Ac 97.7% purity
(state temperature, pH and purity) 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Z8-12:Ac
log P = 5.61 (25°C)
12:Ac
log P = 6.25 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
UV/VIS absorption (max.) incl. ‡ Z8-12:Ac 97.7% purity
(state purity, pH) 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
UV VIS
52.88486486 cm-1 mol-1 l (204nm)
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Z8-12:Ac 97.7% purity
12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Flash point: 126°C
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

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Summary of representative uses evaluated (Acetate Blend: (Z)-8-Dodecenyl Acetate; Dodecan-1-yl Acetate)
Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Plum Italy ECODIAN® F Grapholita VP 20mg/ 2000- Before the 1st 2/3 60 days n. a. n. a. 2000- n. a.
And other (DPR CF / Isagro funebrana dispen 2500- generation/fli 2500-
Stone 290) ser 3000 ght of the 3000
Fruits dispenser moth dispense
s/ha (low- rs/ha x
mod-high 20mg =
density 40g-50g-
pest) 60g/ha

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
: use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (Z)-8-dodecen-1-yl acetate
(animals and plants) ii) Dodecyl acetate
Toxicologically relevant compounds ‡ i) (Z)-8-dodecen-1-yl acetate
(environment) ii) Dodecyl acetate

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

(E/Z)-8-dodecen-1-yl acetate, (Z)-9-


dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP)

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

No reliable range of naturally occuring backgound


levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
13
RMS/peer review proposal
Substance classified: acetate blend: (Z)-8- Xi ―Irritant‖
dodecen-1-yl acetate and Dodecyl acetate R38 ―Irritating to skin‖

13
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)

Open.

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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (Z)-8-dodecen-1-yl acetate


ii) Dodecyl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 2000 mg/kg bw (based on lowest endpoint of
SCLPs Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Acetate Blend: (Z)-8-
96 hr No data
Fish Dodecenyl Acetate; LC50
provided
Dodecan-1-yl Acetate
Acetate Blend: (Z)-8-
Aquatic invertebrates 48 hr No data
Dodecenyl Acetate; EC50
(flow-through) provided
Dodecan-1-yl Acetate
Acetate Blend: (Z)-8-
72 hr EbC50 No data
Algae Dodecenyl Acetate;
(static) ErC50 provided
Dodecan-1-yl Acetate
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)

EFSA Journal 2014;12(1):3524 39


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Lepidopteran Pheromones

Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil i) (Z)-8-dodecen-1-yl acetate
ii) Dodecyl acetate
water i) (Z)-8-dodecen-1-yl acetate
ii) Dodecyl acetate

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

sediment i) (Z)-8-dodecen-1-yl acetate


ii) Dodecyl acetate
groundwater i) (Z)-8-dodecen-1-yl acetate
ii) Dodecyl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

26 Acetate Blend: (Z)-9-Dodecenyl Acetate; Dodecan-1-yl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (Z)-9-dodecen-1-yl acetate


ii) Dodecyl acetate
Chemical name (CA) ‡ i) (Z)-9-dodecen-1-ol acetate
ii) Dodecyl acetate
CIPAC No ‡ i) 422
ii) 884
CAS No ‡ i) 16974-11-1
ii) 112-66-3
EC No (EINECS or ELINCS) ‡ i) 241-054-7
ii) 203-995-1
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C14H26O2
ii) C14H28O2
Molecular mass ‡ i) 226.359 g/mol
ii) 228.375 g/mol
Structural formula ‡ i)
O

O CH3

ii)
OAc

EFSA Journal 2014;12(1):3524 42


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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Z8-12:Ac 97.7% purity
12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
242-249°C
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Z8-12:Ac 97.7% purity
12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Yellow liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state Z8-12:Ac 97.7% purity
purity) ‡ 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)

20°C
Z8-12Ac = 0.157 Pa
12:Ac = 0.094 Pa

25°C
Z8-12Ac = 0.245 Pa
12:Ac = 0.162 Pa
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state Z8-12:Ac 97.7% purity
purity and pH) ‡ 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Z8-12:Ac (20°C)
Day 1 = 7.1 x 10-4 g/l (RSD 21.2%)
Day 2 = 8.0 x 10-4 g/l (RSD 6.8%)
Day 3 = 7.1 x 10-4 g/l (RSD 2.5%)
12:Ac (20°C)
Day 1 = 9 x 10-5 g/l (RSD 21.8%)
Day 2 = 13 x 10-4 g/l (RSD 1.5%)
Day 3 = 13 x 10-4 g/l (RSD 10.4%)
Effect of pH is not required*
Open for applicability of data to all the SCLP‘s

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Lepidopteran Pheromones

Solubility in organic solvents ‡ Z8-12:Ac 97.7% purity


(state temperature, state purity) 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Totally soluble in organic solvents. No precipitate
was generated
Open for applicability of data to all the SCLP‘s
Surface tension ‡ Z8-12:Ac 97.7% purity
(state concentration and temperature, state 12:Ac 98.9% purity
purity)
(Blend mix ratio 50.2:49.2)
39.9mN/m
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ Z8-12:Ac 97.7% purity
(state temperature, pH and purity) 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Z8-12:Ac
log P = 5.61 (25°C)
12:Ac
log P = 6.25 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
UV/VIS absorption (max.) incl. ‡ Z8-12:Ac 97.7% purity
(state purity, pH) 12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
UV VIS
52.88486486 cm-1 mol-1 l (204nm)
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Z8-12:Ac 97.7% purity
12:Ac 98.9% purity
(Blend mix ratio 50.2:49.2)
Flash point: 126°C
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Summary of representative uses evaluated (Acetate Blend: (Z)-9-Dodecenyl Acetate; Dodecan-1-yl Acetate)
Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Grape Italy ECODIAN® F Eupoecilia VP 20mg/ 2000 Before the 1st 2 60 days n. a. n. a. 2000 n. a.
EA / ambiguella dispen dispenser generation of dispense
Isagro ser s/ha the moth rs/ha x
20mg
=40g

Grape Italy ECODIAN® F Eupoecilia VP 20mg/ 2000- Before the 1st 2 60 days n. a. n. a. 2000 - n. a.
GRAPE / ambiguella dispen 2500 generation of 2500
Isagro ser dispenser the moth dispense
s/ha rs/ha x
20mg
=40g-
50g

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (Z)-9-dodecen-1-yl acetate
(animals and plants) ii) Dodecyl acetate
Toxicologically relevant compounds ‡ ii) (Z)-9-dodecen-1-yl acetate
(environment) ii) Dodecyl acetate

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

(E/Z)-8-dodecen-1-yl acetate, (Z)-9-


dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)


Target / critical effect ‡ No data provided
Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP)

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):

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Lepidopteran Pheromones

No reliable range of naturally occuring backgound


levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
14
RMS/peer review proposal
Substance classified: Acetate Blend:(Z)-9- Xi ―Irritant‖
dodecen-1-yl acetate; dodecyl acetate R38 ―Irritating to skin‖

14
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (Z)-9-dodecen-1-yl acetate


ii) Dodecyl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Acetate Blend: (Z)-9-
96 hr No data
Fish Dodecenyl Acetate; LC50
provided
Dodecan-1-yl Acetate
Acetate Blend: (Z)-9-
48 hr No data
Aquatic invertebrates Dodecenyl Acetate; EC50
(flow-through) provided
Dodecan-1-yl Acetate
Acetate Blend: (Z)-9-
72 hr EbC50 No data
Algae Dodecenyl Acetate;
(static) ErC50 provided
Dodecan-1-yl Acetate
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Lepidopteran Pheromones

Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil i) (Z)-9-dodecen-1-yl acetate
ii) Dodecyl acetate
water i) (Z)-9-dodecen-1-yl acetate
ii) Dodecyl acetate

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

sediment i) (Z)-9-dodecen-1-yl acetate


ii) Dodecyl acetate
groundwater i) (Z)-9-dodecen-1-yl acetate
ii) Dodecyl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

27 Acetate Blend: (7E, 9Z)-Dodecadienyl Acetate; (7E, 9E)-Dodecadienyl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (E,Z)-7,9-dodecadien-1-yl acetate


ii) (E,E)-7,9-dodecadien-1-yl acetate
Chemical name (CA) ‡ i) (E,Z)-7,9-dodecadien-1-ol acetate
ii) (E,E)-7,9-dodecadien-1-ol acetate
CIPAC No ‡ i) 864
ii) 863
CAS No ‡ i) 55774-32-8
ii) 54364-63-5
EC No (EINECS or ELINCS) ‡ i) 259-812-0
ii) --
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C12H22O
ii) C12H22O
Molecular mass ‡ i) 224.344 g/mol
ii) 224.344 g/mol
Structural formula ‡ i)
O

O CH3

ii)
O

O CH3

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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 97.2% purity
298°C at atmospheric pressure; aluminium pierced pan
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) 97.2% purity
Decomposition starts at 250°C; steel closed ‗high
pressure‘ pan;
Open for applicability of data to all the SCLP‘s
Appearance (state purity) ‡ >75% purity
(19% other geometric isomers)
Total with isomers 94% purity
light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 97.2% purity
1.7E-2 Pa (20°C)
purity) ‡ 3.2E-1 Pa (25°C)
Open for applicability of data to all the SCLP‘s

Henry‘s law constant ‡ 3


H = 0.006 kPa m /mol
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 97.5% purity
-3
0.67 x 10 g/l (20°C)
purity and pH) ‡ pH 6.2
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 97.5% purity
Solubilities at 20°C
(state temperature, state purity)

Open for applicability of data to all the SCLP‘s


Surface tension ‡ 97.2% purity
49.7mN/m at 0.01% in pure water (20°C)
(state concentration and temperature, state
Open for applicability of data to all the SCLP‘s
purity)
Partition co-efficient ‡ The study for Z-8-dodecenyl acetate can be
(state temperature, pH and purity) regarded as representative.
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application
Open for applicability of data to all the SCLP‘s

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Flammability ‡ (state purity) SCLP actives are not flammables (statement)


82.21% purity
Flash point: 138°C
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Lepidopteran Pheromones

Summary of representative uses evaluated Acetate Blend: ((7E, 9Z)-Dodecadienyl Acetate; (7E, 9E)-Dodecadienyl Acetate)
Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Grape AT Pheromone F Lobesia VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES dispenser / botrana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg =
IT r) in Funnel 1st species 10-12
NL trap occurring mg /ha
UK

Grape AT XLure F Lobesia VP 2 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES dispenser / botrana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 2
GE (SiberHegne dispenser moth flight of mg = 20-
IT r) in Funnel 1st species 24
NL trap occurring mg/ha
UK

Grape AT Pheromone F Lobesia VP 10 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES dispenser / botrana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 10
GE (SiberHegne dispenser moth flight of mg =
IT r) in Delta 1st species 100-120
NL trap occurring mg/ha
UK

VP vapour releasing product in closed dispenser


n.a. not applicable

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.
Open

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (E,Z)-7,9-dodecadien-1-yl acetate
(animals and plants) ii) (E,E)-7,9-dodecadien-1-yl acetate
Toxicologically relevant compounds ‡ i) (E,Z)-7,9-dodecadien-1-yl acetate
(environment) ii) (E,E)-7,9-dodecadien-1-yl acetate

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

(E/Z)-8-dodecen-1-yl acetate, (Z)-9-


dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)


Target / critical effect ‡ No data provided
Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP)

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):

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Lepidopteran Pheromones

No reliable range of naturally occuring backgound


levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
15
RMS/peer review proposal
Substance classified: Acetate blend: (E,Z)-7,9- Xi ―Irritant‖
dodecadien-1-yl acetate, (E,E)-7,9- R38 ―Irritating to skin‖
dodecadien-1-yl acetate

15
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (E,Z)-7,9-dodecadien-1-yl acetate


ii) (E,E)-7,9-dodecadien-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Acetate Blend: (7E, 9Z)- No data
Dodecadienyl Acetate; 96 hr provided
Fish LC50
(7E, 9E)-Dodecadienyl (semi-static)
Acetate
Acetate Blend: (7E, 9Z)- No data
Dodecadienyl Acetate; 48 hr provided
Aquatic invertebrates EC50
(7E, 9E)-Dodecadienyl (flow-through)
Acetate
Acetate Blend: (7E, 9Z)- No data
Dodecadienyl Acetate; 72 hr EbC50 provided
Algae
(7E, 9E)-Dodecadienyl (static) ErC50
Acetate
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

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Lepidopteran Pheromones

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue

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soil i) (E,Z)-7,9-dodecadien-1-yl acetate


ii) (E,E)-7,9-dodecadien-1-yl acetate
water i) (E,Z)-7,9-dodecadien-1-yl acetate
ii) (E,E)-7,9-dodecadien-1-yl acetate
sediment i) (E,Z)-7,9-dodecadien-1-yl acetate
ii) (E,E)-7,9-dodecadien-1-yl acetate
groundwater i) (E,Z)-7,9-dodecadien-1-yl acetate
ii) (E,E)-7,9-dodecadien-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

28 Acetate Blend: (7Z, 11Z)-Hexadecadien-1-yl Acetate; (7Z, 11E)-Hexadecadien-1-yl


Acetate
Listing of end points
Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (Z,Z)-7,11-hexadecadien-1-yl acetate


ii) (Z,E)-7,11-hexadecadien-1-yl acetate
Chemical name (CA) ‡ i) (Z,Z)-7,11-hexadecadien-1-ol acetate
ii) (Z,E)-7,11-hexadecadien-1-ol acetate
CIPAC No ‡ i) 866
ii) 865
CAS No ‡ i) & ii) 53042-79-8
i) 52207-99-5
ii) 51606-94-4
EC No (EINECS or ELINCS) ‡ i) 257-737-8
ii) --
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C18H32O2
ii) C18H32O2
Molecular mass ‡ i) 280.451 g/mol
ii) 280.451 g/mol
Structural formula ‡ i)
O

O CH3

ii)
O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ blend >90.1% purity (ZZ 47.4%, ZE 42.7%)
(other geometric isomers <3.5%)
Total blend with isomers: >93.6%
170~175°C/3Pa
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ blend >90.1% purity (ZZ 47.4%, ZE 42.7%)
(other geometric isomers <3.5%)
Total blend with isomers: >93.6%
light yellow transparent oily liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state blend >90.1% purity (ZZ 47.4%, ZE 42.7%)
purity) ‡ (other geometric isomers <3.5%)
Total blend with isomers: >93.6%
0.00008Pa (20°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ blend >90.1% purity (ZZ 47.4%, ZE 42.7%)
(state temperature, state purity) (other geometric isomers <3.5%)
Total blend with isomers: >93.6%
soluble in n-hexane, n-pentane, benzene, toluene,
methanol, ethanol, ethyl ether, acetone, methylene
chloride, chloroform, acetonitrile, THF, DMF, acetic
acid
Insoluble in DMSO and ethylene glycol
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s

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Partition co-efficient ‡ blend >90.1% purity (ZZ 47.4%, ZE 42.7%)


(state temperature, pH and purity) (other geometric isomers <3.5%)
Total blend with isomers: >93.6%
more than 4 (log P o/w) (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
blend >90.1% purity (ZZ 47.4%, ZE 42.7%)
(other geometric isomers <3.5%)
Total blend with isomers: >93.6%
Flash point: 167°C
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (Acetate Blend: (7Z, 11Z)-Hexadecadien-1-yl Acetate; (7Z, 11E)-Hexadecadien-1-yl Acetate)
Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Cotton Greece Frustrate F Pectinophora VP 160mg 160mg/ha Before the 1st 1 n. a. n. a. n. a. 250 n. a.
Spain PBW / gossypiella /dispe generation of dispense
AgriSense nser the moth rs/ha x
160mg =
40g/ha

Cotton AT Pheromone F Pectinophora VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / gossypiella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Cotton Greece CHECKMAT F Pectinophora CS 28- 28- Before the 1st 8 When n. a. n a. 28- n. a.
Spain E PBW-FXL gossypiella LVS 140ml 140ml/ha generation of required 140ml/h
(All / the moth a x 8
Field Suterra applicati
Trials) (Consep ons =
GmbH) 224-
1120
ml/ha

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VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (Z,Z)-7,11-hexadecadien-1-yl acetate
(animals and plants) ii) (Z,E)-7,11-hexadecadien-1-yl acetate
Toxicologically relevant compounds ‡ i) (Z,Z)-7,11-hexadecadien-1-yl acetate
(environment) ii) (Z,E)-7,11-hexadecadien-1-yl acetate

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
Rat LC50 inhalation ‡ > 6.72 mg/L air/4h, (whole-body)
> 4.84 mg/L air/4h (nose-only)
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria;
and in vitro gene mutation in mammalian
cells based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate

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Lepidopteran Pheromones

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity
Reproduction target / critical effect ‡ No data provided
Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated

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ARfD ‡ Not allocated for derivation of


reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP); Microencapsulated vapour releasing
system, spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

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Lepidopteran Pheromones

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
16
RMS/peer review proposal
Substance classified: Acetate Blend: (Z,Z)- None
7,11-hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate

16
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open


Spray application: not fully established

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open


Spray application: no risk assessment submitted

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (Z,Z)-7,11-hexadecadien-1-yl acetate


ii) (Z,E)-7,11-hexadecadien-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Acetate Blend: (7Z, 11Z)-
No reliable
Hexadecadien-1-yl 96 hr
Fish LC50 data
Acetate; (7Z, 11E)-
provided
Hexadecadien-1-yl Acetate
Acetate Blend: (7Z, 11Z)-
No reliable
Hexadecadien-1-yl 48 hr
Aquatic invertebrates EC50 data
Acetate; (7Z, 11E)- (flow-through)
provided
Hexadecadien-1-yl Acetate
Acetate Blend: (7Z, 11Z)-
No reliable
Algae Hexadecadien-1-yl 72 hr EbC50
data
Acetate; (7Z, 11E)- (static) ErC50
provided
Hexadecadien-1-yl Acetate
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

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Lepidopteran Pheromones

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)

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Compartment Ecotoxicologically relevant residue


soil i) (Z,Z)-7,11-hexadecadien-1-yl acetate
ii) (Z,E)-7,11-hexadecadien-1-yl acetate
water i) (Z,Z)-7,11-hexadecadien-1-yl acetate
ii) (Z,E)-7,11-hexadecadien-1-yl acetate
sediment i) (Z,Z)-7,11-hexadecadien-1-yl acetate
ii) (Z,E)-7,11-hexadecadien-1-yl acetate
groundwater i) (Z,Z)-7,11-hexadecadien-1-yl acetate
ii) (Z,E)-7,11-hexadecadien-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

29 Aldehyde Blend: (Z)-9-hexadecenal; (Z)-11-hexadecenal; (Z)-13-octadecenal

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (Z)-9-hexadecenal


ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal
Chemical name (CA) ‡ i) (Z)-9-hexadecenal
ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal
CIPAC No ‡ i) 881
ii) 875
iii) 878
CAS No ‡ i) 56219-04-6
ii) 53939-28-9
iii) 58594-45-9
EC No (EINECS or ELINCS) ‡ i) 260-064-2
ii) 258-876-7
iii) 261-349-4
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C16H30O
ii) C16H30O
iii) C18H34O
Molecular mass ‡ i) 238.41 g/mol
ii) 238.41 g/mol
iii) 266.468 g/mol
Structural formula ‡ i)
O

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ii)
O

iii)
O

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ blend >92% purity
(Z9-16:Al = 8.4%, Z11-16:Al = 81.4%, Z13:Al =
10.2%)
Z9-16:Al = 136°C/0.9mmHg
Z11-16:Al = 125°C/0.2mmHg
Z13:Al = 167 °C/1.5mmHg
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ blend >92% purity
(Z9-16:Al = 8.4%, Z11-16:Al = 81.4%, Z13:Al =
10.2%)
light yellow liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state The study for (Z)-9-Hexadecenal can be regarded
purity) ‡ as representative.
-2
3.11 x 10 Pa (25°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ blend >92% purity
(state temperature, state purity) (Z9-16:Al = 8.4%, Z11-16:Al = 81.4%, Z13:Al =
10.2%)
readily soluble in common organic solvents
including n-heptane, xylene, acetone
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ Data required
(state temperature, pH and purity) Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s

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UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 61°C
blend >92% purity
(Z9-16:Al = 8.4%, Z11-16:Al = 81.4%, Z13:Al =
10.2%)
Reference required
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (Aldehyde Blend: (Z)-9-hexadecenal; (Z)-11-hexadecenal; (Z)-13-octadecenal)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Rice Spain Selibate CS F Chilo VP 400mg 50-100 Before begin 1 n. a. n. a. n. a. 50-100 n. a.


/ suppressalis dispen dispenser/ of 1.st dispense
AgriSense ser ha generation r x
moth flight of 400mg =
1.st species 20-
occurs 40g/ha

Rice Spain FERSEX F Chilo VP 6mg/di 5 Before begin 1 n. a. n. a. n. a. 5 n. a.


ChS / suppressalis spens dispenser/ of 1.st dispense
SEDQ er ha generation r x 6mg
4,6 mass moth flight of =
g/kg trapping 1.st species 0.03g/ha
(1) occurs

0,4 80-100 Before begin 1 80-100


g/disp dispenser of 1.st disp./ha
enser s/ha generation x 0,4 g
(2) mating moth flight of /disp.=
disruption 1.st species 32-40
occurs g/ha

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (Z)-9-hexadecenal
(animals and plants) ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal
Toxicologically relevant compounds ‡ i) (Z)-9-hexadecenal
(environment) ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from: (Z)-11-
hexadecenal
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from: (Z)-11-
hexadecenal
Rat LC50 inhalation ‡ 4.46 (females) mg/L air/4 h whole body R20
exposure
based on bridging from: (Z)-11-
hexadecenal
Skin irritation ‡ Non-irritant
based on bridging from: (Z)-11-
hexadecenal
Eye irritation ‡ Non-irritant
based on bridging from: (Z)-11-
hexadecenal
Skin sensitisation ‡ Sensitiser (based on chemical structure) R43

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

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Genotoxicity ‡ (Annex IIA, point 5.4)

Data gap: Genotoxicity tests with SCLP


aldehydes have to be provided

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)


Regular medical checks of manufacturing plant
personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
17
RMS/peer review proposal
Substance classified: Aldehyde Blend: (Z)-9- Xn ―Harmful‖
hexadecenal, (Z)-11-hexadecenal, (Z)-13- R20 ―Harmful by inhalation‖
octadecenal
R43 ―May cause sensitisation by skin contact‖

17
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and
to demonstrate that the use of SCLPs as a plant protection product according to the use pattern will
result in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (Z)-9-hexadecenal


ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Aldehydes)
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Aldehyde Blend: (Z)-9-
hexadecenal; (Z)-11- No data
Fish 96 hr LC50
hexadecenal; (Z)-13- provided
octadecenal
Aldehyde Blend: (Z)-9-
hexadecenal; (Z)-11- 48 hr No data
Aquatic invertebrates EC50
hexadecenal; (Z)-13- (flow-through) provided
octadecenal
Aldehyde Blend: (Z)-9-
hexadecenal; (Z)-11- 72 hr EbC50 No data
Algae
hexadecenal; (Z)-13- (static) ErC50 provided
octadecenal
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data provided


Acute contact toxicity No data provided

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
No data provided.

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil i) (Z)-9-hexadecenal
ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal
water i) (Z)-9-hexadecenal
ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal
sediment i) (Z)-9-hexadecenal
ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal
groundwater i) (Z)-9-hexadecenal

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ii) (Z)-11-hexadecenal
iii) (Z)-13-octadecenal

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

30 Blend Mixture: E-5-Decen-1-yl Acetate; E-5-Decen-1-ol

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (E)-5-decen-1-yl acetate


ii) (E)-5-decen-1-ol
Chemical name (CA) ‡ i) (E)-5-decen-1-ol acetate
ii) (E)-5-decen-1-ol
CIPAC No ‡ i) 870
ii) 869
CAS No ‡ i) 38421-90-8
ii) 56578-18-8
EC No (EINECS or ELINCS) ‡ i) 253-923-8
ii) 260-267-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C12H22O2
ii) C10H20O
Molecular mass ‡ i) 198.305 g/mol
ii) 156.269 g/mol
Structural formula ‡ i)
O

O CH3

ii)
OH

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
226-230°C
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
colourless liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
purity) ‡ 14.4%)
E5-10:Ac = 1.085 Pa (20°C)
E5-10OH = 1.364 Pa (20°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
purity and pH) ‡ 14.4%)
E5-10:Ac (20°C)
Day 1 = 6.0 x 10-3 g/l (RSD 6.1%)
Day 2 = 8.6 x 10-3 g/l (RSD 4.8%)
Day 3 = 7.2 x 10-3 g/l (RSD 10.4%)
E5-10:OH (20°C)
Day 1 = 0.138 g/l (RSD 0.84%)
Day 2 = 0.139 g/l (RSD 0.46%)
Day 3 = 0.137 g/l (RSD 1.68%)
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
(state temperature, state purity) 14.4%)
easily soluble in common organic solvent, no
precipitate generated
Open for applicability of data to all the SCLP‘s
Surface tension ‡ blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
(state concentration and temperature, state 14.4%)
purity) 37mN/m at in pure water
Open for applicability of data to all the SCLP‘s

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Partition co-efficient ‡ blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =


(state temperature, pH and purity) 14.4%)
log p = 4.95 (20°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
(state purity, pH) 14.4%)
UV VIS spectrum
232.8081967 cm-1 mol-1 l (206nm)
5.384153005 cm-1 mol-1 l (580nm)
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 110°C
blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (Blend Mixture: 5-Decen-1-yl Acetate; 5-Decen-1-ol)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Peach Italy RAK 5+6 / F Anarsia VP 550 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
BASF lineatella mg dispenser/ of 1.st dispense
/dispe ha generation r x 550
nser moth flight of mg =
1.st species 275 g/ha
occurring

Stone Spain CHECKMAT F Anarsia VP 100mg 500 Before the 1st 2 When n. a. n. a. 500 n. a.
Fruits, E lineatella /dispe dispenser generation of required dispense
Tree Nut PTB / nser s/ha the moth rs/ha x
Crops Suterra 100mg =
(Consep 50g/ha x
GmbH) 2
applicati
ons =
100g/ha

Stone Italy CHECKMAT F Anarsia VP 200mg 375 Before the 1st 2 When n. a. n. a. 375 n. a.
Fruits, E lineatella /dispe dispenser generation of required dispense
Tree Nut Spain - PTB-XL 7 nser s/ha the moth rs/ha x
Crops (Field Suterra 100mg =
Trials) (Consep 50g/ha x
GmbH) 2
applicati
ons =
100g/ha

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Stone Spain CHECKMAT F Anarsia CS 143- 143- Before the 1st 7 When n. a. n. a. 143- n. a.
Fruits, Italy E lineatella LVS 571ml/ 571ml/ha generation of required 571ml/h
Tree Nut Greece PTB-F / CS the moth a X 7
Crops (All Suterra applicati
Field (Consep ons =
Trials) GmbH) 1001-
3997ml/
ha

Stone fruit, Italy CHECKMAT F Grapholita VP 255 375 Before the 1st 2 When n. a. n. a. 375 n. a.
tree nut E SF-XL / molesta + mg dispenser generation of required dispense
crops Suterra Anarsia PTB s/ha the moth rs/ha x
(Consep lineatella 255 mg
GmbH) = 95.6
g/ha x 2
applicati
ons =
191.2
g/ha

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Stone fruit, Spain CHECKMAT F Grapholita VP 200 375-500 Before the 1st 2 When n. a. n. a. 375- n. a.
tree nut E SF / molesta + mg dispenser generation of required dispense
crops Suterra Anarsia s/ha the moth rs/ha x
(Consep lineatella 200 mg
GmbH) = 75
g/ha x 2
applicati
ons =
150g/ha

500-
dispense
rs/ha x
200 mg
= 100
g/ha x 2
applicati
ons =
200g/ha
Italy ECODIAN® F Anarsia VP 10mg/ 2000- Before the 1st 2 50 days n. a. n. a. 2000- n. a.
Peach (DPR AL / lineatella dispen 2500- generation of 2500-
Apricot 290) Isagro ser 3000 the moth 3000
Spain dispenser dispense
s/ha (low- rs/ha x
mod-high 10mg =
density 20g-25g-
pest) 30g/ha

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Peach AT Pheromone F Anarsia VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Nectarine ES dispenser / lineatella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r in Funnel 1st species 12
NL trap occurring mg/ha
UK 10
mg/dis 10-12
penser 10-12 dispense
dispenser/ r/ha x 10
ha, mg =
dispenser 100-120
in Funnel mg/ha
trap

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (E)-5-decen-1-yl acetate
(animals and plants) ii) (E)-5-decen-1-ol
Toxicologically relevant compounds ‡ i) (E)-5-decen-1-yl acetate
(environment) ii) (E)-5-decen-1-ol

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5050 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
Rat LC50 inhalation ‡ > 5.045 mg/L air/4h (nose-only)
Skin irritation ‡ Irritant R38
Eye irritation ‡ Irritant R36
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria;
and no genotoxic potential in vitro gene
mutation assay in mammalian cells and
chromosome aberration tests based on
bridging from other SCLP acetate and
alcohol: (E/Z)-8-dodecen-1-yl acetate, (Z)-
9-dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (E, E)-8,10-
dodecadien-1-ol

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Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser, No data available


microencapsulated vapour releasing system,
spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

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Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
18
RMS/peer review proposal
Substance classified: Blend Mixture: (E)-5- Xi ―Irritant‖
decen-1-yl acetate, (E)-5-decen-1-ol R36 ―Irritating to eyes‖
R38 ―Irritating to skin‖

18
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open


Spray application: not fully established

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open


Spray application: no risk assessment submitted

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (E)-5-decen-1-yl acetate


ii) (E)-5-decen-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2050 mg/kg bw


Dietary toxicity to birds LC50 > 5000 mg/kg feed (based on lowest endpoint of
SCLPs)
Acute toxicity to mammals LD50 > 2000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Blend Mixture: 5-Decen-1-
Fish 96 hr
yl acetate LC50 1.089 mm
(Brachydanio rerio) (semi-static)
5-decen-1-ol
Blend Mixture: 5-Decen-1-
Aquatic invertebrates 48 hr
yl acetate EC50 1.9 mm
(Daphnia magna) (flow-through)
5-decen-1-ol
Blend Mixture: 5-Decen-1-
Algae 72 hr EbC50 0.261 mm
yl acetate
(Scenedesmus subspicatus) (static) ErC50 1.109 mm
5-decen-1-ol
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs)
Acute contact toxicity LD50 > 100 µg a.s./bee (based on lowest endpoint of SCLPs)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based on Mortality
Chrysoperla
Adults lowest endpoint 0.264 50%
carnea Oviposition 8.5%
of SCLPs
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil i) (E)-5-decen-1-yl acetate
ii) (E)-5-decen-1-ol
water i) (E)-5-decen-1-yl acetate
ii) (E)-5-decen-1-ol
sediment i) (E)-5-decen-1-yl acetate

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ii) (E)-5-decen-1-ol
groundwater i) (E)-5-decen-1-yl acetate
ii) (E)-5-decen-1-ol

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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31 Blend Mixture: (E/Z)-8-Dodecenyl Acetate; (Z)-8-Dodecenol

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (E/Z)-8-dodecen-1-yl acetate


ii) (Z)-8-dodecen-1-ol
Chemical name (CA) ‡ i) (E/Z)-8-dodecen-1-ol acetate
ii) (Z)-8-dodecen-1-ol
CIPAC No ‡ i) 871
ii) 880
CAS No ‡ i)—
as individual isomers:
(E) 38363-29-0
(Z) 28079-04-1
ii) 40642-40-8
EC No (EINECS or ELINCS) ‡ i)—
as individual isomers:
(E) 253-904-4
(Z) 248-823-6
ii) 255-019-9
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C14H26O2
ii) C12H22O
Molecular mass ‡ i) 226.359 g/mol
ii) 184.32 g/mol
Structural formula ‡ i) –

E/Z as individual isomers

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Lepidopteran Pheromones

O CH3

O CH3

ii)
OH

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ blend >95% (Z8-12:Ac >89.6%, E8-12:Ac >4.7%,
Z8-12:OH >0.7%)
115-125°C/3mmHg
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ blend >95% (Z8-12:Ac >89.6%, E8-12:Ac >4.7%,
Z8-12:OH >0.7%)
light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state blend >95% (Z8-12:Ac >89.6%, E8-12:Ac >4.7%,
purity) ‡ Z8-12:OH >0.7%)
5.31 x 10-3 mmHg (20°C)
or
0.71 Pa
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ blend >95% (Z8-12:Ac >89.6%, E8-12:Ac >4.7%,
(state temperature, state purity) Z8-12:OH >0.7%)
easily soluble in common organic solvent except
DMSO and ethylene glycol
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ blend >95% (Z8-12:Ac >89.6%, E8-12:Ac >4.7%,
(state temperature, pH and purity) Z8-12:OH >0.7%)
>10000
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives

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UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 108°C
blend >95% (Z8-12:Ac >89.6%, E8-12:Ac >4.7%,
Z8-12:OH >0.7%)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (Blend Mixture: (E/Z)-8-Dodecenyl Acetate; (Z)-8-Dodecenol)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Stone fruit, Spain CHECKMAT F Grapholita VP 180mg 270 Before the 1st 2 When n.a n.a 270 n.a
Pome fruit, E OFM / molesta /dispe dispenser generation of required dispense
Tree Nut Suterra nser s/ha the pest rs/ha x
crops (Consep 180mg =
GmbH) 48.6g/ha
x 2
applicati
ons =
97.2g/ha

Stone fruit, Italy CHECKMAT F Grapholita VP 250mg 270 Before the 1st 2 When n.a n.a 270 n.a
Pome fruit, Spain E OFM-XL / molesta /dispe dispenser generation of required dispense
Tree Nut (All Suterra nser s/ha the pest rs/ha x
crops Field (Consep 250mg =
Trials) GmbH) 67.5g/ha
x 2
applicati
ons =
135g/ha

Pome fruit, Spain CHECKMAT F Grapholita CSL 96- 96- Before the 1st 7 When n.a n.a 96- n.a
Tree Nut Greece E OFM-F / molesta VS 215ml/ 215ml/ha generation of required 215ml/h
crops Germa Suterra CS the pest a x 7
ny (Consep applicati
(All GmbH) ons =
Field 0.672-
Trials) 1.505l/h
a
Italy (In
Review
)

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Stone fruit, Italy CHECKMAT F Grapholita VP 250 375 Before the 1st 2 When n.a. n.a. 375 n.a.
tree nut E SF-XL / molesta + mg dispenser generation of required dispense
crops Suterra Anarsia OFM s/ha the moth rs/ha x
(Consep lineatella 250 mg
GmbH) (255 mg)
= 93.75
(95.63)
g/ha x 2
applicati
ons =
187.5
(191.3)
g/ha
Stone fruit, Spain CHECKMAT F Grapholita VP 180 375-500 Before the 1st 2 When n.a. n.a. 375- n.a.
tree nut E SF / molesta + mg dispenser generation of required dispense
crops Suterra Anarsia OFM s/ha the moth rs/ha x
(Consep lineatella 180 mg
GmbH) = 67.5
g/ha x 2
applicati
ons =
135.0g/h
a

500-
dispense
rs/ha x
180 mg
= 90
g/ha x 2
applicati
ons =
180g/ha

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Peach Italy ECODIAN® F Cydia VP 10mg/ 2000- Before the 1st 2/3 60 days n.a. n.a. 2000- N.A.
Nectarine CM / molesta dispen 2500- generation of 2500-
Apple Isagro ser 3000 the moth 3000
Pear dispenser dispense
s/ha (low- rs/ha x
mod-high 10mg =
density 20g-25g-
pest) 30g/ha

Apricot, Spain Grapholita F Cydia VP (1) (1) Before the 1st 1 n.a. n.a. n.a. (1) N.A.
Plum, Molesta sex molesta generation of
Almond pheromone / the moth
SEDQ

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (E/Z)-8-dodecen-1-yl acetate
(animals and plants) ii) (Z)-8-dodecen-1-ol
Toxicologically relevant compounds ‡ i) (E/Z)-8-dodecen-1-yl acetate
(environment) ii) (Z)-8-dodecen-1-ol

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5050 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
Rat LC50 inhalation ‡ > 4.74 mg/L air/4h (nose-only)
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Sensitiser (M&K test) R43
based on bridging from SCLP alcohol: (E,
E)-8,10-dodecadien-1-ol

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria;
and in vitro gene mutation assay in
mammalian cells and chromosome
aberration tests based on bridging from
other SCLP acetate and alcohol: (E/Z)-8-
dodecen-1-yl acetate, (Z)-9-dodecen-1-yl
acetate, (E,Z)-7,9-dodecadien-1-yl acetate,
(E, E)-8,10-dodecadien-1-ol

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Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser, No data available


microencapsulated vapour releasing system,
spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

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Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
19
RMS/peer review proposal
Substance classified: Blend Mixture: (E/Z)-8- Xi ―Irritant‖
dodecen-1-yl acetate, (Z)-8-dodecen-1-ol R43 ―May cause sensitisation by skin contact‖

19
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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Lepidopteran Pheromones

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open


Spray application: not fully established

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open


Spray application: no risk assessment submitted

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (E/Z)-8-dodecen-1-yl acetate


ii) (Z)-8-dodecen-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2000 mg/kg bw


Dietary toxicity to birds LC50 > 5000 mg/kg feed
Acute toxicity to mammals LD50 > 5050 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Blend Mixture: E/Z-8- No reliable
96 hr
Fish Dodecenyl acetate LC50 data
(semi-static)
Z-8-Dodecen-1-ol provided
Blend Mixture: E/Z-8-
Aquatic invertebrates 48 hr
Dodecenyl acetate EC50 0.31 n
(Daphnia magna) (semi-static)
Z-8-Dodecen-1-ol
Blend Mixture: E/Z-8-
Algae 72 hr EbC50 No data
Dodecenyl acetate
(static) ErC50 provided
Z-8-Dodecen-1-ol
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs)
Acute contact toxicity LD50 > 100 µg a.s./bee (based on lowest endpoint of SCLPs)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based on Mortality
Chrysoperla
Adults lowest endpoint 0.264 50%
carnea Oviposition 8.5%
of SCLPs
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil i) (E/Z)-8-dodecen-1-yl acetate
ii) (Z)-8-dodecen-1-ol
water i) (E/Z)-8-dodecen-1-yl acetate
ii) (Z)-8-dodecen-1-ol
sediment i) (E/Z)-8-dodecen-1-yl acetate

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ii) (Z)-8-dodecen-1-ol
groundwater i) (E/Z)-8-dodecen-1-yl acetate
ii) (Z)-8-dodecen-1-ol

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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32 Blend Mixture: (Z)-11-Hexadecenal; (Z)-11-Hexadecen-1-yl Acetate

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ i) (Z)-11-hexadecenal


ii) (Z)-11-hexadecen-1-yl acetate
Chemical name (CA) ‡ i) (Z)-11-hexadecenal
ii) (Z)-11-hexadecen-1-ol acetate
CIPAC No ‡ i) 875
ii) 874
CAS No ‡ i) 53939-28-9
ii) 34010-21-4
EC No (EINECS or ELINCS) ‡ i) 258-876-7
ii) 251-791-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ i) C16H30O
ii) C18H34O2
Molecular mass ‡ i) 238.414 g/mol
ii) 282.467g/mol
Structural formula ‡ i)
O

ii)
O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ blend >92.5% (Z11-16:Ac/Z-11-16:Al ratio
0.83:1.07)
120-132°C/0.3mmHg
Reference required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ blend >92.5% (Z11-16:Ac/Z-11-16:Al ratio
0.83:1.07)
colourless or light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state blend >92.5% (Z11-16:Ac/Z-11-16:Al ratio
purity) ‡ 0.83:1.07)
1.2 X 10-3 - 6 X 10-5 mmHg (20°C)
or
0.16 - 0.008 Pa
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ blend >92.5% (Z11-16:Ac/Z-11-16:Al ratio
(state temperature, state purity) 0.83:1.07)
soluble in n-hexane, cyclohexane, benzene,
toluene, methylene chloride, carbon tetrachloride,
chloroform, acetonitrile, THF, acetone, DMF,
methanol, ethanol, ethyl ether
Insoluble in DMSO and ethylene glycol
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s

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Partition co-efficient ‡ blend >92.5% (Z11-16:Ac/Z-11-16:Al ratio


(state temperature, pH and purity) 0.83:1.07)
>10000
Reference required
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 152°C
blend >92.5% (Z11-16:Ac/Z-11-16:Al ratio
0.83:1.07)
Reference required#
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (Blend Mixture: (Z)-11-Hexadecanal; (Z)-11-Hexadecen-1-yl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Vegetables Spain CHECKMAT F Plutella CSL 225- 225- Before the 1st 3 Per crop n.a. n.a. 225- n.a.
, (Field E DBM-F / xylostella VS 450ml/ 450ml/ha generation of cycle 450ml/h
Annual and Trials) Suterra CS the moth a X 3
Perennial (Consep applicati
Flowers, GmbH) ons =
Flowering 0.675-
Shrubs, 1.35l/ha
Ornamenta
l Plants

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set.
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)

Rate and extent of oral absorption ‡ No data provided


Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ i) (Z)-11-hexadecenal
(animals and plants) ii) (Z)-11-hexadecen-1-yl acetate
Toxicologically relevant compounds ‡ i) (Z)-11-hexadecenal
(environment) ii) (Z)-11-hexadecen-1-yl acetate

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP acetate
and aldehyde: (E/Z)-8-dodecen-1-yl
acetate, (Z)-9-dodecen-1-yl acetate, (E,Z)-
7,9-dodecadien-1-yl acetate, (Z)-9-
tetradecen-1-yl acetate, (Z)-11-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate, (Z)-11-hexadecenal
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP acetate
and aldehyde: (Z)-9-tetradecen-1-yl
acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate, (Z)-
11-hexadecenal
Rat LC50 inhalation ‡ 4.46 (females) mg/L air/4h whole body R20
exposure
based on bridging from SCLP aldehyde:
(Z)-11-hexadecenal
Skin irritation ‡ Irritant R38
based on bridging from SCLP acetate :
(E,Z)-7,9-dodecadien-1-yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP acetate
and aldehyde: (E/Z)-8-dodecen-1-yl
acetate, (Z)-9-dodecen-1-yl acetate, (E,Z)-
7,9-dodecadien-1-yl acetate, (Z)-9-
tetradecen-1-yl acetate, (Z)-11-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate, (Z)-11-hexadecenal

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Skin sensitisation ‡ Sensitiser (based on chemical structure of R43


SCLP aldehydes)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

Data gap: Genotoxicity tests with SCLP


aldehydes have to be provided

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

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Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP), microencapsulated vapour releasing
system, spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.

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Workers Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
20
RMS/peer review proposal
Substance classified: Blend Mixture: (Z)-11- Xn ―Harmful‖
hexadecenal; (Z)-11-hexadecen-1-yl acetate R20 ―Harmful by inhalation‖
R38 ―Irritating to skin‖
R43 ―May cause sensitisation by skin contact‖

20
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open


Spray application: not fully established

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open


Spray application: no risk assessment submitted

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment i) (Z)-11-hexadecenal


ii) (Z)-11-hexadecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones(based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2000 mg/kg bw (based on lowest endpoint of
SCLPs)
Dietary toxicity to birds LC50 > 5000 mg/kg feed (based on lowest endpoint of
SCLPs)
Acute toxicity to mammals LD50 > 2000 mg/kg bw (based on lowest endpoint of
SCLPs)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Blend Mixture: (Z)-11-
96 hr No data
Fish Hexadecenal; (Z)-11- LC50
provided
Hexadecen-1-yl Acetate
Blend Mixture: (Z)-11-
48 hr No data
Aquatic invertebrates Hexadecenal; (Z)-11- EC50
(flow-through) provided
Hexadecen-1-yl Acetate
Blend Mixture: (Z)-11-
72 hr EbC50 No data
Algae Hexadecenal; (Z)-11-
(static) ErC50 provided
Hexadecen-1-yl Acetate
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs)

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Acute contact toxicity LD50 > 100 µg a.s./bee (based on lowest endpoint of SCLPs)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
Based on - 19%
Mortality
Chrysoperla lowest
Adults 0.264 50%
carnea endpoint of Oviposition 8.5%
SCLPs
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil i) (Z)-11-hexadecenal
ii) (Z)-11-hexadecen-1-yl acetate
water i) (Z)-11-hexadecenal

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ii) (Z)-11-hexadecen-1-yl acetate


sediment i) (Z)-11-hexadecenal
ii) (Z)-11-hexadecen-1-yl acetate
groundwater i) (Z)-11-hexadecenal
ii) (Z)-11-hexadecen-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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The monograph was prepared under the responsibility of:

Physical and chemical properties and methods of analysis:


Angelina Jirgal, Wolfgang Bergermayer
Toxicology and metabolism:
Alexandra Fischer, Marion Burger
Residue data:
Claudia Wacha
Environmental fate and behaviour:
Michael Stemmer, Natalie Hutzenlaub
Ecotoxicology:
Anja Bartels, Wolfgang Krämer, Daniela Jölli, Britta Möbes-Hansen

Coordinators:
Gabriele Kovacs (former coordinator), Marion Richter (now Burger, former coordinator),
Wolfgang Bergermayer (current coordinator)

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General comment: Where appropriate, the lists of endpoints were modified according to the format for
the listing of endpoints proposed in appendix 9 of the OECD Series on Pesticides (Number 12):
Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for
Arthropod Pest Control ENV/JM/MONO(2001)12.

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1 E-5-Decen-1-yl Acetate

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ No ISO common name


Function (e.g. fungicide) Semio-chemicals

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E)-5-decen-1-yl acetate


Chemical name (CA) ‡ (E)-5-decen-1-ol acetate
CIPAC No ‡ 870
CAS No ‡ 38421-90-8
EC No (EINECS or ELINCS) ‡ 253-923-8
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C12H22O2
Molecular mass ‡ 198.305 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Data required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Data required
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 1.085 Pa (20°C)
purity) ‡ 99% purity
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 99% purity
purity and pH) ‡ 20°C
Day 1 = 6.0 x 10-3 g/l (RSD 6.1%)
Day 2 = 8.6 x 10-3 g/l (RSD 4.8%)
Day 3 = 7.2 x 10-3 g/l (RSD 10.4%)
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 80-100% soluble
(state temperature, state purity) whole SCLP acetate group
80-99%purity.
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
The study for Z-8-dodecenyl acetate can be regarded as
Partition co-efficient ‡
representative.
(state temperature, pH and purity) log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‟s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)

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Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

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Summary of representative uses evaluated (5-Decen-1-yl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
(c)

Type Conc. method growth number interval kg water L/ha**) kg


of as kind stage & min max between as/hL**) as/ha**)
season application
min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Peach Italy RAK 5+6 F Anarsia VP 550 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
(BASF) lineatella mg dispenser/ of 1.st dispense
/dispe ha generation r x 550
nser moth flight of mg =
1.st species 275 g/ha
occurring

Peach, Italy ISONET A F Anarsia VP 420 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Nectarine, Spain (BASF) lineatella mg dispenser/ of 1.st dispense
Apricot, Portug /dispe ha generation r x 420
Plum al nser moth flight of mg =
1.st species 210 g/ha
occurring

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique)


Open
Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical
technique and LOQ for methods for monitoring No residue definition set
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)
RMS/peer review proposal
Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E)-5-decen-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (E)-5-decen-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound

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levels could be retrieved, a data gap has been


identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
21
RMS/peer review proposal
Substance classified: (E)-5-decen-1-yl acetate Xi ―Irritant‖
R38 ―Irritating to skin‖

21
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil – Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E)-5-decen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae 72 hr EbC50
E-5-Decen-1-yl Acetate No data
ErC50
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E)-5-decen-1-yl acetate
water (E)-5-decen-1-yl acetate
sediment (E)-5-decen-1-yl acetate
groundwater (E)-5-decen-1-yl acetate

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Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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2 (E)-8-Dodecenyl Acetate

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E)-8-dodecen-1-yl acetate


Chemical name (CA) ‡ (E)-8-dodecen-1-ol acetate
CIPAC No ‡ 871
CAS No ‡ 38363-29-0
EC No (EINECS or ELINCS) ‡ 253-904-4
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H26O2
Molecular mass ‡ 226.359 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 120-125°C/390Pa
Purity 57%
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Light yellow transparent liquid
Purity 57%
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 0.67 Pa (20°C)
purity) ‡ Purity 57%
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state Insoluble in water, <0.002g/l
purity and pH) ‡ 20°C
pH= 4.8
Open for applicability of data to all the SCLP‟s
Effect of pH is not required*
Solubility in organic solvents ‡ 80-100% soluble
(state temperature, state purity) whole SCLP acetate group
80-99%purity.
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 – 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
The study for Z-8-dodecenyl acetate can be regarded as
Partition co-efficient ‡
representative.
(state temperature, pH and purity)
Log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 108°C (purity and reference not
stated)
Open for applicability of data to all the SCLP‘s

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Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((E)-8-Dodecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
I
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Peach AT Pheromone F Cydia molesta VP 1 10-12 Before begin 1 per n.a. n.a. n.a. 10-12 n.a.
Nectarine ES dispenser mg/dis dispenser/ of 1st generatio dispense
FR (DKSH, penser ha, generation n r/ha x 1
GE Siber dispenser moth flight of mg = 10-
IT Hegner) in Funnel 1st species 12
NL trap occurring mg/ha
UK
10-12
10 10-12 dispense
mg/dis dispenser/ r/ha x 1
penser ha, mg =
dispenser 100-120
in Delta mg/ha
trap

Peach, Italy ISOMATE-M F Grapholita VP 75 mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Nectarine, Spain (Shin Etsu, molesta /dispe dispenser/ of 1.st dispense
Apricot, Portug CBC- nser ha generation r x 75
Plum, al Europe) (6% moth flight of mg = 75
Apple, a.i. = 1.st species g/ha (6%
Pear, 4.5mg occurring a.i. =
Quince ) 1000
dispense
r x
4.5mg =
4.5g/ha)

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
I
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Peach, Italy ISOMATE F Grapholita VP 140 250 Before begin 1 n. a. n. a. n. a. 250 n. a.


Nectarine, Spain M-100 molesta mg dispenser/ of 1.st dispense
Apricot, Portug (Shin Etsu, /dispe ha generation r x 140
Plum, al CBC- nser moth flight of mg = 10
Apple, Europe) (6% 1.st species g/ha
Pear, a.i. = occurring (6% a.i.
Quince 8.4mg = 250
) dispense
r x
8.4mg =
2.1g/ha)

Peach, Italy ISOMATE- F Grapholita VP 240 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Nectarine, Spain OFM molesta mg dispenser/ of 1.st dispense
Apricot, Portug (Shin Etsu, /dispe ha generation r x 240
Plum, al CBC- nser moth flight of mg =
Apple, Europe) (6% 1.st species 120 g/ha
Pear, a.i. = occurring (6% a.i.
Quince 14.4) = 500
dispense
r x 14.4
=
7.2g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. Fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
I eg. Biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. Wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes – GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI – minimum pre-harvest interval
(g) Method, eg. High volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. Overall, broadcast, aerial spraying, row, individual plant, between the plants
– type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)
RMS/peer review proposal
Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E)-8-dodecenyl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (E)-8-dodecenyl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)


Target / critical effect ‡ No data provided
Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound

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levels could be retrieved, a data gap has been


identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
22
RMS/peer review proposal
Substance classified: (E)-8-dodecenyl acetate) Xi ―Irritant‖
R38 ―Irritating to skin‖

22
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E)-8-dodecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP

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Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E)-8-dodecen-1-yl acetate
water (E)-8-dodecen-1-yl acetate
sediment (E)-8-dodecen-1-yl acetate
groundwater (E)-8-dodecen-1-yl acetate

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Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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3 (E/Z)-8-Dodecenyl Acetate

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E/Z)-8-dodecen-1-yl acetate


as individual isomers
(E)-8-dodecen-1-yl acetate
(Z)-8-dodecen-1-yl acetate
Chemical name (CA) ‡ (E/Z)-8-dodecen-1-ol acetate
as individual isomers
(E)-8-dodecen-1-ol acetate
(Z)-8-dodecen-1-ol acetate
CIPAC No ‡ 872
CAS No ‡ not allocated
individual isomers:
38363-29-0
28079-04-1
EC No (EINECS or ELINCS) ‡ not allocated
individual isomers:
253-904-4
248-823-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H26O2
Molecular mass ‡ 226.359 g/mol
Structural formula ‡ individual isomers:
O

O CH3
O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 208-212°C
99% purity
Noted reference has not been submitted, is
required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Slightly yellow transparent liquid
99% purity
Noted reference has not been submitted, is
required
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 5.2 x 10-2 mmHg or 6.93 Pa (20°C)
purity) ‡ 99% purity
Noted reference has not been submitted, is
required
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 80-100% soluble
(state temperature, state purity) whole SCLP acetate group
80-99%purity.
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ >10000
(state temperature, pH and purity) 99% purity
Noted reference has not been submitted, is
required
Open for applicability of data to all the SCLP‘s

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Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization


can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 108°C, 99% purity (noted reference
has not been submitted)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Lepidopteran Pheromones

Summary of representative uses evaluated ((E/Z)-8-Dodecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Peach Italy RAK 5+6 F Anarsia VP 550 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
(BASF) lineatella mg dispenser/ of 1.st dispense
/dispe ha generation r x 550
nser moth flight of mg =
1.st species 275 g/ha
occurring

Peach France RAK 5


(BASF)
500
Before begin
Italy RAK 5 450mg 500 dispense
Grapholita of 1.st
(BASF) F VP /dispe dispenser/ 1 n. a. n. a. n. a. r x 450 n. a.
molesta generation
nser ha mg =
moth flight
Spain Quant GM 225 g/ha
(BASF)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)
RMS/peer review proposal
Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E/Z)-8-dodecenyl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (E/Z)-8-dodecenyl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Non-sensitiser (Maximisation test)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

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Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
mammalian cells

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)


Regular medical checks of manufacturing plant
personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
23
RMS/peer review proposal
Substance classified: (E/Z)-8-dodecenyl None
acetate

23
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-8-dodecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E)-8-dodecen-1-yl acetate, (Z)-8-dodecen-1-yl acetate
water (E)-8-dodecen-1-yl acetate, (Z)-8-dodecen-1-yl acetate
sediment (E)-8-dodecen-1-yl acetate, (Z)-8-dodecen-1-yl acetate
groundwater (E)-8-dodecen-1-yl acetate, (Z)-8-dodecen-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)

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RMS/EPCO proposal

Active substance R51/53

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5.4 (Z)-8-Dodecenyl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-8-dodecen-1-yl acetate


Chemical name (CA) ‡ (Z)-8-dodecen-1-ol acetate
CIPAC No ‡ 861
CAS No ‡ 28079-04-1
EC No (EINECS or ELINCS) ‡ 248-823-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H26O2
Molecular mass ‡ 226.359 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Data required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Data required
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 0.157 Pa (20°C)
purity) ‡ 0.245 Pa (25°C)
97.7% purity
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Solubility in water (state temperature, state 97.7% purity
purity and pH) ‡ 20°C
Day 1 = 7.1 x 10-4 g/l (RSD 21.2%)
Day 2 = 8.0 x 10-4 g/l (RSD 6.8%)
Day 3 = 7.1 x 10-4 g/l (RSD 2.5%)
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 97.7% purity
(state temperature, state purity) Organic solvents: n-heptane, xylene, 1,2-
dichloromethane,, methanol, acetone, ethyl acetate)

Totally soluble in all organic solvents. No precipitate


was generated
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ 97.7% purity
(state temperature, pH and purity) log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s

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Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((Z)-8-Dodecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Peach AT Pheromone F Cydia molesta VP 1 10-12 Before begin 1 per n.a. n.a. n.a. 10-12 n.a.
Nectarine ES dispenser mg/dis dispenser/ of 1st generatio dispense
FR (DKSH, penser ha, generation n r/ha x 1
GE Siber dispenser moth flight of mg = 10-
IT Hegner) in Funnel 1st species 12
NL trap occurring mg/ha
UK 10
mg/dis 10-12 10-12
penser dispenser/ dispense
ha, r/ha x 1
dispenser mg =
in Delta 100-120
trap mg/ha

Plum AT Pheromone F Grapholita VP 1 10-12 Before begin 1 per n.a. n.a. n.a. 10-12 n.a.
ES dispenser funebrana mg/dis dispenser/ of 1st generatio dispense
FR (DKSH, penser ha, generation n r/ha x 1
GE Siber dispenser moth flight of mg = 10-
IT Hegner) in Funnel 1st species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Plum France Cydia F Grapholita VP (1) (1) Before begin 1 n. a. n. a. n. a. (1) n. a.


funebrana funebrana of 1.st
sex generation
pheromone moth flight of
(SEDQ) 1.st species
occurring

Peach, Italy ISOMATE-M F Grapholita VP 75 mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Nectarine, Spain (Shin Etsu, molesta /dispe dispenser/ of 1.st dispense
Apricot, Portug CBC- nser ha generation r x 75
Plum, al Europe) (93% moth flight of mg = 75
Apple, a.i. = 1.st species g/ha
Pear, 69.75 occurring (93% a.i.
Quince mg) = 1000
dispense
r x
69.75mg
=
69.75g/h
a)

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country (Company) or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Peach, Italy ISOMATE F Grapholita VP 140 250 Before begin 1 n. a. n. a. n. a. 250 n. a.


Nectarine, Spain M-100 molesta mg dispenser/ of 1.st dispense
Apricot, Portugal (Shin Etsu, /dispe ha generation r x 140
Plum, CBC- nser moth flight of mg = 10
Apple, Europe) (93% 1.st species g/ha
Pear, a.i. = occurring (93% a.i.
Quince 130.2 = 250
mg) dispense
r x
130.2mg
=
32.55g/h
a)

Peach, Italy ISOMATE- F Grapholita VP 240 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Nectarine, Spain OFM molesta mg dispenser/ of 1.st dispense
Apricot, Portugal (Shin Etsu, /dispe ha generation r x 240
Plum, CBC- nser moth flight of mg =
Apple, Europe) (93% 1.st species 120 g/ha
Pear, a.i. = occurring (93% a.i.
Quince 223.2 = 500
mg) dispense
r x
223.2mg
=
111.6g/h
a)

VP vapour releasing product in closed dispenser


n.a. not applicable

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* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is et
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-8-dodecenyl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-8-dodecenyl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,

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(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)


Target/critical effect ‡ No data provided
Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

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Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)


Acute neurotoxicity ‡ No data provided
Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.

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Workers Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
24
RMS/peer review proposal
Substance classified: (Z)-8-Dodecenyl Acetate None

24
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-8-dodecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-8-dodecen-1-yl acetate
water (Z)-8-dodecen-1-yl acetate
sediment (Z)-8-dodecen-1-yl acetate
groundwater (Z)-8-dodecen-1-yl acetate

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Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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5 (Z)-9-Dodecenyl Acetate

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-9-dodecen-1-yl acetate


Chemical name (CA) ‡ (Z)-9-dodecen-1-ol acetate
CIPAC No ‡ 422
CAS No ‡ 16974-11-1
EC No (EINECS or ELINCS) ‡ 241-054-7
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Min. 87% (BASF)
manufactured ‡ Open for other sources
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H26O2
Molecular mass ‡ 226.359 g/mol
Structural formula ‡ O

O CH3

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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 98.6% purity
BP=97°C at 100Pa
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) 98.6% purity
170°C (onset)
Open for applicability of data to all the SCLP‘s
Appearance (state purity) ‡ 92% purity
colourless/light transparent yellow liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 98.6% purity
purity) ‡ 7.3E-2 Pa (20°C)
1.3E-1 Pa (25°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ H = 0.1181 kPa m3/mol
98.6% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 99% purity
purity and pH) ‡ 0.14 x 10-3 g/l (20°C)
pH 6.2
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 91.8% purity
(state temperature, state purity) readily soluble in methanol, toluene, n-heptane,
ethyl acetate, dichloromethane and acetone (20°C)

Open for applicability of data to all the SCLP‘s


Surface tension ‡ 98.6%
(state concentration and temperature, state 20°C
purity)
38.4mN/m at 0.01% in pure water
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ 95.4% purity
(state temperature, pH and purity) log pow = 6.36 (25°C)
pH = 7
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s

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UV/VIS absorption (max.) incl. ‡ 99.2% purity


(state purity, pH) UV VIS (20°C)
Solvent Methanol
1.4276 cm-1 mol-1 l (221.1nm)
380.6 cm-1 mol-1 l (300.34 nm)
Solvent Water
6411.9 cm-1 mol-1 l (200.8nm)
864.2 cm-1 mol-1 l (299.69 nm)
Alkali conditions
-70 cm-1 mol-1 l (300.34nm)
Acidic conditions
1741.3 cm-1 mol-1 l (206.04nm)
397.6 cm-1 mol-1 l (299.69nm)
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((Z)-9-Dodecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Grape Germany RAK1 Neu


/ BASF

RAK1
Luxembour Neu/
g BASF

RAKI 500
230 Before begin
Cochylis/ 500 dispenser
France Eupoecilia mg/ of 1.st
BASF F VP dispenser/h 1 n.a. n.a. n.a. x 230 mg n.a.
ambiguella dispens generation
a = 115
er moth flight
g/ha

Switzerlan Bocep Vit/


d BASF

Italy RAK1/
BASF

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Germany RAK 1+2


BRD/
BASF

Before begin
500
France RAK 1+2 230mg of 1.st
500 dispenser
Cochylis + Eupoecilia BAS generation
F VP dispenser/h 1 n. a. n. a. n. a. x 230mg n. a.
Eudemis / ambiguella 281I/di moth flight of
a = 115
BASF spenser 1.st species
g/ha
occuring

Italy RAK 1+2 /


BASF

Grape France RAK 1+2,


3
generation
s/ Before begin
BASF 500
350mg of 1.st
500 dispenser
Eupoecilia BAS generation
F VP dispenser/h 1 n. a. n. a. n. a. x 350mg n. a.
ambiguella 281/dis moth of 1.st
a = 175
RAK 1+2 / penser occurring
Switzerland g/ha
BASF species

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Italy CHECKM F Eupoecilia CSL 25g 25 g/ha Before the 1st 3 30 n.a n.a. 25g/ha x n.a.
France ATE ambiguella VS generation of 3
Germany EA-F / the moth applicatio
(All Field ns =
Trials) Suterra 75g/ha
(Consep
GmbH)

Grape Switzerla CHECKM F Eupoecilia CSL 12.5g 12.5 (1st Before the 1st 2-4 14 days for n.a. n.a. 12.5 x 6 n.a.
nd ATE ambiguella VS and generatio generation of 1st applicati
(Field EA-F / 25g n and the moth Generation ons
Trials) Suterra heavy (every 2
(Consep rain) 30 days for weeks) =
GmbH) normal use 75g/ha
25g/ha
(normal 25 x 3
use) applicati
ons
(every 4
weeks) =
75 g/ha

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape AT Pheromon F Eupoecilia VP 1 mg 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES e ambiguella /dispe dispenser/ of 1.st generatio dispense
FR dispenser / nser ha, generation n r/ha x 1
GE DKSH dispenser moth flight of mg = 10-
IT (SiberHeg in Funnel 1.st species 12
NL ner) trap occurring mg/ha
UK

Tomato AT Pheromon F Plusia VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES e chalcites mg/dis dispenser/ of 1st generatio dispense
FR dispenser / penser ha, generation n r/ha x 1
GE DKSH dispenser moth flight of mg = 10-
IT (SiberHeg in Funnel 1st species 12
NL ner) trap occurring mg/ha
UK

Vine and Spain Eupoecilia F Eupoecilia VP (1) (1) Before begin 1 n. a. n. a. n. a. (1) n. a.
Lucerne ambiguell ambiguella of 1.st
(Grape) a sex generation
pheromon moth flight of
e/ 1.st species
SEDQ occurring

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Italy ISONET F Eupoecilia VP 380mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


LE / ambiguella /dispe dispenser/ of 1.st dispense
Shin Etsu nser ha generation r x mg =
(CBC- (50% moth flight of g/ha
Europe) a.i. 1.st species (50% a.i.
=190 occurring =
mg) 500dispe
nser
x190mg
=95g/ha)
Grape Italy ISONET L F Eupoecilia VP 180mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
PLUS / ambiguella /dispe dispenser/ of 1.st dispense
Shin Etsu nser ha generation r x
(CBC- (8.3% moth flight of 180mg =
Europe) a.i. 1.st species 90 g/ha
=15m occurring (8.3%
g) a.i. =
500dispe
nser
x15mg
=7.5g/ha
)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-9-dodecen-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-9-dodecen-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

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Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
mammalian cells

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)


Regular medical checks of manufacturing plant
personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP) / Microencapsulated vapour releasing
system, spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

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Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
25
RMS/peer review proposal
Substance classified: (Z)-9-dodecen-1-yl None
acetate

25
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application and spray application: open

Photochemical oxidative degradation in air calculated according to Atkinson (24 h day, Hydroxyl
5 -3
concentration 5 x10 cm ): T1/2 = 5.6 hours

PEC (air) (Annex IIIA, point 9.3)

Dispenser application and spray application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-9-dodecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish 96 hr
Z-9-Dodecenyl acetate LC50 6.37 mm
(Brachydanio rerio) (static)
Aquatic invertebrates 48 hr
Z-9-Dodecenyl acetate EC50 1.1 mm
(Daphnia magna) (static)
Algae 72 hr EbC50 0.3 n
Z-9-Dodecenyl acetate
(Pseudokirchneriella subcapitata) (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-9-dodecen-1-yl acetate
water (Z)-9-dodecen-1-yl acetate
sediment (Z)-9-dodecen-1-yl acetate
groundwater Z)-9-dodecen-1-yl acetate

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Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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6 (7E, 9Z)-Dodecadien-1-yl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E,Z)-7,9-dodecadien-1-yl acetate


Chemical name (CA) ‡ (E,Z)-7,9-dodecadien-1-ol acetate
CIPAC No ‡ 864
CAS No ‡ 54364-62-4
EC No (EINECS or ELINCS) ‡ 259-127-7
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H24O2
Molecular mass ‡ 224.344 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 97.2% purity
298°C at atmospheric pressure; aluminium pierced
pan
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) 97.2% purity
Decomposition starts at 250°C; steel closed ‗high
pressure‘ pan;
Open for applicability of data to all the SCLP‘s
Appearance (state purity) ‡ >75% purity
(19% other geometric isomers)
Total with isomers 94% purity
light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 97.2% purity
purity) ‡ 1.7E-2 Pa (20°C)
3.2E-1 Pa (25°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ H = 0.006 kPa m3/mol
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 97.5% purity
purity and pH) ‡ 0.67 x 10-3 g/l (20°C)
pH 6.2
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 97.5% purity
(state temperature, state purity) Solubilities at 20°C

Open for applicability of data to all the SCLP‘s


Surface tension ‡ 97.2% purity
(state concentration and temperature, state 49.7mN/m at 0.01% in pure water (20°C)
purity)
Open for applicability of data to all the SCLP‘s
The study for Z-8-dodecenyl acetate can be regarded as
Partition co-efficient ‡
representative.
(state temperature, pH and purity)
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s

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Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization


can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
82.21% purity
Flash point: 138°C
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (7E, 9Z)-Dodecadien-1-yl Acetate


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Grape France RAK2


Eudemis 3
Generations 500
/ BASF 350 500 Begin of 1.st dispense
Lobesia
F VP mg/dis dispenser/ generation 1 n. a. n. a. n. a. r x 350 n. a.
botrana
penser ha moth flight mg =
Spain Quant LB / 175 g/ha
BASF

Grape Switzerla RAK 2 Extra


nd /
BASF

500
120 500 Begin of 1.st dispense
Lobesia
F VP mg/dis dispenser/ generation 1 n. a. n. a. n. a. r x 120 n. a.
Italy RAK 2 / botrana
penser ha moth flight mg = 60
BASF g/ha

France RAK 2 Extra


/ BASF

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Spain Quant LBR/ F Lobesia VP 500 250 –500 Before begin 1 n. a. n. a. n. a. 250 – n. a.
BASF botrana mg/dis dispenser/ of 1.st 500
penser ha generation dispense
(+ 800 moth flight r x 500
RAK 2R / mg mg =
Hellas
Citral) 125 -
(Greece) BASF
250 g/ha

Grape Germany RAK 1+2


BRD /
BASF

RAK 1+2 140 Before begin


500
Cochylis + mg of 1.st
500 dispense
France Eudemis / Lobesia BAS generation
F VP dispenser/ 1 n. a. n. a. n. a. r x 140
BASF botrana 288 moth flight of
ha mg = 70
I/dispe 1.st species
g/ha
RAK 1+2 / nser occuring
n. a.
BASF

Italy

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape France RAK 1+2, 3


generations /
BASF
240 Before begin
500
Switzer mg of 1.st
500 dispense
land RAK 1+2 / Lobesia BAS generation
F VP dispenser/ 1 n. a. n. a. n. a. r x n. a.
BASF botrana 288 moth of 1.st
ha 240mg =
I/dispe occurring
120 g/ha
nser species

Grape Italy CHECKMAT F Lobesia CSL 25g 25 g/ha Before the 1st 3 30 n. a n. a. 25g/ha x n.a.
Spain E botrana VS generation of 3
France LB-F / the moth applicati
Germa Suterra ons =
ny (Consep 75g/ha
Greece GmbH)
(All
Field
Trials)

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Switzer CHECKMAT F Lobesia CSL 12.5g 12.5 g/ha Before the 1st 2-4 14 days for n. a. n. a. 12.5 x 6 n.a.
land E botrana VS and (1st generation of 1st applicati
(Field LB-F / 25g generatio the moth Generation ons
Trial) Suterra n and (every 2
(Consep heavy 30 days for weeks) =
GmbH) rain) normal use 75g/ha

25g/ha 25 x 3
(normal applicati
use) ons
(every 4
weeks) =
75 g/ha

Peach AT Pheromone F Cydia molesta VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
Nectarine ES dispenser / mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
st
IT r) in Funnel 1 species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Peach AT Pheromone F Cydia molesta VP 10 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
Nectarine ES dispenser / mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg =
IT r) in Delta 1st species 100-120
NL trap occurring mg/ha
UK

Grape AT Pheromone F Lobesia VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES dispenser / botrana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg =
IT r) in Funnel 1st species 10-12
NL trap occurring mg /ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape AT XLure F Lobesia VP 2 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES dispenser / botrana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 2
GE (SiberHegne dispenser moth flight of mg = 20-
IT r) in Funnel 1st species 24
NL trap occurring mg/ha
UK

Grape AT Pheromone F Lobesia VP 10 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


ES dispenser / botrana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 10
GE (SiberHegne dispenser moth flight of mg =
IT r) in Delta 1st species 100-120
NL trap occurring mg/ha
UK

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Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Italy ECODIAN® F Lobesia VP 10mg/ 2000- Before the 1st 2 60 days n. a. n. a. 2000 - n.a.
LB / Isagro botrana dispen 2500 generation of 2500
ser dispenser the moth dispense
s/ha rs/ha x
10mg
=20g-
25g

Grape Italy ECODIAN® F Lobesia VP 10mg/ 2000- Before the 1st 2 60 days n. a. n. a. 2000 - n.a.
GRAPE / botrana dispen 2500 generation of 2500
Isagro ser dispenser the moth dispense
s/ha rs/ha x
10mg
=20g-
25g

EFSA Journal 2014;12(1):3524 254


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Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Vine Spain Lobesia F Lobesia VP (1) (1) Before begin 1 n. a. n. a. n. a. (1) n. a. Active Ingredient
(Grape) botrana sex botrana of 1.st Supplier Only
pheromone / generation
SEDQ moth flight of
1.st species
occurring

Grape Italy ISONET L / F Lobesia VP 172 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Spain Shin Etsu botrana mg dispenser/ of 1.st dispense
Portug (CBC- /dispe ha generation r x 172
al Europe) nser moth flight of mg = 86
1.st species g/ha
occurring

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Grape Italy ISONET LE F Lobesia VP ?? mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Spain / botrana /dispe dispenser/ of 1.st dispense
Portug Shin Etsu nser ha generation r x ??
al (CBC- (?% moth flight of mg = ??
Europe) a.i. = 1.st species g/ha
?mg) occurring (??% a.i.
= 500
dispense
r x ??mg
=
??g/ha)

Grape Italy ISONET L F Lobesia VP ?? mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Spain PLUS / botrana /dispe dispenser/ of 1.st dispense
Portug Shin Etsu nser ha generation r x ??
al (CBC- (?% moth flight of mg = ??
Europe) a.i. = 1.st species g/ha
?mg) occurring (??% a.i.
= 500
dispense
r x ?? =
??g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.
Open

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E,Z)-7,9-dodecadien-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (E,Z)-7,9-dodecadien-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

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Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
mammalian cells

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)


Regular medical checks of manufacturing plant
personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser / No data available


Microcapsule suspension, spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

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Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
26
RMS/peer review proposal
Substance classified: (E,Z)-7,9-dodecadien-1- Xi ―Irritant‖
yl acetate R38 ―Irritating to skin‖

26
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser and spray application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser and spray application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E,Z)-7,9-dodecadien-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish E,Z-7,9-Dodecadien-1-yl 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) acetate (static)
Aquatic invertebrates E,Z-7,9-Dodecadien-1-yl 48 hr
EC50 0.38 mm
(Daphnia magna) acetate (static)
Algae E,Z-7,9-Dodecadien-1-yl 72 hr EbC50 0.45 n
(Pseudokirchneriella subcapitata) acetate (static) ErC50 1.2 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP

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Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data submitted
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
Not required

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E,Z)-7,9-dodecadien-1-yl acetate
water (E,Z)-7,9-dodecadien-1-yl acetate
sediment (E,Z)-7,9-dodecadien-1-yl acetate

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groundwater (E,Z)-7,9-dodecadien-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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7 (E)-11-Tetradecenyl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ (no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E)-11-tetradecen-1-yl acetate


Chemical name (CA) ‡ (E)-11-tetradecen-1-ol acetate
CIPAC No ‡ 868
CAS No ‡ 33189-72-9
EC No (EINECS or ELINCS) ‡ 251-401-4
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H30O2
Molecular mass ‡ 254.413 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 114-117°C/130Pa
Purity not stated
Reference required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Light transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 0.078-0.49Pa (20°C)
purity) ‡ Purity not stated
Reference required
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state >0.004g/l
purity and pH) ‡ Purity, pH and temperature not stated
Reference required
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Soluble in n-hexane, cyclohexane, benzene,
(state temperature, state purity) toluene, methylene chloride, chloroform, ethyl ether,
acetonitrile, THF, acetone, DMF, etc. Insoluble in
DMSO and ethylene glycol
Purity and temperature not stated
Reference required
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
The study for Z-8-dodecenyl acetate can be regarded as
Partition co-efficient ‡
representative.
(state temperature, pH and purity)
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s

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Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Flash point: 164°C (purity and reference not
stated)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((E)-11-Tetradecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Corn Italy ISONET-ON F Ostrinia VP 400mg 400dispen Before begin 1 n. a. n. a. n. a. 400 n. a.


/ nubilalis /dispe ser/ha of 1.st dispense
Shin Etsu nser generation r x
(CBC- (50% moth flight of 400mg =
Europe) a.i. 1.st species 160g/ha
=200 occurring (50% a.i.
mg) = 400
dispense
r
x200mg
=80g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E)-11-tetradecen-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (E)-11-tetradecen-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound

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levels could be retrieved, a data gap has been


identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
27
RMS/peer review proposal
Substance classified: (E)-11-tetradecen-1-yl Xi ―Irritant‖
acetate R38 ―Irritating to skin‖

27
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2).
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E)-11-tetradecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E)-11-tetradecen-1-yl acetate
water (E)-11-tetradecen-1-yl acetate
sediment (E)-11-tetradecen-1-yl acetate
groundwater (E)-11-tetradecen-1-yl acetate

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Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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8 (Z)-9-Tetradecenyl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-9-tetradecen-1-yl acetate


Chemical name (CA) ‡ (Z)-9-tetradecen-1-ol acetate
CIPAC No ‡ 882
CAS No ‡ 16725-53-4
EC No (EINECS or ELINCS) ‡ 240-780-1
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H30O2
Molecular mass ‡ 254.413 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ 81% purity


12-14°C
Reference required
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 116-118°C/130Pa
80% purity
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ light yellow transparent oily liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 3.47 x 10-2 mmHg (20°C)
purity) ‡ 80% purity
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state Blend: >92% purity(Z9-14:Ac: 81% purity, Z11-
purity and pH) ‡ 14:Ac: 14% purity)
insoluble in water <0.002g/l
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Blend: >92% purity(Z9-14:Ac: 81% purity, Z11-
(state temperature, state purity) 14:Ac: 14% purity)
Soluble in most organic solvents except ethylene
glycol and DMSO
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
The study for Z-8-dodecenyl acetate can be regarded as
Partition co-efficient ‡
representative.
(state temperature, pH and purity)
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ UV Visible Spectrum
(state purity, pH) 45454.55 cm -1 mol-1
(220 nm) @ 0.1wt%
92% purity
Open for applicability of data to all the SCLP‘s

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Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Flash point: 130°C (purity and reference not
stated)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((Z)-9-Tetradecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Pome Fruit Southe Shin-Etsu F Biting insects VP 240 Manual Prior to moth 1 n. a. n. a. n. a. 240 g/ha n. a.
(Apple, rn (CBC Cydia mg distribu- emergence of
pear, Europe Europe) pomonella, (total tion of 1st pest (1000
quince); (Italy) ISOMATE Adoxophyes of 5
1000 generation or dispense
Stone Fruit CLR orana, as) / dispen- prior to first r x 240
(Peach,nec Pandemis dispen sers per moth mg)
ta-rine, heparana ser ha; emergence of
apricot, (see uniform any other
plum); level 1distribu- generation
Tree nuts table tion
(Walnut) 1.5.3.1through-
1) out
orchards
Apple AT Pheromone F Adoxophyes VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
Pear ES dispenser / orana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Vegetables AT Pheromone F Agrotis VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / exclamationis mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Apple AT Pheromone F Pandemis VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Pear ES dispenser / heparana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Vegetables AT Pheromone F Spodoptera VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / exigua mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Open


and LOQ)

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-9-tetradecen-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-9-tetradecen-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 5000 mg/kg bw
Rat LC50 inhalation ‡ > 5.29 mg/L air/4 h whole body exposure
Skin irritation ‡ Non irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria,
and based on bridging in vitro gene
mutation assays in mammalian cells: (E/Z)-
8-dodecen-1-yl acetate, (Z)-9-dodecen-1-yl
acetate, (E,Z)-7,9-dodecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided

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Relevant NOAEL ‡ No data provided


Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

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Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
28
RMS/peer review proposal
Substance classified: (Z)-9-tetradecen-1-yl None
acetate

28
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-9-tetradecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-9-tetradecen-1-yl acetate
water (Z)-9-tetradecen-1-yl acetate
sediment (Z)-9-tetradecen-1-yl acetate
groundwater (Z)-9-tetradecen-1-yl acetate

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Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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9 (Z)-11-Tetradecenyl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-11-tetradecen-1-yl acetate


Chemical name (CA) ‡ (Z)-11-tetradecen-1-ol acetate
CIPAC No ‡ 876
CAS No ‡ 20711-10-8
EC No (EINECS or ELINCS) ‡ 243-982-8
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H30O2
Molecular mass ‡ 254.413 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Z9-14:Ac: 81% purity


Z11-14Ac: 14% purity
Blend: >92%
12-14°C
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Z9-14:Ac: 81% purity
Z11-14Ac: 14% purity
Blend: >92%
110-134°C/ 2mmHg
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ light yellow transparent oily liquid
Z9-14:Ac: 81% purity
Z11-14Ac: 14% purity
Blend: >92%
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 96.4% purity
purity) ‡ 1.6E-2 Pa (20°C)
2.9E-1 Pa (25°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ H = 0.031 kPa m3/mol
Blend: >92%
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 94.0%
purity and pH) ‡ ≈ 0.13 mg/l in pure water
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 94.0%
(state temperature, state purity) Solubilities at 20°C

Open for applicability of data to all the SCLP‘s


Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s

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Partition co-efficient ‡ 96.4%


(state temperature, pH and purity)

Open for applicability of data to all the SCLP‘s


Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ UV Visible Spectrum/ cm-1 mol-1
(state purity, pH) 48780.49 cm-1
(205nm)
92% purity
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 150°C (80% purity)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((Z)-11-Tetradecenyl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country /Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Apple Netherl RAK 4 / F Adoxophyes VP No 500 Before begin 1 n. a. n. a. n. a. No n. a.


ands BASF orana produc dispenser/ of 1.st producti
tion ha generation on
moth flight

Apple Italy RAK 3+4 / F Adoxophys VP 225 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
BASF Orana mg dispenser/ of 1.st dispense
BAS ha generation r x 225
280 moth flight of mg =
I/dispe 1.st species 112.5
nser occurring g/ha

Apple Netherl RAK 3+4 / F Adoxophys VP 155 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
ands BASF Orana mg dispenser/ of 1.st dispense
BAS ha generation r x 155
280 moth flight of mg =
I/dispe 1.st species 77.5
nser occurring g/ha

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country /Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple AT Pheromone F Adoxophyes VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Pear ES dispenser / orana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Apple AT Pheromone F Archips VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Pear ES dispenser / rosanus mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Ornamenta AT Pheromone F Cacoecimorph VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ls ES dispenser / a pronubana mg/dis dispenser/ of 1st generatio dispense
Organe FR DKSH penser ha, generation n r/ha x 1
Sweet GE (SiberHegne dispenser moth flight of mg = 10-
fruits IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country /Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Corn AT Pheromone F Heliothis zea VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
ES dispenser / mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Corn AT Pheromone F Ostrinia VP 1 10-12 Before begin 1 per n. a. N .a. n. a. 10-12 n.a.
ES dispenser nubilalis mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Apple AT Pheromone F Pandemis VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Pear ES dispenser / heparana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name G Group of Formulation Application Application rate per treatment (days)
Country /Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome Fruit Southe Shin-Etsu F Biting insects VP 240 Manual Prior to moth 1 n. a. n. a. n. a. 240 g/ha n. a.
(Apple, rn (CBC Cydia mg distribu- emergence of
pear, Europe Europe) pomonella, (total tion of 1st pest (1000
quince); (Italy) ISOMATE Adoxophyes of 5 1000 generation or dispense
Stone Fruit CLR orana, as) / dispen- prior to first r x 240
(Peach,nec not listed in Pandemis dispen sers per moth mg)
ta-rine, D1 for this heparana ser ha; emergence of
apricot, compound (see uniform any other
plum); level 1 distribu- generation
Tree nuts table tion
(Walnut) 1.5.3.1 through-
1) out
orchards

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-11-tetradecen-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-11-tetradecen-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 5000 mg/kg bw
Rat LC50 inhalation ‡ > 5.3 mg/L air/4 h. whole-body exposure
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria,
and based on bridging in vitro gene
mutation assays in mammalian cells: (E/Z)-

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8-dodecen-1-yl acetate, (Z)-9-dodecen-1-yl


acetate, (E,Z)-7,9-dodecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)


Acute neurotoxicity ‡ No data provided
Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

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Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
29
RMS/peer review proposal
Substance classified (Z)-11-tetradecen-1-yl None
acetate

29
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
.
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air calculated according to Atkinson (24 h day, Hydroxyl
5 -3
concentration 5 x10 cm ): T1/2 = 4.89 hrs

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-11-tetradecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER
insectivorous bird) Trigger
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-11-tetradecen-1-yl acetate

water (Z)-11-tetradecen-1-yl acetate

sediment (Z)-11-tetradecen-1-yl acetate

groundwater (Z)-11-tetradecen-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)

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Lepidopteran Pheromones

RMS/EPCO proposal

Active substance R51/53

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Lepidopteran Pheromones

10 (9Z, 12E)-Tetradecadien-1-yl acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z, E)-9, 12-tetradecadien-1-yl acetate


Chemical name (CA) ‡ (Z, E)-9, 12-tetradecadien-1-ol acetate
CIPAC No ‡ 867
CAS No ‡ 31654-77-0
EC No (EINECS or ELINCS) ‡ 250-753-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H28O2
Molecular mass ‡ 252.397 g/mol
Structural formula ‡ O

O CH3

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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 140°C/0.5mmHg
, reference required
93% (Z,E isomer)
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Colourless liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state The study for Z-8-dodecenyl acetate can be
purity) ‡ regarded as representative.
Open for applicability of data to all the SCLP‟s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 80-100% soluble
(state temperature, state purity) whole SCLP acetate group
80-99%purity.
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ The study for Z-8-dodecenyl acetate can be
(state temperature, pH and purity) regarded as representative.
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s

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Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Flash point: >110°C
No purity, no reference stated.
Reference required
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((9Z, 12E)-Tetradecadien-1-yl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Sugar Spain CHECKMAT F Spodoptera CS 74.59- 74.59- Before the 1st 3 Per crop n. a. n. a. 74.59- n.a.
beet, (Field E BAW-F / exigua LVS 595.2 595.2 generation of cycle 595.2
parsley, Trials) Suterra ml/CS ml/ha the moth ml/ha X
parsnip, (Consep 3
and other GmbH) applicati
root tuber ons =
vegetables 0.224-
; celery, 1.79 l/ha
head
lettuce, leaf
lettuce,
spinach
and other
leafy
vegetables
; broccoli,
Brussels
sprouts,
cabbage,
cauliflower
and other
cole crops;
tomato,
bell
pepper,
chilli
pepper,
sweet
pepper,
tomatillo,
and other
fruiting
vegetables
; cotton;
alfalfa; and
other crops
EFSA Journal 2014;12(1):3524
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BAW is a
pest
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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Vegetables AT Pheromone F Spodoptera VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / exigua mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Vegetables AT Pheromone F Spodoptera VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / littoralis mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
st
IT r) in Funnel 1 species 12
NL trap occurring mg/ha
UK

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z, E)-9, 12-tetradecadien-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (Z, E)-9, 12-tetradecadien-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP) / Microencapsulated vapour releasing
system, spray application

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Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
30
RMS/peer review proposal
Substance classified (Z, E)-9, 12- Xi ―Irritant‖
tetradecadien-1-yl acetate R38 ―Irritating to skin‖

30
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser and spray application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser and spray application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z, E)-9, 12-tetradecadien-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided
Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)
Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z, E)-9, 12-tetradecadien-1-yl acetate
water (Z, E)-9, 12-tetradecadien-1-yl acetate
sediment (Z, E)-9, 12-tetradecadien-1-yl acetate

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groundwater (Z, E)-9, 12-tetradecadien-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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Lepidopteran Pheromones

11 (Z)-11-Hexadecen-1-yl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ Z-11-hexadecen-1-yl acetate


Chemical name (CA) ‡ Z-11-hexadecen-1-ol acetate
CIPAC No ‡ 874
CAS No ‡ 34010-21-4
EC No (EINECS or ELINCS) ‡ 251-791-6-
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C18H34O2
Molecular mass ‡ 282.467 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Blend purity 92.5%
(blend ratio Z11-16Ac/Z-11-16Al, 0.83:1.07)
120-132°C/0.3mmHg
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Blend purity 92.5%
(blend ratio Z11-16Ac/Z-11-16Al, 0.83:1.07)
Colourless or light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state Blend purity 92.5%
purity) ‡ (blend ratio Z11-16Ac/Z-11-16Al, 0.83:1.07)
1.2 x 10-3 – 6 x 10-5 mmHg (20°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Blend purity 92.5%
(state temperature, state purity) (blend ratio Z11-16Ac/Z-11-16Al, 0.83:1.07)
Soluble in n-hexane, cyclohexane, benzene,
toluene, methylene chloride, carbon tetrachloride,
chloroform, acetonitrile, THF, acetone, DMF,
methanol, ethanol, ethyl ether. Insoluble in DMSO,
ethylene glycol
Reference required
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ The study for Z-8-dodecenyl acetate can be
(state temperature, pH and purity) regarded as representative.
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s

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Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization


can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 152°C
Blend purity 92.5%
(blend ratio Z11-16Ac/Z-11-16Al, 0.83:1.07)
Reference required
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((Z)-11-Hexadecen-1-yl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Sugar beet, Spain CHECKMAT F Spodoptera CSL 74.59- 74.59- Before the 1st 3 Per crop n. a. n. a. 74.59- n.a.
parsley, (Field E BAW-F / exigua VS 595.2 595.2 generation of cycle 595.2
parsnip, and Trials) Suterra ml/CS ml/ha the moth ml/ha X
other root tuber (Consep 3
vegetables; GmbH) applicati
celery, head ons =
lettuce, leaf 0.224-
lettuce, 1.79 l/ha
spinach and
other leafy
vegetables;
broccoli,
Brussels
sprouts,
cabbage,
cauliflower and
other cole
crops; tomato,
bell pepper,
chilli pepper,
sweet pepper,
tomatillo, and
other fruiting
vegetables;
cotton; alfalfa;
and other
crops where
BAW is a pest

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Vegetable Italy Konaga-con F Plutella VP 250mg 1000 Before begin 1 n. a. n. a. n. a. 1000m x n. a.


/ Shin Etsu xylostella /m m/ha of 1.st 250mg =
(CBC- (50%a generation 250g/ha
Europe) .i. = moth flight of (50% a.i.
120mg 1.st species = 1000m
) occurring x 125mg
=
125g/ha)

Garlic AT Pheromone F Acrolepiopsis VP 1 20 Before begin 1 per n. a. n. a. n. a. 20 n.a.


ES dispenser / assectella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 20
st
IT r) in Funnel 1 species mg/ha
NL trap occurring
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Cauliflower AT Pheromone F Mamestra VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Cabbage ES dispenser / brassicae mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Tomato AT Pheromone F Mamestra VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / oleracea mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

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Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Cabagge AT Pheromone F Plutella VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Vegetables ES dispenser / xylostella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ Z-11-hexadecen-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ Z-11-hexadecen-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP) / Microencapsulated vapour releasing
system, spray application

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Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
31
RMS/peer review proposal
Substance classified: Z-11-hexadecen-1-yl Xi ―Irritant‖
acetate R38 ―Irritating to skin‖

31
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

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Lepidopteran Pheromones

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser and spray application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser and spray application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment Z-11-hexadecen-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil Z-11-hexadecen-1-yl acetate
water Z-11-hexadecen-1-yl acetate

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sediment Z-11-hexadecen-1-yl acetate


groundwater Z-11-hexadecen-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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13 (7Z, 11E)-Hexadecadien-1-yl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z, E)-7, 11-hexadecadien-1-yl acetate


Chemical name (CA) ‡ (Z, E)-7, 11-hexadecadien-1-ol acetate
CIPAC No ‡ 865
CAS No ‡ 110-60-1
EC No (EINECS or ELINCS) ‡ not allocated
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C18H32O2
Molecular mass ‡ 280.451 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Blend 90%
(% of ZZ/ZE
47.4/42.7)
170-175°C/3Pa
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Blend 90%
(% of ZZ/ZE
47.4/42.7)
Light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state Blend 90%
purity) ‡ (% of ZZ/ZE
47.4/42.7)
8.0 x 10-5Pa
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state Blend 90%
purity and pH) ‡ (ratio 1:1)
0.2ppm (25°C)
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Blend 90%
(state temperature, state purity) (% of ZZ/ZE
47.4/42.7)
Soluble in hexane, pentane, benzene, toluene,
methanol, ethanol, ethyl ether, acetone, methylene
chloride, chloroform, acetonitrile, THF, DMSO,
acetic acid, etc. Insoluble in DMSO and ethylene
glycol
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s

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Partition co-efficient ‡ The study for Z-8-dodecenyl acetate can be


(state temperature, pH and purity) regarded as representative.
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 167°C
Blend 90%
(% of ZZ/ZE
47.4/42.7)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated (7Z, 11E)-Hexadecadien-1-yl Acetate


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Cotton Spain PB-ROPE L F Pectinophora VP 140mg 500dispen Before begin 1 n. a. n. a. n. a. 500dispe n. a.


/ Shin Etsu gossypiella /dispe sers/ha of 1.st nsers x
(CBC- nser generation 140mg =
Europe) (47.4 moth flight of 70g/ha
% a.i. 1.st species (47.4%
= occurring a.i. =
66.3m 1000
g) dispense
r
x66.3mg
=33.2g/h
a)
Cotton Greece PB-ROPE 7 F Pectinophora VP 72mg 1000dispe Before begin 1 n. a. n. a. n. a. 1000 n. a.
Shin Etsu gossypiella /dispe nsers/ha of 1.st dispense
(CBC- nser generation rs x
Europe) (50.6 moth flight of 72mg =
% a.i. 1.st species 72g/ha
= occurring (50.6%
36.4m a.i. =
g) 1000
dispense
r
x36.4mg
=36.4g/h
a)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical Residue definition is not set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z, E)-7, 11-hexadecadien-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (Z, E)-7, 11-hexadecadien-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)


no genotoxic potential in vitro in gene
mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser:


No reliable range of naturally occuring backgound

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levels could be retrieved, a data gap has been


identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser; No
reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
32
RMS/peer review proposal
Substance classified (Z, E)-7, 11- Xi ―Irritant‖
hexadecadien-1-yl acetate R38 ―Irritating to skin‖

32
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z, E)-7, 11-hexadecadien-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw


Dietary toxicity to birds LC50 > 5620 mg/kg feed
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g. Data point number
rate [kg Crop Time-scale TER
insectivorous bird) VI Trigger
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Data point
Application rate
Crop Route Hazard quotient number VI
[kg as/ha]
Trigger
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Data
point
Dose [g a.s./
Species Stage Test substance Endpoint Effect number
dispenser]
VI
Trigger
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Data point
Application rate
Crop Time-scale TER number VI
[kg as/ha]
Trigger
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z, E)-7, 11-hexadecadien-1-yl acetate
water (Z, E)-7, 11-hexadecadien-1-yl acetate
sediment (Z, E)-7, 11-hexadecadien-1-yl acetate

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groundwater (Z, E)-7, 11-hexadecadien-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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Lepidopteran Pheromones

14 (2E, 13Z)-Octadecadien-1-yl Acetate

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E, Z)-2, 13-octadecadien-1-yl acetate


Chemical name (CA) ‡ (E, Z)-2, 13-octadecadien-1-ol acetate
CIPAC No ‡ not allocated yet
CAS No ‡ 86252-65-5
EC No (EINECS or ELINCS) ‡ 862
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C20H36O2
Molecular mass ‡ 308.505 g/mol
Structural formula ‡ O

O CH3

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Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 190-203°C /66Pa
Purity: 82%
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 3 x 10-4Pa (20°C)
purity) ‡ Purity: 82%
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.0003 – 0.12 kPa m3/mol
whole group of SCLP actives
80-99% purity
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Soluble in hexane, pentane, benzene, toluene,
(state temperature, state purity) methanol, ethanol, ethyl ether, acetone, methylene
chloride, chloroform, acetonitrile, THF, DMSO,
acetic acid, etc. Insoluble in DMSO and ethylene
Purity not stated
Reference required
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ The study for Z-8-dodecenyl acetate can be
(state temperature, pH and purity) regarded as representative.
log P = 5.61 (25°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s

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Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Flash point: 186°C
Purity not stated
Reference required
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Summary of representative uses evaluated ((2E, 13Z)-Octadecadien-1-yl Acetate)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Apple, Spain ISONET Z / F Zeuzera VP 70mg 300 Before begin 1 n. a. n. a. n. a. 300 n. a.


Pear, Italy Shin Etsu pyrina /dispe dispenser of 1.st dispense
Olive, Portug (CBC- nser s/ha generation rs x
Hazlenut, al Europe) moth flight of 70mg =
Walnut 1.st species 21g/ha
occurring

Apple AT Pheromone F Zeuzera VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Pear ES dispenser / pyrina mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Tree 1st species 12
NL Safe, occurring mg/ha
UK Delta trap

Apple AT Pheromone F Zeuzera VP 10 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


Pear ES dispenser / pyrina mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 10
GE (SiberHegne dispenser moth flight of mg =
IT r) in Tree 1st species 100-120
NL Safe, occurring mg/ha
UK Delta trap

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)

Rate and extent of oral absorption ‡ No data provided


Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E, Z)-2, 13-octadecadien-1-yl acetate
(animals and plants)
Toxicologically relevant compounds ‡ (E, Z)-2, 13-octadecadien-1-yl acetate
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
acetates:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
acetates:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP
acetate:
(Z)-9-tetradecen-1-yl acetate, (Z)-11-
tetradecen-1-yl acetate, (Z,Z)-7,11-
hexadecadien-1-yl acetate, (Z,E)-7,11-
hexadecadien-1-yl acetate
Skin irritation ‡ Irritant R38
based on bridging from other SCLP
acetate, and taking into consideration the
worst case results: (E,Z)-7,9-dodecadien-1-
yl acetate
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-

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dodecen-1-yl acetate, (E,Z)-7,9-


dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate
Skin sensitisation ‡ Non-sensitiser (M&K Maximisation test)
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z,Z)-7,11-hexadecadien-1-yl
acetate, (Z,E)-7,11-hexadecadien-1-yl
acetate

Short term toxicity (Annex IIA, point 5.3)


Target / critical effect ‡ No data provided
Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
mammalian cells,
based on bridging from other SCLP
acetate:
(E/Z)-8-dodecen-1-yl acetate, (Z)-9-
dodecen-1-yl acetate, (E,Z)-7,9-
dodecadien-1-yl acetate, (Z)-9-tetradecen-
1-yl acetate, (Z)-11-tetradecen-1-yl acetate,
(Z,Z)-7,11-hexadecadien-1-yl acetate,
(Z,E)-7,11-hexadecadien-1-yl acetate

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided

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Relevant parental NOAEL ‡ No data provided


Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound

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levels could be retrieved, a data gap has been


identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
33
RMS/peer review proposal
Substance classified: (E, Z)-2, 13- Xi ―Irritant‖
octadecadien-1-yl acetate R38 ―Irritating to skin‖

33
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E, Z)-2, 13-octadecadien-1-yl acetate

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Acetates)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Acetates)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Acetates)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]

Laboratory tests
Fish Based on lowest endpoint of 96 hr
LC50 6.35 mm
(Oncorhynchus mykiss) SCLP Acetates (static)
Aquatic invertebrates Based on lowest endpoint of 48 hr
EC50 0.38 mm
(Daphnia magna) SCLP Acetates (static)
Algae Based on lowest endpoint of 72 hr EbC50 0.3 n
(Pseudokirchneriella subcapitata) SCLP Acetates (static) ErC50 1.3 n
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data available


Acute contact toxicity Limited toxic effects observed (Based study performed with SCLP
Acetates)
Inhalation toxicity (72 hour) Limited toxic effects observed (Based study performed with SCLP
Acetates)

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Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Data
point
Dose [g a.s./
Species Stage Test substance Endpoint Effect number
dispenser]
VI
Trigger
Laboratory tests
Corrected
- 19%
Based study Mortality
Chrysoperla
Adults performed with 0.264 50%
carnea Oviposition 8.5%
SCLP Acetates
Larval Hatching - 7.1%
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Data point
Application rate
Crop Time-scale TER number VI
[kg as/ha]
Trigger
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E, Z)-2, 13-octadecadien-1-yl acetate
water (E, Z)-2, 13-octadecadien-1-yl acetate
sediment (E, Z)-2, 13-octadecadien-1-yl acetate

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groundwater (E, Z)-2, 13-octadecadien-1-yl acetate

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R51/53

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General comment: Where appropriate, the lists of endpoints were modified according to the format for
the listing of endpoints proposed in appendix 9 of the OECD Series on Pesticides (Number 12):
Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for
Arthropod Pest Control ENV/JM/MONO(2001)12.

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16 E-5-Decenol
Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ No ISO common name


Function (e.g. fungicide) Semio-chemicals

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E)-5-decen-1-ol


Chemical name (CA) ‡ (E)-5-decenol
CIPAC No ‡ 869
CAS No ‡ 56578-18-8
EC No (EINECS or ELINCS) ‡ 260-267-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C10H20O
Molecular mass ‡ 156.269 g/mol
Structural formula ‡ OH

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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 226-230°C
blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ colourless liquid
blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state E5-10:Ac = 1.085 Pa (20°C)
purity) ‡ E5-10OH = 1.364 Pa (20°C)
blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s
3
Henry‘s law constant ‡ 0.100 - 0.0003 kPa m /mol
Range bridged from E,E-8,10-dodecadienol
(80-99% purity)
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 0.138 g/l (20°C)
purity and pH) ‡ Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Easily soluble in common organic solvent, no
(state temperature, state purity) precipitate generated
blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives 80-99% purity
purity)
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ 4.95 (20°C)
(state temperature, pH and purity) blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
-1 -1
UV/VIS absorption (max.) incl. ‡ 5.38 [cm mol L (580nm)]
(state purity, pH) blend: 98.6% purity (E5-10:Ac = 84.2%, E5-10OH =
14.4%)
Open for applicability of data to all the SCLP‘s

EFSA Journal 2014;12(1):3524 387


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

EFSA Journal 2014;12(1):3524 388


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Summary of representative uses evaluated (E-5-Decenol)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max
Peach Italy RAK 5+6 / F Anarsia VP 550 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
BASF lineatella mg dispenser/ of 1.st dispense
/dispe ha generation r x 500
nser moth flight of mg =
1.st species 250 g/ha
occurring

Peach, Italy ISONET A / F Anarsia VP 160 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Nectarine, Spain Shin Etsu lineatella mg dispenser/ of 1.st dispense
Apricot, Portug (CBC- /dispe ha generation r x 160
Plum al Europe) nser moth flight of mg =
(1% 1.st species 160 g/ha
a.i. = occurs (1% a.i.
1.6mg = 1000
) dispense
r x 1.6
mg = 1.6
g/ha)
VP vapour releasing product in closed dispenser
n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

EFSA Journal 2014;12(1):3524 389


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique)


Open
Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 390


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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E)-5-decen-1-ol
(animals and plants)
Toxicologically relevant compounds ‡ (E)-5-decen-1-ol
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin irritation ‡ Irritant R38
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Eye irritation ‡ Non-irritant
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin sensitisation ‡ Sensitiser (M&K Maximisation test) R43
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

EFSA Journal 2014;12(1):3524 391


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
chromosome aberration test
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity
Reproduction target / critical effect ‡ No data provided
Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

EFSA Journal 2014;12(1):3524 392


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Lepidopteran Pheromones

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)


Operator Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
34
RMS/peer review proposal

34
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

EFSA Journal 2014;12(1):3524 393


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Substance classified: (E)-5-decen-1-ol Xi ―Irritant‖


R38 ―Irritating to skin‖
R43 ―May cause sensitisation by skin contact‖

EFSA Journal 2014;12(1):3524 394


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

EFSA Journal 2014;12(1):3524 395


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

EFSA Journal 2014;12(1):3524 396


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E)-5-decen-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

EFSA Journal 2014;12(1):3524 397


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2050 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)
Dietary toxicity to birds No data provided
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Fish Based on lowest endpoint 96 hr
LC50 >0.685 mm
(Brachydanio rerio) of SCLP Alcohols (semi- static)
Aquatic invertebrates Based on lowest endpoint 48 hr
EC50 0.3 mm
(Daphnia magna) of SCLP Alcohols (static)
Algae Based on lowest endpoint 72 hr EbC50 0.074 mm
(Scenedesmus subspicatus) of SCLP Alcohols (static) ErC50 0.221 mm
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs
Alcohols)
Acute contact toxicity LD50 203.3 µg a.s./bee (based on lowest endpoint of SCLP SCLP
Alcohols)

EFSA Journal 2014;12(1):3524 398


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Species Stage Test substance Exposure Endpoint Effect Trigger
Laboratory tests

Based on 20 day No
inhalation Mortality and
Chrysoperla available data adverse
Adults behavioral 50%
carnea for SCLP 0.12 g / 3.17 effects
effects
alcohols ppm reported
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E)-5-decen-1-ol
water (E)-5-decen-1-ol
sediment (E)-5-decen-1-ol
groundwater (E)-5-decen-1-ol

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

EFSA Journal 2014;12(1):3524 399


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Active substance R50/53

EFSA Journal 2014;12(1):3524 400


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Lepidopteran Pheromones

17 (Z)-8-Dodecenol

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-8-dodecen-1-ol


Chemical name (CA) ‡ (Z)-8-dodecenol
CIPAC No ‡ 880
CAS No ‡ 40642-40-8
EC No (EINECS or ELINCS) ‡ 255-019-9
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C12H22O
Molecular mass ‡ 184.32 g/mol
Structural formula ‡ OH

EFSA Journal 2014;12(1):3524 401


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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 115-118 °C
Purity=92%
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Light yellow liquid
Purity=92%
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 1.17 Pa (20°C)
purity) ‡ Purity=92%
Open for applicability of data to all the SCLP‘s
3
Henry‘s law constant ‡ 0.100 - 0.0003 kPa m /mol
Range bridged from E,E-8,10-dodecadienol
(80-99% purity)
Open for applicability of data to all the SCLP‘s
-4
Solubility in water (state temperature, state 7.1 x 10 – 0.14 g/L (80-99% purity)
purity and pH) ‡ bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Average 80-100% soluble (80-99% purity)
(state temperature, state purity) bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives (80-99% purity)
purity)
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ The study for E,E-8,10-dodecadienol can be
(state temperature, pH and purity) regarded as representative.
mean pow log = 4.36 (21°C)
Open for applicability of data to all the SCLP‟s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 134 °C (purity not stated)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

EFSA Journal 2014;12(1):3524 402


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Lepidopteran Pheromones

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 403


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Lepidopteran Pheromones

Summary of representative uses evaluated ((Z)-8-Dodecenol)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max
Peach, Italy ISOMATE F Grapholita VP 240 250 Before begin 1 n. a. n. a. n. a. 250 n. a.
Nectarine, Spain M-100 / Shin molesta mg dispenser/ of 1.st dispense
Apricot, Portug Etsu /dispe ha generation r x 240
Plum, al (CBC- nser moth flight of mg = 60
Plum, Europe) (1% 1.st species g/ha
Apple, a.i. = occurring (1% a.i.
Pear, 2.4mg = 250
Quince ) dispense
r x
2.4mg =
0.6g/ha)
Peach, Italy ISOMATE- F Grapholita VP 240 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
Nectarine, Spain OFM Rosso molesta mg dispenser/ of 1.st dispense
Apricot, Portug / Shin Etsu /dispe ha generation r x 240
Plum, al (CBC- nser moth flight of mg =
Plum, Europe) (1% 1.st species 120 g/ha
Apple, a.i. = occurring (1% a.i.
Pear, 2.4mg = 500
Quince ) dispense
r x
2.4mg =
1.2g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

EFSA Journal 2014;12(1):3524 404


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

EFSA Journal 2014;12(1):3524 405


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Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 406


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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-8-dodecen-1-ol
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-8-dodecen-1-ol
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin irritation ‡ Irritant R38
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Eye irritation ‡ Non-irritant
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin sensitisation ‡ Sensitiser (M&K Maximisation test) R43
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

EFSA Journal 2014;12(1):3524 407


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Lepidopteran Pheromones

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
chromosome aberration test
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity
Reproduction target / critical effect ‡ No data provided
Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

EFSA Journal 2014;12(1):3524 408


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Lepidopteran Pheromones

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)


Operator Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
35
RMS/peer review proposal

35
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

EFSA Journal 2014;12(1):3524 409


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Lepidopteran Pheromones

Substance classified: (Z)-8-dodecen-1-ol Xi ―Irritant‖


R38 ―Irritating to skin‖
R43 ―May cause sensitisation by skin contact‖

EFSA Journal 2014;12(1):3524 410


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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

EFSA Journal 2014;12(1):3524 411


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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

EFSA Journal 2014;12(1):3524 412


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-8-dodecen-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

EFSA Journal 2014;12(1):3524 413


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Acute toxicity to birds
LD50 > 2050 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)
Dietary toxicity to birds
No data provided
Acute toxicity to mammals
LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Fish Based on lowest endpoint 96 hr
LC50 >0.685 mm
(Brachydanio rerio) of SCLP Alcohols (semi- static)
Aquatic invertebrates Based on lowest endpoint 48 hr
EC50 0.3 mm
(Daphnia magna) of SCLP Alcohols (static)
Algae Based on lowest endpoint 72 hr EbC50 0.074 mm
(Scenedesmus subspicatus) of SCLP Alcohols (static) ErC50 0.221 mm
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs
Alcohols)
Acute contact toxicity LD50 203.3 µg a.s./bee (based on lowest endpoint of SCLP
Alcohols)

EFSA Journal 2014;12(1):3524 414


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Species Stage Test substance Exposure Endpoint Effect Trigger
Laboratory tests

Based on 20 day No
inhalation Mortality and
Chrysoperla available data adverse
Adults behavioral 50%
carnea for SCLP 0.12 g / 3.17 effects
effects
alcohols ppm reported
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-8-dodecen-1-ol
water (Z)-8-dodecen-1-ol
sediment (Z)-8-dodecen-1-ol
groundwater (Z)-8-dodecen-1-ol

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

EFSA Journal 2014;12(1):3524 415


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Active substance R50/53

EFSA Journal 2014;12(1):3524 416


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

18 (E,E)-8,10-Dodecadien-1-ol

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (E,E)-8,10-dodecadien-1-ol


Chemical name (CA) ‡ (E,E)-8,10-dodecadienol
CIPAC No ‡ 860
CAS No ‡ 33956-49-9
EC No (EINECS or ELINCS) ‡ 251-761-2
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C12H22O
Molecular mass ‡ 182.306 g/mol
Structural formula ‡ OH

EFSA Journal 2014;12(1):3524 417


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ 30 – 32 °C


(>89.0% purity (geometric isomers <12.5%)
total blend: 99%)
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 120-122 °C (reduced pressure 267 Pa)
(>89.0% purity (geometric isomers <12.5%)
total blend: 99%)
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Solid, light yellow powder < 30-32 °C
light yellow transparent oily liquid > 30-32 °C
(>89.0% purity (geometric isomers <12.5%)
total blend: 99%)
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 0.033 Pa (20 °C) (95.2%)
purity) ‡ 0.062 Pa (25 °C)
Open for applicability of data to all the SCLP‘s
-4 3
Henry‘s law constant ‡ 2.833 x 10 kPa m /mol
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 21.2 ± 1.5mg/L (20 °C) (95.2%)Open for
purity and pH) ‡ applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 96.4%
(state temperature, state purity)

Open for applicability of data to all the SCLP‘s


Surface tension ‡ Not required*
(state concentration and temperature, state Open for applicability of data to all the SCLP‘s
purity)
mean pow log = 4.36 (21 °C) (95.2%)
pow log ≥3.32 ± 0.02 (20 °C) (99.46%)

Partition co-efficient ‡ mean pow log = 4.36 (21°C)


(state temperature, pH and purity) Open for applicability of data to all the SCLP‟s

EFSA Journal 2014;12(1):3524 418


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Lepidopteran Pheromones

Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization


can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 135 °C (79%)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 419


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Summary of representative uses evaluated ((E,E)-8,10-Dodecadien-1-ol)


Crop and/ Member Product F Pests or PHI Remarks:
or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Apple Germany RAK 3+4


Nur
Apfelwickler
/ BASF
500
Before begin dispense
225 500
Cydia of 1.st r x 225
F VP mg/dis dispenser/ 1 n. a. n. a. n. a. n. a.
Austria pomonella generation mg =
penser ha
Slovenia moth flight 112.5
Italy RAK 3 / g/ha
BASF

Apple Netherla RAK 3 NEU F Cydia VP 125mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
nds / BASF pomonella /dispe dispenser/ of 1.st dispense
nser ha generation r x 125
moth flight mg =
62.5
g/ha

EFSA Journal 2014;12(1):3524 420


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple Italy RAK 3+4 / F Cydia VP 225mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
BASF pomonella, BAS dispenser/ of 1.st dispense
285 ha generation r x 225
I,/disp moth flight of mg =
enser 1.st species 112.5
occurring g/ha

Apple Netherla RAK 3+4 / F Cydia VP 125mg 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
nds BASF pomonella, BAS dispenser/ of 1.st dispense
285 ha generation r x 125
I,/disp moth flight of mg =
enser 1.st species 62.5
occurring g/ha

EFSA Journal 2014;12(1):3524 421


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Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome fruit, Spain CHECKMA F Laspeyresia VP 180 300-400 Before the 1st 1-2 When n. a n. a 300-400 n. a
Stone fruit, TE CM-CS [Cydia] mg/dis dispenser generation of required dispense
(Known as pomonella penser s/ha the moth rs/ha x
CM) / 180 mg
Suterra = 54-72
(Consep g/ha
GmbH) X 2
applicati
ons
= 108-
144 g/ha

Tree nut Spain CHECKMA F Laspeyresia VP 180 375-500 Before the 1st 1-2 When n. a n. a 375-500 n. a
crops TE CM-CS [Cydia] mg/dis dispenser generation of required dispense
(Known as pomonella penser s/ha the moth rs/ha x
CM) / 180 mg
Suterra = 67.5-
(Consep 90 g/ha
GmbH) X 2
applicati
ons
= 135-
180 g/ha

EFSA Journal 2014;12(1):3524 422


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome fruit, German CHECKMA F Laspeyresia VP 180 300-400 Before the 1st 1-2 When n. a n. a 300-400 n. a
Stone fruit, y TE CM-CS [Cydia] mg/dis dispenser generation of required dispense
(Known as pomonella penser s/ha the moth rs/ha x
CM) / 180 mg
Suterra = 54-72
(Consep g/ha
GmbH) X 2
applicati
ons
= 108-
144 g/ha

Pome fruit, Italy CHECKMA F Laspeyresia VP 240 300 Before the 1st 1-2 When n. a n. a 300 n. a
Stone fruit, TE CM-WS [Cydia] mg/dis dispenser generation of required dispense
Tree nut / Suterra pomonella penser s/ha the moth rs/ha x
crops (Consep 240 mg
GmbH) = 72
g/ha
X 2
applicati
ons
= 144
g/ha

EFSA Journal 2014;12(1):3524 423


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome fruit, France CHECKMA F Laspeyresia VP 270 300 Before the 1st 1-2 (max) When n. a n. a 300 n. a
Stone fruit, (In TE CM-WS [Cydia] mg/dis dispenser generation of required dispense
Tree nut Review) / Suterra pomonella penser s/ha the moth rs/ha x
crops (Consep 270 mg
GmbH) = 81
g/ha
X 2
applicati
ons
= 162
g/ha

Pome fruit, Italy CHECKMA F Laspeyresia VP 180 300-400 Before the 1st 1-2 When n. a n. a 300-400 n. a
Stone fruit, (Field TE CM / [Cydia] mg/dis dispenser generation of required dispense
Tree nut Trials) Suterra pomonella penser s/ha the moth rs/ha x
crops (Consep 180 mg
GmbH) = 54-72
g/ha
X 2
applicati
ons
= 108-
144 g/ha

EFSA Journal 2014;12(1):3524 424


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome fruit, Spain CHECKMA F Laspeyresia VP 270 500 Before the 1st 1 When n. a n. a 500 n.a
Stone fruit, Germany TE CM- [Cydia] mg/dis dispenser generation of required dispense
Tree nut (All Field XL1000 / pomonella penser s/ha the moth rs/ha x
crops Trials) Suterra 270 mg
(Consep = 135
GmbH) g/ha

Pome fruit Southern Suterra F Biting insects CSL 0.143 Low Prior to moth Max. 3 30 days Max. Low volume 4.1 g – n. a. 24.3 g as/ha/
(Apple, Europe (Consep Cydia VS g / ml volume emergence of 2.025 spraying 8.1 g year
pear, (Spain) GmbH) pomonella = 143 spraying 1st pest g/hl = (max. 400 l as/ha
quince), CHECKMA (Cydia g/l generation 0.002025 /ha) =
Stone fruit TE CM-F caryana – not and/or prior to kg/hl 0.0041 –
(Peach, relevant pest moth 0.0081
nectarine, in Europe) emergence of kg as/ha
plum, Tree any other
nuts generation
(Walnuts)
Pome fruit Northern Suterra F Biting insects CSL 0.143 Low Prior to moth 3 30 days Max. Low volume 4.1 g – n. a. 24.3 g as/ha/
(Apple, Europe (Consep Cydia VS g / ml volume emergence of 2.025 spraying 8.1 g year
pear, (no GmbH) pomonella = 143 spraying 1st pest g/hl = (max. 400 l as/ha
quince), authoriz CHECKMA (Cydia g/l generation 0.002025 /ha) =
Stone fruit ation) TE CM-F caryana – not and/or prior to kg/hl 0.0041 –
(Peach, relevant pest first moth 0.0081
nectarine, in Europe) emergence of kg as/ha
plum, Tree any other
nuts generation
(Walnuts)

EFSA Journal 2014;12(1):3524 425


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Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome fruit, Spain Puffer CM / F Laspeyresia AD 69.33 6.95 Before the 1st 1 When n. a n. a 2 n. a
Stone fruit, (Field Suterra [Cydia] g/cani mg/40 generation of required aerosol
Tree nut Trials) (Consep pomonella ster microliter the moth dispense
crops GmbH) puff rs/ha x
69.33 g
2 aerosol = 138.7
dispenser g/ha
s/ha

Chestnut AT Pheromone F Cydia VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / fagiglandana mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegn dispenser moth flight of mg = 10-
IT er) in Funnel 1st species 12
NL trap occurring mg/ha
UK

EFSA Journal 2014;12(1):3524 426


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple AT Pheromone F Cydia VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


Pear ES dispenser / pomonella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegn dispenser moth flight of mg =
IT er) in Funnel 1st species 10-12
NL trap occurring mg /ha
UK

Apple AT XLure F Cydia VP 2 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


Pear ES dispenser / pomonella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 2
GE (SiberHegn dispenser moth flight of mg = 20-
IT er) in Funnel 1st species 24
NL trap occurring mg/ha
UK

EFSA Journal 2014;12(1):3524 427


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple AT Pheromone F Cydia VP 10 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n. a.


Pear ES dispenser / pomonella mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 10
GE (SiberHegn dispenser moth flight of mg =
IT er) in Delta 1st species 100-120
NL trap occurring mg/ha
UK

Apple Italy ECODIAN® F Cydia VP 13mg/ 2000- Before the 1st 2 60-70 days n .a. n. a. 2000- n .a.
Pear France CP / Pomonella dispen 3000 generation of 3000
Walnut Portugal Isagro ser dispenser the moth dispense
Austria s/ha (low- rs/ha x
high 10mg
density =26g-
pest) 39g/ha

EFSA Journal 2014;12(1):3524 428


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple, Spain Cydia F Laspeyresia VP (1) (1) Before begin 1 n. a. n. a. n. a. (1) n. a.


Pear, pomonella Cydia) of 1.st
Peach, sex (pomonella generation
Walnut pheromone (1) moth flight of
/ 1.st species
SEDQ occurs

Apple, Spain ISOMATE F Laspeyresia VP 190 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Pear, Italy C PLUS (Cydia) mg dispenser/ of 1.st dispense
Walnut, France (Spain, pomonella /dispe ha generation r x
Quince Portugal Italy, nser moth flight of 190mg =
Portugal), (50% 1.st species 190g/ha
ISOMATE- a.i. occurring (50% a.i.
C(France) / =95m = 1000
Shin Etsu g) dispense
(CBC- r x95mg
Europe ) =95g/ha)

EFSA Journal 2014;12(1):3524 429


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple, Spain ISOMATE F Laspeyresia VP 380 500 Before begin 1 n. a. n. a. n. a. 500 n. a.


Pear, Italy C TT (Cydia) mg dispenser/ of 1.st dispense
Walnut, France (Spain, pomonella /dispe ha generation r x
Quince Portugal Italy, nser moth flight of 380mg =
Portugal), (50% 1.st species 190g/ha
GINKO(Fra a.i. = occurring (50% a.i.
nce) / 190mg = 500
Shin Etsu ) dispense
(CBC- r x
Europe) 190mg
=95g/ha)

Pome Southern Shin-Etsu F Biting insects VP 240 Manual Prior to moth 1 n. a. n. a. n. a. 240 g/ha n. a.
Fruit Europe (CBC Cydia mg distribu- emergence of
(Apple, (Italy) Europe) pomonella, (total tion of 1st pest (1000
pear, ISOMATE Adoxophyes of 5 1000 generation or dispense
quince); CLR orana, as) / dispen- prior to first r x 240
Stone Pandemis dispen sers per moth mg)
Fruit heparana ser ha; emergence of
(Peach,ne (see uniform any other
cta-rine, level 1 distribu- generation
apricot, table tion
plum); 1.5.3.1 through-
Tree nuts 1) out
(Walnut) orchards

EFSA Journal 2014;12(1):3524 430


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or State or name / G Group of Formulation Application Application rate per treatment (days)
situation Country Company or pests
I controlled
(b) (l) (m)
(a) (c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple, Italy ISOMATE F Laspeyresia VP 340 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Pear, C LR PLUS (Cydia) mg dispenser/ of 1.st dispense
Walnut, / Shin Etsu pomonella /dispe ha generation r x
Quince (CBC- nser moth flight of 340mg =
Europe) (42% 1.st species 340g/ha
a.i. occurring (42% a.i.
=145 = 1000
mg) dispense
r
x145mg
=
145g/ha)
Apple, Italy ISOMATE F Laspeyresia VP 210mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.
Pear, C OFM / (Cydia) /dispe dispenser/ of 1.st dispense
Walnut, Shin Etsu pomonella nser ha generation r
Quince (CBC- (68% moth flight of x210mg
Europe) a.i. = 1.st species =
143mg occurring 210g/ha
) (68% a.i.
= 1000
dispense
r x
143mg =
143g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules
CS capsule suspension
LVS low volume spraying
n.a. not applicable
Reason for greying out: Spray Application not supported by complete data package

EFSA Journal 2014;12(1):3524 431


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

EFSA Journal 2014;12(1):3524 432


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set

Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 433


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (E,E)-8,10-dodecadien-1-ol
(animals and plants)
Toxicologically relevant compounds ‡ (E,E)-8,10-dodecadien-1-ol
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
Skin irritation ‡ Irritant R38
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Sensitiser (Magnusson & Kligman) R43

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ Rat:


Males: stomach / erosion of glandular mucosa,
kidney / tubular dilatation and vacuolation
Females: no adverse effect up to the limit dose
Relevant oral NOAEL ‡ 28-day, rat: LOAEL 1000 mg/kg bw per day
(males)
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
chromosome aberration test

EFSA Journal 2014;12(1):3524 434


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity
Reproduction target / critical effect ‡ No data provided
Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated

EFSA Journal 2014;12(1):3524 435


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

ARfD ‡ Not allocated for derivation of


reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available


(VP) / Microencapsulated vapour releasing
system, spray application

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP)


and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
operators is required, to be compared with natural
background levels.
Workers Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
workers is required, to be compared with natural
background levels.
Bystanders Vapour releasing product in closed dispenser (VP)
and microcapsule suspension, spray application:
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.
Microcapsule suspension, spray application:
data gap: a realistic exposure assessment for the
bystanders is required, to be compared with natural
background levels.

EFSA Journal 2014;12(1):3524 436


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
36
RMS/peer review proposal
Substance classified: (E,E)-8,10-dodecadien- Xi ―Irritant‖
1-ol R38 ―Irritating to skin‖
R43 ―May cause sensitisation by skin contact‖

36
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

EFSA Journal 2014;12(1):3524 437


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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
-For the intended use of the active substance SCLPs emitted via volatilisation from closed retrievable
dispensers, a data gap is set to address the natural background levels and to demonstrate that these are
not exceeded when using the SCLPs as a plant protection product according to the use pattern.
-For the low volume spray application of microencapsulated SCLPs, a data gap is set to provide a
sufficient residue data package in order to conduct a reliable consumer dietary risk assessment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open


Spray application: not fully established

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open


Spray application: not fully established

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open


Spray application: not fully established

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open


Spray application: not fully established
Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open


Spray application: not fully established

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites Spray application: not fully established

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

EFSA Journal 2014;12(1):3524 439


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open


Spray application: no risk assessment submitted

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required


Spray application: no risk assessment submitted

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser and spray application: open

Photochemical oxidative degradation in air: Calculation according to Atkinson (24h day, hydroxyl
5 -3
concentration 5 x10 cm ): T1/2 = 2.75 hrs

PEC (air) (Annex IIIA, point 9.3)

Dispenser and spray application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (E,E)-8,10-Dodecadien-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open


Spray application: not fully established

EFSA Journal 2014;12(1):3524 440


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2050 mg/kg bw


Dietary toxicity to birds No data provided
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Fish 96 hr
E,E-8,10-Dodecadien-1-ol LC50 >0.685 mm
(Brachydanio rerio) (semi- static)
Aquatic invertebrates 48 hr
E,E-8,10-Dodecadien-1-ol EC50 0.3 mm
(Daphnia magna) (static)
Algae 72 hr EbC50 0.074 mm
E,E-8,10-Dodecadien-1-ol
(Scenedesmus subspicatus) (static) ErC50 0.221 mm
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs
Alcohols)
Acute contact toxicity LD50 203.3 µg a.s./bee (based on lowest endpoint of SCLP
Alcohols)

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Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient rigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Species Stage Test substance Exposure Endpoint Effect Trigger
Laboratory tests

Based on 20 day No
inhalation Mortality and
Chrysoperla available data adverse
Adults behavioral 50%
carnea for SCLP 0.12 g / 3.17 effects
effects
alcohols ppm reported
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Dispenser application: Risk assessment open
Spray application: Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (E,E)-8,10-Dodecadien-1-ol
water (E,E)-8,10-Dodecadien-1-ol
sediment (E,E)-8,10-Dodecadien-1-ol
groundwater (E,E)-8,10-Dodecadien-1-ol

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

EFSA Journal 2014;12(1):3524 443


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Lepidopteran Pheromones

19 1-Tetradecanol
Listing of end points
Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ tetradecan-1-ol


Chemical name (CA) ‡ 1-tetradecanol
CIPAC No ‡ 856
CAS No ‡ 112-72-1
EC No (EINECS or ELINCS) ‡ 204-000-3
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H30O
Molecular mass ‡ 214.392 g/mol
Structural formula ‡ OH

EFSA Journal 2014;12(1):3524 444


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ 36-39 °C (>95%)


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 289 °C (>95%)
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Solid, white powder at room temperature (>95%)
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state The study for E,E-8,10-dodecadienol can be
purity) ‡ regarded as representative.
3.3 X 10-4 mbar or hPa (20°C) (0.033 Pa)
6.2 X 10-4 mbar or hPa (25°C) (0.062 Pa)
[3.3E-04 (20°C)
6.2E-04 (25°C)]
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ 0.100 - 0.0003 kPa m3/mol
Range bridged from E,E-8,10-dodecadienol
(80-99% purity)
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L (80-99% purity)
purity and pH) ‡ bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ soluble in methanol, THF, n-hexane, acetone,
(state temperature, state purity) DMSO, chloroform, ethylether, benzene, toluene
(>95%)
Open for applicability of data to all the SCLP‘s
Surface tension ‡ Not required*
(state concentration and temperature, state Open for applicability of data to all the SCLP‘s
purity)
Partition co-efficient ‡ log P = 5.75 (software calculation)
(state temperature, pH and purity)
The study for E,E-8,10-dodecadienol can be
regarded as representative.
mean pow log = 4.36 (21°C)
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s

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Lepidopteran Pheromones

Flammability ‡ (state purity) Not required*


Flash point: 110°C °C
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) Not required*
Oxidising properties ‡ (state purity) Not required*

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Summary of representative uses evaluated (1-Tetradecanol)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Apple, Spain ISOMATE C F Laspeyresia VP 190 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Pear, Italy PLUS (Cydia) mg dispenser/ of 1.st dispense
Walnut, France (Spain, Italy, pomonella /dispe ha generation r x
Quince Portugal Portugal), nser moth flight of 190mg =
ISOMATE- (5% 1.st species 190g/ha
C(France) / a.i. = occurring (5 % a.i.
Shin Etsu 10mg) = 1000
(CBC- dispense
Europe) r x 10mg
=
10g/ha)
Apple, Spain ISOMATE C F Laspeyresia VP 380 500 Before begin 1 n. a. n. a. n. a. 500 n. a.
Pear, Italy TT (Cydia) mg dispenser/ of 1.st dispense
Walnut, France (Spain,Italy, pomonella /dispe ha generation r x
Quince Portugal Portugal), nser moth flight of 380mg =
GINKO(Fran (5% 1.st species 190g/ha
ce) / a.i. = occurring (5% a.i.
Shin Etsu 19mg) = 500
(CBC- dispense
Europe) r x 19mg
=
10g/ha)

EFSA Journal 2014;12(1):3524 447


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Pome Fruit Southe Shin-Etsu F Biting insects VP 240 Manual Prior to moth 1 n. a. n. a. n. a. 240 g/ha n. a.
(Apple, rn (CBC Cydia mg distribu- emergence of
pear, Europe Europe) pomonella, (total tion of 1st pest (1000
quince); (Italy) ISOMATE Adoxophyes of 5
1000 generation or dispense
Stone Fruit CLR orana, as) / dispen- prior to first r x 240
(Peach,nec Pandemis dispen sers per moth mg)
ta-rine, heparana ser ha; emergence of
apricot, (see uniform any other
plum); level 1distribu- generation
Tree nuts table tion
(Walnut) 1.5.3.1through-
1) out
orchards
Apple, Italy ISOMATE C F Laspeyresia VP 340 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.
Pear, LR PLUS / (Cydia) mg dispenser/ of 1.st dispense
Walnut, Shin Etsu pomonella /dispe ha generation r x
Quince (CBC- nser moth flight of 240mg =
Europe) (1.3% 1.st species 240g/ha
a.i. = occurring (1.3%
4mg) a.i. =
1000
dispense
r x 4mg
=4g/ha)

EFSA Journal 2014;12(1):3524 448


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Apple, Italy ISOMATE C F Laspeyresia VP 210mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


Pear, OFM / (Cydia) /dispe dispenser/ of 1.st dispense
Walnut, Shin Etsu pomonella, nser ha generation r x
Quince (CBC- (2% moth flight of 210mg =
Europe) a.i. = 1.st species 210g/ha
4mg) occurring (2% a.i.
= 1000
dispense
r x 4mg
= 4g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

EFSA Journal 2014;12(1):3524 449


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 450


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ tetradecan-1-ol
(animals and plants)
Toxicologically relevant compounds ‡ tetradecan-1-ol
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin irritation ‡ Irritant R38
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Eye irritation ‡ Non-irritant
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin sensitisation ‡ Sensitiser (M&K Maximisation test) R43
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

EFSA Journal 2014;12(1):3524 451


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
chromosome aberration test
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity
Reproduction target / critical effect ‡ No data provided
Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

EFSA Journal 2014;12(1):3524 452


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)


Operator Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
37
RMS/peer review proposal

37
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

EFSA Journal 2014;12(1):3524 453


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Substance classified: tetradecan-1-ol Xi ―Irritant‖


R38 ―Irritating to skin‖
R43 ―May cause sensitisation by skin contact‖

EFSA Journal 2014;12(1):3524 454


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6).
Open.

EFSA Journal 2014;12(1):3524 455


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

EFSA Journal 2014;12(1):3524 456


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment tetradecan-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

EFSA Journal 2014;12(1):3524 457


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs). In general
the grouping is based on chemical properties (functional groups) of the SCLPs.

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2050 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)
Dietary toxicity to birds No data provided
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Fish Based on lowest endpoint 96 hr
LC50 >0.685 mm
(Brachydanio rerio) of SCLP Alcohols (semi- static)
Aquatic invertebrates Based on lowest endpoint 48 hr
EC50 0.3 mm
(Daphnia magna) of SCLP Alcohols (static)
Algae Based on lowest endpoint 72 hr EbC50 0.074 mm
(Scenedesmus subspicatus) of SCLP Alcohols (static) ErC50 0.221 mm
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs
Alcohols)
Acute contact toxicity LD50 203.3 µg a.s./bee (based on lowest endpoint of SCLP
Alcohols)

EFSA Journal 2014;12(1):3524 458


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Test
Species Stage Exposure Endpoint Effect Trigger
substance
Laboratory tests

Based on 20 day No
inhalation Mortality and
Chrysoperla available data adverse
Adults behavioral 50%
carnea for SCLP 0.12 g / 3.17 effects
effects
alcohols ppm reported
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil tetradecan-1-ol
water tetradecan-1-ol
sediment tetradecan-1-ol
groundwater tetradecan-1-ol

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)

EFSA Journal 2014;12(1):3524 459


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

RMS/EPCO proposal

Active substance R50/53

EFSA Journal 2014;12(1):3524 460


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

20 (Z)-11-Hexadecen-1-ol

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-11-hexadecen-1-ol


Chemical name (CA) ‡ Z-11-hexadecen-1-ol
CIPAC No ‡ 873
CAS No ‡ 56683-54-6
EC No (EINECS or ELINCS) ‡ 260-337-6
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H32O
Molecular mass ‡ 240.430 g/mol
Structural formula ‡ OH

EFSA Journal 2014;12(1):3524 461


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ >91% purity


(geometric isomers <6%)
Total blend with isomer: >97%
-0.2°C
Reference required
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ >91% purity
(geometric isomers <6%)
Total blend with isomer: >97%
151-156°C (266Pa)
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ >91% purity
(geometric isomers <6%)
Total blend with isomer: >97%
light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state >91% purity
purity) ‡ (geometric isomers <6%)
Total blend with isomer: >97%
2.63 x 10-2 Pa (25°C)
Open for applicability of data to all the SCLP‘s
3
Henry‘s law constant ‡ 0.100 - 0.0003 kPa m /mol
Range bridged from E,E-8,10-dodecadienol
(80-99% purity)
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ >91% purity
(state temperature, state purity) (geometric isomers <6%)
Total blend with isomer: >97%
soluble in n-hexane, heptane, xylene, toluene,
dichloromethane, acetone, methanol, ethanol, ethyl
acetate
Reference required
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s

EFSA Journal 2014;12(1):3524 462


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Partition co-efficient ‡ >91% purity


(state temperature, pH and purity) (geometric isomers <6%)
Total blend with isomer: >97%
>10000
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 463


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Lepidopteran Pheromones

Summary of representative uses evaluated ((Z)-11-Hexadecen-1-ol)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Corn AT Pheromone F Sesamia VP 1 10-12 Before begin 1 per n. a. n. a. n .a. 10-12 n.a.
ES dispenser / nonagrioides mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK
Vegetable Spain Konaga-con F Plutella VP 220mg 1000 Before begin 1 n. a. n. a. n. a. 1000dis. n. a.
Plus / xylostella /m dis./ha of 1.st x 220mg
Shin Etsu (1%a.i generation =
(CBC- . = moth flight of 220g/ha
Europe) 2.2mg 1.st species (1% a.i.
) occurs =
1000dis.
x 2.2mg
=
2.2g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

EFSA Journal 2014;12(1):3524 464


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definiotion is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 466


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-11-hexadecen-1-ol
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-11-hexadecen-1-ol
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Rat LC50 inhalation ‡ > 5 mg/L air/4 h whole body exposure
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin irritation ‡ Irritant R38
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Eye irritation ‡ Non-irritant
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol
Skin sensitisation ‡ Sensitiser (M&K Maximisation test) R43
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

EFSA Journal 2014;12(1):3524 467


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Genotoxicity ‡ (Annex IIA, point 5.4)

no genotoxic potential in vitro in gene


mutation assays in bacteria and
chromosome aberration test
based on bridging from other SCLP alcohol:
(E,E)-8,10-dodecadien-1-ol

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity
Reproduction target / critical effect ‡ No data provided
Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

EFSA Journal 2014;12(1):3524 468


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)


Operator Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
38
RMS/peer review proposal

38
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

EFSA Journal 2014;12(1):3524 469


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Substance classified: (Z)-11-hexadecen-1-ol Xi ―Irritant‖


R38 ―Irritating to skin‖
R43 ―May cause sensitisation by skin contact‖

EFSA Journal 2014;12(1):3524 470


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

EFSA Journal 2014;12(1):3524 471


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

EFSA Journal 2014;12(1):3524 472


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-11-hexadecen-1-ol

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

EFSA Journal 2014;12(1):3524 473


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2050 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)
Dietary toxicity to birds No data provided
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Alcohols)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Fish Based on lowest endpoint 96 hr
LC50 >0.685 mm
(Brachydanio rerio) of SCLP Alcohols (semi- static)
Aquatic invertebrates Based on lowest endpoint 48 hr
EC50 0.3 mm
(Daphnia magna) of SCLP Alcohols (static)
Algae Based on lowest endpoint 72 hr EbC50 0.074 mm
(Scenedesmus subspicatus) of SCLP Alcohols (static) ErC50 0.221 mm
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity LD50 > 85 µg a.s./bee (based on lowest endpoint of SCLPs
Alcohols)
Acute contact toxicity LD50 203.3 µg a.s./bee (based on lowest endpoint of SCLP
Alcohols)

EFSA Journal 2014;12(1):3524 474


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Species Stage Test substance Exposure Endpoint Effect Trigger
Laboratory tests

Based on 20 day No
inhalation Mortality and
Chrysoperla available data adverse
Adults behavioral 50%
carnea for SCLP 0.12 g / 3.17 effects
effects
alcohols ppm reported
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-11-hexadecen-1-ol
water (Z)-11-hexadecen-1-ol
sediment (Z)-11-hexadecen-1-ol
groundwater (Z)-11-hexadecen-1-ol

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

EFSA Journal 2014;12(1):3524 475


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Active substance R50/53

EFSA Journal 2014;12(1):3524 476


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

21 (Z)-7-Tetradecenal

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-7-tetradecenal


Chemical name (CA) ‡ Z-7-tetradecenal
CIPAC No ‡ 879
CAS No ‡ 65128-96-3
EC No (EINECS or ELINCS) ‡ 265-494-9
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡

Identity of relevant impurities (of toxicological, Open


ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C14H26O
Molecular mass ‡ 210.360 g/mol
Structural formula ‡ O

EFSA Journal 2014;12(1):3524 477


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Data required


Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ Purity not stated
308°C
Noted reference has not been submitted, is
required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ 95%
Colourless liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state The study for (Z)-9-Hexadecenal can be regarded as
purity) ‡ representative.
3.11 x 10-2 Pa (25°C)
Open for applicability of data to all the SCLP‟s
Henry‘s law constant ‡ Data required
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ 80-100% soluble
(state temperature, state purity) bridged from SCLP acetates summary
80-99%purity.
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ Data required
(state temperature, pH and purity) Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: 110°C, 95% purity
Reference required
Open for applicability of data to all the SCLP‘s

EFSA Journal 2014;12(1):3524 478


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 479


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Summary of representative uses evaluated ((Z)-7-Tetradecenal)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Lemon AT Pheromone F Prays citri VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
Orange ES dispenser / mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Olives AT Pheromone F Prays oleae VP 1 10-12 Before begin 1 per n .a. n. a. n. a. 10-12 n.a.
ES dispenser / mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
st
IT r) in Funnel 1 species 12
NL trap occurring mg/ha
UK

Lemon Portugal Isonet-P / F Prays oleae VP 135mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.
Shin Etsu Prays citri /dispe dispenser/ of 1.st dispense
(CBC- nser ha generation r x 135
Europe) (65% moth flight of mg =
a.i. = 1.st species 135 g/ha
87.8m occurs (65% a.i.
g) =
87.8g/ha
)

EFSA Journal 2014;12(1):3524 480


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

EFSA Journal 2014;12(1):3524 481


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 482


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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-7-tetradecenal
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-7-tetradecenal
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Rat LC50 inhalation ‡ 4.46 (females) mg/L air/4 h whole body R20
exposure
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Skin irritation ‡ Non-irritant
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Skin sensitisation ‡ Sensitiser (based on chemical structure) R43

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

EFSA Journal 2014;12(1):3524 483


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Lepidopteran Pheromones

Genotoxicity ‡ (Annex IIA, point 5.4)

Data gap: Genotoxicity tests with SCLP


aldehydes have to be provided

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

EFSA Journal 2014;12(1):3524 484


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Lepidopteran Pheromones

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
39
RMS/peer review proposal
Substance classified: (Z)-7-tetradecenal Xn ―Harmful‖
R20 ―Harmful by inhalation‖
R43 ―May cause sensitisation by skin contact‖

39
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

EFSA Journal 2014;12(1):3524 485


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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

EFSA Journal 2014;12(1):3524 486


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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

EFSA Journal 2014;12(1):3524 487


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Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-7-tetradecenal

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

EFSA Journal 2014;12(1):3524 488


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Aldehydes)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER
insectivorous bird) Trigger
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests

No data
Fish 96 hr LC50
(Z)-7-Tetradecenal provided

Aquatic invertebrates Based on lowest endpoint 48 hr


EC50 0.58 mm
(Daphnia magna) of SCLP Aldehydes (flow-through)
72 hr EbC50 No data
Algae (Z)-7-Tetradecenal
ErC50 provided
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data provided


Acute contact toxicity No data provided

EFSA Journal 2014;12(1):3524 489


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
No data provided.
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-7-tetradecenal
water (Z)-7-tetradecenal
sediment (Z)-7-tetradecenal
groundwater (Z)-7-tetradecenal

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

EFSA Journal 2014;12(1):3524 490


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

22 (Z)-9-Hexadecenal

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-9-hexadecenal


Chemical name (CA) ‡ (Z)-9-hexadecenal
CIPAC No ‡ 881
CAS No ‡ 56219-04-6
EC No (EINECS or ELINCS) ‡ 260-064-2
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H30O
Molecular mass ‡ 210.360 g/mol
Structural formula ‡ O

EFSA Journal 2014;12(1):3524 491


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ >90% purity


(geometric isomers <5.5%)
Total blend with isomer: >95.5%
-26.3°C
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ >90% purity
(geometric isomers <5.5%)
Total blend with isomer: >95.5%
138-142°C (40Pa)
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ >90% purity
(geometric isomers <5.5%)
Total blend with isomer: >95.5%
light yellow transparent liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state >90% purity
purity) ‡ (geometric isomers <5.5%)
Total blend with isomer: >95.5%
3.11 x 10-2 Pa (25°C)
Reference required
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ Data required
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state >90% purity
purity and pH) ‡ (geometric isomers <5.5%)
Total blend with isomer: >95.5%
0.106mg/l (20°C)
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ >90% purity
(state temperature, state purity) (geometric isomers <5.5%)
Total blend with isomer: >95.5%
soluble in n-hexane, heptane, xylene, toluene,
dichloromethane, acetone, methanol, ethanol, ethyl
acetate
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s

EFSA Journal 2014;12(1):3524 492


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Partition co-efficient ‡ >90% purity


(state temperature, pH and purity) (geometric isomers <5.5%)
Total blend with isomer: >95.5%
>10000
Reference required
Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: both 62°C and 155 °C stated
Clarification requested
Reference required
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 493


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Summary of representative uses evaluated ((Z)-9-Hexadecenal)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Corn AT Pheromone F Heliothis zea VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
ES dispenser / mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Vegetables Italy Konaga-con F Plutella VP 220mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


, Spain Plus / xylostella /dispe dispenser/ of 1.st dispense
Shin Etsu nser ha generation r x
(CBC- (1.5% moth flight of 220mg =
Europe) a.i. = 1.st species 220g/ha
3.3mg/ occurs (1.5%
dispen a.i. =
ser) 3.3g/ha)

Rice Italy Isomate- F Chilo VP 320mg 100 Before begin 1 n. a. n. a. n. a. 100 n. a.


Spain RSB / suppressalis /dispe dispenser/ of 1.st dispense
Shin Etsu nser ha generation r x
(CBC- (5% moth flight of 320mg =
Europe) a.i. = 1.st species 32g/ha
16mg/ occurs (5% a.i.
m) =
1.6g/ha)

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

EFSA Journal 2014;12(1):3524 494


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

EFSA Journal 2014;12(1):3524 495


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

EFSA Journal 2014;12(1):3524 496


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-9-hexadecenal
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-9-hexadecenal
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Rat LC50 inhalation ‡ 4.46 (females) mg/L air/4 h whole body R20
exposure
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Skin irritation ‡ Non-irritant
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Skin sensitisation ‡ Sensitiser (based on chemical structure) R43

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

EFSA Journal 2014;12(1):3524 497


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Genotoxicity ‡ (Annex IIA, point 5.4)

Data gap: Genotoxicity tests with SCLP


aldehydes have to be provided

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

EFSA Journal 2014;12(1):3524 498


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Lepidopteran Pheromones

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
40
RMS/peer review proposal
Substance classified: (Z)-9-hexadecenal Xn ―Harmful‖
R20 ―Harmful by inhalation‖
R43 ―May cause sensitisation by skin contact‖

40
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

EFSA Journal 2014;12(1):3524 500


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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open


Spray application: no risk assessment submitted

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

EFSA Journal 2014;12(1):3524 501


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-9-hexadecenal

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

EFSA Journal 2014;12(1):3524 502


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Aldehydes)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
96 hr No data
Fish Z)-9-Hexadecenal LC50
provided
Aquatic invertebrates Based on lowest endpoint 48 hr
EC50 0.58 mm
(Daphnia magna) of SCLP Aldehydes (flow-through)
Algae 72 hr EbC50 No data
(Z)-9-Hexadecenal
ErC50 provided
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data provided


Acute contact toxicity No data provided

EFSA Journal 2014;12(1):3524 503


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
No data provided.
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-9-hexadecenal
water (Z)-9-hexadecenal
sediment (Z)-9-hexadecenal
groundwater (Z)-9-hexadecenal

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

EFSA Journal 2014;12(1):3524 504


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

23 (Z)-11-Hexadecenal

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-11-hexadecenal


Chemical name (CA) ‡ (Z)-11-hexadecenal
CIPAC No ‡ 875
CAS No ‡ 53939-28-9
EC No (EINECS or ELINCS) ‡ 258-876-7
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡

Identity of relevant impurities (of toxicological, Open


ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C16H30O
Molecular mass ‡ 238.414 g/mol
Structural formula ‡ O

EFSA Journal 2014;12(1):3524 505


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ 90%


-4 to -2°C
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 90%
120-126°c 0.3mmHg
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ not stated, assume >90% purity
light yellow liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 90%
purity) ‡ 1.2 x 10-3 mmHg or 0.16Pa (20°C)
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ Data required
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ not stated assume >90% purity
(state temperature, state purity) readily soluble in common organic solvents
including n-heptane, xylene, acetone
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ Data required
(state temperature, pH and purity) Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s
Flammability ‡ (state purity) SCLP actives are not flammables (statement)
Flash point: both 61°C and 152°C have been stated
90% purity
Clarification requested
Reference required
Open for applicability of data to all the SCLP‘s

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Lepidopteran Pheromones

Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 507


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Lepidopteran Pheromones

Summary of representative uses evaluated ((Z)-11-Hexadecenal)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Vegetables Italy Konaga-con F Plutella VP 220mg 1000 Before begin 1 n. a. n. a. n. a. 1000 n. a.


, Spain Plus / xylostella /dispe dispenser/ of 1.st dispense
Shin Etsu nser ha generation r x
(CBC- (41.6 moth flight of 220mg =
Europe) % a.i. 1.st species 220g/ha
= occurs (41.6%
91.5m a.i. =
g/disp 91.5g/ha
enser) )
Rice Italy Isomate- F Chilo VP 320mg 100 Before begin 1 n. a. n. a. n. a. 100 n. a.
Spain RSB / suppressalis /dispe dispenser/ of 1.st dispense
Shin Etsu nser ha generation r x
(CBC- (58% moth flight of 320mg =
Europe) a.i. = 1.st species 32g/ha
107.6 occurs (58% a.i.
mg/m) =
10.8g/ha
)
Rice AT Pheromone F Chilo VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.
ES dispenser / suppressalis mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

EFSA Journal 2014;12(1):3524 508


Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Crop and/ Member Product F Pests or PHI Remarks:


or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
(j) s (min) min max min
(d-f) (i) (f-h) (k)
max

Vegetables AT Pheromone F Heliothis VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser 7 armigera mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
IT r) in Funnel 1st species 12
NL trap occurring mg/ha
UK

Banana AT Pheromone F Opogona VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / sacchari mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
st
IT r) in Funnel 1 species 12
NL trap occurring mg/ha
UK

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residuie definition set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)
Rate and extent of oral absorption ‡ No data provided
Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-11-hexadecenal
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-11-hexadecenal
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


Rat LD50 dermal ‡ > 2000 mg/kg bw
Rat LC50 inhalation ‡ 4.46 (females) mg/L air/4 h whole body R20
exposure
Skin irritation ‡ Non-irritant
Eye irritation ‡ Non-irritant
Skin sensitisation ‡ Sensitiser (based on chemical structure) R43

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

Genotoxicity ‡ (Annex IIA, point 5.4)

Data gap: Genotoxicity tests with SCLP


aldehydes have to be provided

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

EFSA Journal 2014;12(1):3524 511


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Lepidopteran Pheromones

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

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Lepidopteran Pheromones

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
41
RMS/peer review proposal
Substance classified: (Z)-11-hexadecenal Xn ―Harmful‖
R20 ―Harmful by inhalation‖
R43 ―May cause sensitisation by skin contact‖

41
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Lepidopteran Pheromones

Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

EFSA Journal 2014;12(1):3524 514


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Lepidopteran Pheromones

Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-11-hexadecenal

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Lepidopteran Pheromones

Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw


Dietary toxicity to birds LC50 > 5620 mg/kg feed
Acute toxicity to mammals LD50 > 5000 mg/kg bw

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER Trigger
insectivorous bird)
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
Fish 96 hr No data
Z-11-Hexadecenal LC50
provided
No reliable
Aquatic invertebrates 48 hr
Z-11-Hexadecenal EC50 data
(Daphnia magna) (flow-through)
provided
Algae 72 hr EbC50 No data
Z-11-Hexadecenal
ErC50 provided
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data provided


Acute contact toxicity No data provided

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]

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Lepidopteran Pheromones

Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
No data provided.
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-11-hexadecenal
water (Z)-11-hexadecenal
sediment (Z)-11-hexadecenal
groundwater (Z)-11-hexadecenal

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

24 (Z)-13-Octadecenal

Listing of end points


Identity, Physical and Chemical Properties, Details of Uses, Further Information

Active substance (ISO Common Name) ‡ no ISO common name


Function (e.g. fungicide) Insecticide

Rapporteur Member State Austria


Co-rapporteur Member State --

Identity (Annex IIA, point 1)

Chemical name (IUPAC) ‡ (Z)-13-octadecenal


Chemical name (CA) ‡ (Z)-13-octadecenal
CIPAC No ‡ 878
CAS No ‡ 58594-45-9
EC No (EINECS or ELINCS) ‡ 261-349-4
FAO Specification (including year of No specification exists at the time of evaluation
publication) ‡
Minimum purity of the active substance as Open
manufactured ‡
Identity of relevant impurities (of toxicological, Open
ecotoxicological and/or environmental
concern) in the active substance as
manufactured
Molecular formula ‡ C18H34O
Molecular mass ‡ 266.468 g/mol
Structural formula ‡ O

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Lepidopteran Pheromones

Physical and chemical properties (Annex IIA, point 2)

Melting point (state purity) ‡ Purity not stated


-12 to -8°C
Reference and purity required
Open for applicability of data to all the SCLP‘s
Boiling point (state purity) ‡ 90% purity
165 - 174°C 2.5mmHg
Reference required
Open for applicability of data to all the SCLP‘s
Temperature of decomposition (state purity) Not relevant
Appearance (state purity) ‡ Purity not stated, assume >90% purity
light yellow liquid
Open for applicability of data to all the SCLP‘s
Vapour pressure (state temperature, state 90%
purity) ‡ 2.0 – 6.0 x 10-4mmHg (20°C) or 0.03 – 0.0008Pa
Open for applicability of data to all the SCLP‘s
Henry‘s law constant ‡ Data required
Open for applicability of data to all the SCLP‘s
Solubility in water (state temperature, state 7.1 x 10-4 – 0.14 g/L
purity and pH) ‡ 80-99% purity
bridged from SCLP acetates summary
Open for applicability of data to all the SCLP‘s
Effect of pH is not required*
Solubility in organic solvents ‡ Purity not stated, assume >90% purity
(state temperature, state purity) readily soluble in common organic solvents
including n-heptane, xylene, acetone
Open for applicability of data to all the SCLP‘s
Surface tension ‡ 38 - 50 mN/m at 0.01% in pure water
(state concentration and temperature, state whole group of SCLP actives
purity)
80-99% purity
Open for applicability of data to all the SCLP‘s
Partition co-efficient ‡ Data required
(state temperature, pH and purity) Open for applicability of data to all the SCLP‘s
Dissociation constant (state purity) ‡ Rapid degradation, evaporation and volatilization
can be expected for all SCLP actives
Open for applicability of data to all the SCLP‘s
UV/VIS absorption (max.) incl. ‡ Not required as section fate and behaviour does not
(state purity, pH) indicate any concern for dispenser application*
Open for applicability of data to all the SCLP‘s

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Lepidopteran Pheromones

Flammability ‡ (state purity) SCLP actives are not flammables (statement)


Flash point: 61°C
Purity not stated, assume >90% purity
Reference required
Open for applicability of data to all the SCLP‘s
Explosive properties ‡ (state purity) SCLP actives are not explosive (statement)
Oxidising properties ‡ (state purity) SCLP actives are not strong oxidising agents
(statement)

* Reduced data requirement according to OECD document No 12 [Guidance for Registration


Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)] is considered.

EFSA Journal 2014;12(1):3524 521


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Lepidopteran Pheromones

Summary of representative uses evaluated ((Z)-13-Octadecenal)


Crop and/ Member Product F Pests or PHI Remarks:
or situation State or name / G Group of Formulation Application Application rate per treatment (days)
Country Company or pests
I controlled
(a) (b) (l) (m)
(c)
Type Conc. method growth number interval kg water L/ha**) kg
of as kind stage & min max between as/hL**) as/ha**)
season application min max
s (min)
(d-f) (i) (f-h) (j) (k) min max min
max

Rice Spain Isomate- F Chilo VP 320mg 100 Before begin 1 n. a. n. a. n. a. 100 n. a.


RSB / suppressalis /dispe dispenser of 1.st dispense
Shin Etsu nser s/ha generation r x 320
(CBC- (11% moth flight of mg = 32
Europe) a.i. = 1.st species g/ha
35.2m occurs (11% a.i.
g) =
3.5g/ha)

Rice AT Pheromone F Chilo VP 1 10-12 Before begin 1 per n. a. n. a. n. a. 10-12 n.a.


ES dispenser / suppressalis mg/dis dispenser/ of 1st generatio dispense
FR DKSH penser ha, generation n r/ha x 1
GE (SiberHegne dispenser moth flight of mg = 10-
st
IT r) in Funnel 1 species 12
NL trap occurring mg/ha
UK

VP vapour releasing product in closed dispenser


n.a. not applicable
* filling amounts of ampoules

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the (i) g/kg or g/l
use situation should be described (eg. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at
(c) eg. biting and suckling insects, soil born insects, foliar fungi, weeds time of application
(d) eg. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical conditions
(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 of use must be provided
(f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval
(g) Method, eg. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions
(h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants -
type of equipment used must be indicated

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Lepidopteran Pheromones

Methods of Analysis
Analytical methods for the active substance (Annex IIA, point 4.1)

Technical as (analytical technique) Open


Impurities in technical as (analytical technique) Open
Plant protection product (analytical technique) Open

Analytical methods for residues (Annex IIA, point 4.2)


Residue definitions for monitoring purposes

Food of plant origin Open


Food of animal origin No residue definition is set
Soil Open
Water surface Open
drinking/ground Open
Air Open

Monitoring/Enforcement methods

Food/feed of plant origin (analytical technique Open


and LOQ for methods for monitoring purposes)
Food/feed of animal origin (analytical No residue definition is set
technique and LOQ for methods for monitoring
purposes)
Soil (analytical technique and LOQ) Open

Water (analytical technique and LOQ) Open

Air (analytical technique and LOQ) Open

Body fluids and tissues (analytical technique Not relevant, active substance is not classified toxic
and LOQ) or highly toxic.

Classification and proposed labelling with regard to physical and chemical data
(Annex IIA, point 10)

RMS/peer review proposal


Active substance None

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Lepidopteran Pheromones

Impact on Human and Animal Health


Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point
5.1)

Rate and extent of oral absorption ‡ No data provided


Distribution ‡ No data provided
Potential for accumulation ‡ No data provided
Rate and extent of excretion ‡ No data provided
Metabolism in animals ‡ No data provided
Toxicologically relevant compounds ‡ (Z)-13-octadecenal
(animals and plants)
Toxicologically relevant compounds ‡ (Z)-13-octadecenal
(environment)

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral ‡ > 5000 mg/kg bw


based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Rat LD50 dermal ‡ > 2000 mg/kg bw
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Rat LC50 inhalation ‡ 4.46 (females) mg/L air/4 h whole body R20
exposure
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Skin irritation ‡ Non-irritant
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Eye irritation ‡ Non-irritant
based on bridging from other SCLP
aldehyde: (Z)-11-hexadecenal
Skin sensitisation ‡ Sensitiser (based on chemical structure) R43

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect ‡ No data provided


Relevant oral NOAEL ‡ No data provided
Relevant dermal NOAEL ‡ No data provided
Relevant inhalation NOAEL ‡ No data provided

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Genotoxicity ‡ (Annex IIA, point 5.4)

Data gap: Genotoxicity tests with SCLP


aldehydes have to be provided

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect ‡ No data provided


Relevant NOAEL ‡ No data provided
Carcinogenicity ‡ No data provided

Reproductive toxicity (Annex IIA, point 5.6)


Reproduction toxicity

Reproduction target / critical effect ‡ No data provided


Relevant parental NOAEL ‡ No data provided
Relevant reproductive NOAEL ‡ No data provided
Relevant offspring NOAEL ‡ No data provided

Developmental toxicity

Developmental target / critical effect ‡ No data provided


Relevant maternal NOAEL ‡ No data provided
Relevant developmental NOAEL ‡ No data provided

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity ‡ No data provided


Repeated neurotoxicity ‡ No data provided
Delayed neurotoxicity ‡ No data provided

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies ‡ No data provided


Studies performed on metabolites or impurities No data provided

Medical data ‡ (Annex IIA, point 5.9)

Regular medical checks of manufacturing plant


personnel did not report any incidents of poisoning
or adverse effects.

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Lepidopteran Pheromones

Summary (Annex IIA, point 5.10) Value Study Safety


factor
ADI ‡ Not allocated No adequate
study available
AOEL ‡ Not allocated
for derivation of
ARfD ‡ Not allocated reference values

Dermal absorption ‡ (Annex IIIA, point 7.3)

Vapour releasing product in closed dispenser No data available

Exposure scenarios (Annex IIIA, point 7.2)

Operator Vapour releasing product in closed dispenser (VP):


No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with operator exposure
levels.
Workers Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with worker exposure
levels.
Bystanders Vapour releasing product in closed dispenser (VP):
No reliable range of naturally occuring backgound
levels could be retrieved, a data gap has been
identified to provide naturally occuring background
level to allow a comparison with bystander
exposure levels.

Classification and proposed labelling with regard to toxicological data (Annex IIA,
point 10)
42
RMS/peer review proposal
Substance classified: (Z)-13-octadecenal Xn ―Harmful‖
R20 ―Harmful by inhalation‖
R43 ―May cause sensitisation by skin contact‖

42
It should be noted that proposals for classification made in the context of the evaluation procedure under Regulation (EC)
No 1107/2009 are not formal proposals. Classification is formally proposed and decided in accordance with Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, 1-1355.

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Residues
Summary of residues data according to the representative uses on raw agricultural
commodities and feedingstuffs (Annex IIA, point 6.3, Annex IIIA, point 8.2)
Data gap is set to address the natural background levels of SCLPs based on field measurements and to
demonstrate that the use of SCLPs as a plant protection product according to the use pattern will result
in concentrations not exceeding the naturally occurring SCLPs levels in the environment.

Proposed MRLs (Annex IIA, point 6.7, Annex IIIA, point 8.6)
Open.

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Fate and Behaviour in the Environment


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Dispenser application: open

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Dispenser application: open

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Dispenser application: open

Soil adsorption/desorption (Annex IIA, point 7.1.2.)

Kf/Koc Dispenser application: open

Kd

pH dependence (yes/no) (if yes type of


dependence)

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching Dispenser application: open

PEC (soil) (Annex IIIA, point 9.1.3)

Dispenser application: open

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Photolytic degradation of active substance and Dispenser application: open


relevant metabolites

PEC (surface water) (Annex IIIA, point 9.2.3)

Dispenser application: open

PEC (sediment) (Annex IIIA, point 9.2.3)

Dispenser application: open

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PEC (groundwater) (Annex IIIA, point 9.2.1)

Dispenser application: not required

Fate and behaviour in air (Annex IIA point 7.2.2, Annex IIIA, point 9.3)

Laboratory study Dispenser application: open

Photochemical oxidative degradation in air Data gap

PEC (air) (Annex IIIA, point 9.3)

Dispenser application: open

Definition of the residue (Annex IIA, point 7.3)

Relevant to the environment (Z)-13-octadecenal

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study) Not required, not available

Surface water (indicate location and type of study) Not required, not available

Ground water (indicate location and type of study) Not required, not available

Air (indicate location and type of study) Not required, not available

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data Dispenser application: open

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Peer review of the pesticide risk assessment of the active substance Straight Chain
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Ecotoxicology
General remark: As studies were not available for each substance for all groups of organisms it was
considered appropriate to regard the lowest endpoint from substances of a class (aldehyde
pheromones, acetate pheromones etc.) of pheromones as representative for this whole class of
pheromones (based on the principles of ―bridging‖ thoughout the whole group of SCLPs).

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Acute toxicity to birds LD50 > 2250 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)
Dietary toxicity to birds LC50 > 5620 mg/kg feed (based on lowest endpoint of
SCLP Aldehydes)
Acute toxicity to mammals LD50 > 5000 mg/kg bw (based on lowest endpoint of
SCLP Aldehydes)

Toxicity/exposure ratios for terrestrial vertebrates (Annex IIIA, points 10.1 and 10.3)
Application
Category (e.g.
rate [kg Crop Time-scale TER
insectivorous bird) Trigger
as/ha]
Risk assessment open

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2,
Annex IIIA, point 10.2)
Time-scale Toxicity
Group Test substance Endpoint
(Test type) [mg/L]
Laboratory tests
No data
Fish (Z)-13-Octadecenal 96 hr LC50
provided
Aquatic invertebrates Based on lowest endpoint 48 hr
EC50 0.58 mm
(Daphnia magna) of SCLP Aldehydes (flow-through)
EbC50 No data
Algae Z)-13-Octadecenal 72 hr
ErC50 provided
n…nominal, im…initial measured, mm…mean measured

Toxicity/exposure ratios for the most sensitive aquatic organisms (Annex IIIA, point 10.2)
Application rate Time Distance
Crop Organism TER Trigger
[kg as/ha] scale (m)
Risk assessment open

Effects on honeybees (Annex IIA, point 8.7, Annex IIIA, point 10.4)

Acute oral toxicity No data provided


Acute contact toxicity No data provided

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Peer review of the pesticide risk assessment of the active substance Straight Chain
Lepidopteran Pheromones

Hazard quotients for honey bees (Annex IIIA, point 10.4)


Application rate
Crop Route Hazard quotient Trigger
[kg as/ha]
Risk assessment open

Effects on other arthropod species (Annex IIA, point 8.8, Annex IIIA, point 10.5)
Dose [g a.s./
Species Stage Test substance Endpoint Effect Trigger
dispenser]
Laboratory tests
No data provided.
‗-‗ figure indicates a positive effect

Effects on earthworms (Annex IIA point 8.9, Annex IIIA, point 10.6)
Acute toxicity No data provided
Reproductive toxicity No data provided

Toxicity/exposure ratios for earthworms (Annex IIIA, point 10.6)


Application rate
Crop Time-scale TER Trigger
[kg as/ha]
Risk assessment open

Effects on soil micro-organisms (Annex IIA point 8.10, Annex IIIA, point 10.6)
Nitrogen mineralization No data provided
Carbon mineralization No data provided

Effects on terrestrial vascular plants (Annex IIA, point 8.12, Annex IIIA, point 10.8)
No data provided

Residues definition (consider all relevant metabolites requiring further assessment from the fate
section)
Compartment Ecotoxicologically relevant residue
soil (Z)-13-octadecenal
water (Z)-13-octadecenal
sediment (Z)-13-octadecenal
groundwater (Z)-13-octadecenal

Classification and proposed labeling with regard to ecotoxicological data (Annex IIA, point 10
and Annex IIIA, point 12.3)
RMS/EPCO proposal

Active substance R50/53

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Lepidopteran Pheromones

APPENDIX B – USED COMPOUND CODE(S)

Code/Trivial name* Chemical name Structural formula

--- --- ---

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ABBREVIATIONS
1/n slope of Freundlich isotherm
λ wavelength
decadic molar extinction coefficient
°C degree Celsius (centigrade)
µg microgram
µm micrometer (micron)
a.s. active substance
AChE acetylcholinesterase
ADE actual dermal exposure
ADI acceptable daily intake
AF assessment factor
AOEL acceptable operator exposure level
AP alkaline phosphatase
AR applied radioactivity
ARfD acute reference dose
AST aspartate aminotransferase (SGOT)
AV avoidance factor
BCF bioconcentration factor
BUN blood urea nitrogen
bw body weight
CAS Chemical Abstracts Service
CFU colony forming units
ChE cholinesterase
CI confidence interval
CIPAC Collaborative International Pesticides Analytical Council Limited
CL confidence limits
cm centimetre
d day
DAA days after application
DAR draft assessment report
DAT days after treatment
DM dry matter
DT50 period required for 50 percent disappearance (define method of estimation)
DT90 period required for 90 percent disappearance (define method of estimation)
dw dry weight
EbC50 effective concentration (biomass)
EC50 effective concentration
ECHA European Chemical Agency
EEC European Economic Community
EFSA European Food Safety Authority
EINECS European Inventory of Existing Commercial Chemical Substances
ELINCS European List of New Chemical Substances
EMDI estimated maximum daily intake
ER50 emergence rate/effective rate, median
ErC50 effective concentration (growth rate)
EU European Union
EUROPOEM European Predictive Operator Exposure Model
f(twa) time weighted average factor
FAO Food and Agriculture Organisation of the United Nations
FIR Food intake rate
FOB functional observation battery
FOCUS Forum for the Co-ordination of Pesticide Fate Models and their Use
g gram

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GAP good agricultural practice


GC gas chromatography
GCPF Global Crop Protection Federation (formerly known as GIFAP)
GGT gamma glutamyl transferase
GM geometric mean
GS growth stage
GSH glutathion
h hour(s)
ha hectare
Hb haemoglobin
Hct haematocrit
hL hectolitre
HPLC high pressure liquid chromatography
or high performance liquid chromatography
HPLC-MS high pressure liquid chromatography – mass spectrometry
HQ hazard quotient
IEDI international estimated daily intake
IESTI international estimated short-term intake
ISO International Organisation for Standardisation
IUPAC International Union of Pure and Applied Chemistry
JMPR Joint Meeting on the FAO Panel of Experts on Pesticide Residues in Food and
the Environment and the WHO Expert Group on Pesticide Residues (Joint
Meeting on Pesticide Residues)
Kdoc organic carbon linear adsorption coefficient
kg kilogram
KFoc Freundlich organic carbon adsorption coefficient
L litre
LC liquid chromatography
LC50 lethal concentration, median
LC-MS liquid chromatography-mass spectrometry
LC-MS-MS liquid chromatography with tandem mass spectrometry
LD50 lethal dose, median; dosis letalis media
LDH lactate dehydrogenase
LOAEL lowest observable adverse effect level
LOD limit of detection
LOQ limit of quantification (determination)
m metre
M/L mixing and loading
MAF multiple application factor
MCH mean corpuscular haemoglobin
MCHC mean corpuscular haemoglobin concentration
MCV mean corpuscular volume
mg milligram
M&K Magnusson & Kligman
mL millilitre
mm millimetre
mN milli-newton
MRL maximum residue limit or level
MS mass spectrometry
MSDS material safety data sheet
MTD maximum tolerated dose
MWHC maximum water holding capacity
NESTI national estimated short-term intake
ng nanogram
NOAEC no observed adverse effect concentration

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Lepidopteran Pheromones

NOAEL no observed adverse effect level


NOEC no observed effect concentration
NOEL no observed effect level
OECD Organisation for Economic Co-operation and Development
OM organic matter content
Pa pascal
PD proportion of different food types
PEC predicted environmental concentration
PECair predicted environmental concentration in air
PECgw predicted environmental concentration in ground water
PECsed predicted environmental concentration in sediment
PECsoil predicted environmental concentration in soil
PECsw predicted environmental concentration in surface water
pH pH-value
PHED pesticide handler's exposure data
PHI pre-harvest interval
PIE potential inhalation exposure
pKa negative logarithm (to the base 10) of the dissociation constant
Pow partition coefficient between n-octanol and water
PPE personal protective equipment
ppm parts per million (10-6)
ppp plant protection product
PT proportion of diet obtained in the treated area
PTT partial thromboplastin time
QSAR quantitative structure-activity relationship
r2 coefficient of determination
REACH Registration, Evaluation, Authorisation of CHemicals
RMS rapporteur Member State
RPE respiratory protective equipment
RUD residue per unit dose
SANCO Directorate-General for Health and Consumers
SC suspension concentrate
SCLP straight chain Lepidopteran pheromones
SD standard deviation
SFO single first-order
SSD species sensitivity distribution
STMR supervised trials median residue
t1/2 half-life (define method of estimation)
TER toxicity exposure ratio
TERA toxicity exposure ratio for acute exposure
TERLT toxicity exposure ratio following chronic exposure
TERST toxicity exposure ratio following repeated exposure
TK technical concentrate
TLV threshold limit value
TMDI theoretical maximum daily intake
TRR total radioactive residue
TSH thyroid stimulating hormone (thyrotropin)
TWA time weighted average
UDS unscheduled DNA synthesis
UV ultraviolet
W/S water/sediment
w/v weight per volume
w/w weight per weight
WBC white blood cell
WG water dispersible granule

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WHO World Health Organization


wk week
yr year

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