RAW MATERIAL DOCUMENTATION

FOR.05.06 rev.2

4085100G XERADIN
Version: 20 - 21/09/2009

Exclusive N.A. Distributor

CENTERCHEM, INC. NORWALK, CT
Ph: 203-822-9800 Fax: 203-822-9820
www.centerchem.com
1. PRODUCT IDENTIFICATION
Trade Name: XERADIN
Manufacturer: PROVITAL,S.A.
Responsible for the Safety Assessment: Lourdes Mayordomo
Tf./Fax: 3493-7192350/7190294
e-mail: l.mayordomo@provitalgroup.com
Kind of Raw Material: Active Ingredient
Function of the Ingredient (CTFA Handbook): Not reported
Function of the Ingredient (UE Inventory): Astringent, Anti-seborrhoea, Skin Conditioning,
Soothing
Maximum Suggested Concentration: 20%
INCI approved in: Registered in EU, USA
Japanese Name: ---

2. PRODUCT COMPOSITION
Components Breakdown (INCI). Including actives, solvents,
solvents, preservatives, antioxidants
antioxidants and other
additives:
dditives:

[EU] CAS EINECS

Propanediol 60 - 80 % 50463-2 207-997-3
26264-14-2
Aqua 15 - 31 % 7732-18-5 231-791-2
Glycerin 2-5% 56-81-5 200-289-5
Salvia Sclarea Extract 1 - 2,5 % 84775-83-7 283-911-8
Preservatives
Sodium Benzoate 0,15 - 0,25 % 532-32-1 208-534-8
Potassium Sorbate 0,15 - 0,25 % 24634-61-5 246-376-1
-------------------------------------------------------------------------------------------------------------
PCPC [CTFA] CAS EINECS
Propanediol 60 - 80 % 504-63-2 207-997-3
Water 15 - 31 % 7732-18-5 231-791-2
Glycerin 2-5% 56-81-5 200-289-5
Salvia Sclarea (Clary) Extract 1 - 2,5 % --- ---
Preservatives
Sodium Benzoate 0,15 - 0,25 % 532-32-1 208-534-8
Potassium Sorbate 0,15 - 0,25 % 24634-61-5 246-376-1

Impurities:

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
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 RAW MATERIAL DOCUMENTATION

FOR.05.06 rev.2

4085100G XERADIN
Version: 20 - 21/09/2009

Heavy Metals (as Pb) Less than 20 ppm.

Pesticides Non applicable.

3. TOXICOLOGICAL INFORMATION
Data obtained in our own toxicological tests and/or bibliographical research
Animal testing:
This product has not been the subject of animal testing or retesting for cosmetic purposes by or on
behalf of this company.
General information:
American Herbal Products Association: Salvia sclarea herb - Herbs that can be safely consumed when
used appropriately (Class 1)
The following substances have the GRAS status("Generally Recognized As Safe"): Glycerin
(21CFR182.1320)
Classification according to Council of Europe (*):
Not classified
*(1)- Non-recommended ingredients (2)-Ingredients which could not be assessed (3) Recommended
ingredients
Cytotoxicity:
XERADIN (Cod. 48051): Neutral Red Releasing Method on SIRC cell line. The product shows
unimportant cytotoxicity.
Skin Irritation:
XERADIN (Cod. 40851) at 20%: Patch Teston 10 volunteers, Results: Very good cutaneous
compatibility.
Glycerin (RTECS nMA8050000): Draize Test in the skin of rabbit , 500 mg, 24 h, Mild
Skin Sensitization:
XERADIN (Cod. 40851). Marzulli and Maibach's Method: Human Repeated Insult Patch Test. Study on
52 volunteers, product tested at 20%. No pathological irritation, nor sensitisation reaction was
registered. Xeradin is classified as a No-Sensitizant product.
Undiluted Clary sage oil or at 8% in petrolatum caused no sensitisation effects. A maximisation test
failed to sensitize any of 25 volunteers ( BoDD- Botanical Dermatology Database)
Eye Irritation:
XERADIN (Cod. 40851): The Hen's Eggs Test on the Chorioallantoic Membrane (HET-CAM), product
tested at 20%, Mean Irritation Index = 1.0. The trial product can be considered as WELL TOLERATED
at the ocular level.
Glycerin (RTECS nMA8050000): Draize Test in the eye of rabbit ,126 and 500 mg, 24 h, Mild
Mutagenicity:
XERADIN (Cod. 40851): Genic Mutation Bacteria In Vitro Test (Ames Test), using 5 strains of
Salmonella thyphimurium (TA1535, TA1537, TA98, TA100 and TA102), both in the presence and
absence of metabolic activation system (S-9). The product was tested at five dose levels betweeen3.56
and 57 mg/plate. No significant increase in the number of revertants was noted in any of the strains.
The trial product can be considered as: No mutagenic.
Glycerin: DNA inhibition in human lymphocyte, 200 mmol/l (PNASA 6 79, 1171, 1982) Cytogenic
Analysis rat p.o., 1 g/Kg (TGANAK 19, 436, 1985)
Acute toxicity:
Clary sage oil (RTECS nGF1170000): LD50 p.o. rat = 5600 mg/kg
Glycerin (RTECS n MA8050000):LD50 in mouse:p.o.=4090 mg/kg, i.p.=8700 mg/kg, s.c.=91 mg/kg,
i.v.= 4250mg/kg. LD50 in rabbit: p.o.=27 g/kg, skin>10g/kg, i.v.=53 g/kg
Glycerin (RTECS n MA8050000): LD50 in rat : p.o.=12600 mg/kg, i.p.=4420 mg/kg, s.c.=100 mg/kg,
i.v.=5566 mg/kg. LDLo in rat i.m. =10 mg/kg, TDLo in rat i.m.=5 g/kg
Subchronic and chronic toxicity:

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
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 RAW MATERIAL DOCUMENTATION

FOR.05.06 rev.2

4085100G XERADIN
Version: 20 - 21/09/2009

Glycerin (RTECS n MA8050000): TDLo p.o.= rat 16800mg /Kg/28D-C; rat 96 g/Kg/90D-I; mouse
560 g/Kg/8W-C; mouse 2800 mg/Kg/25W-C
Reproductive effects:
Glycerin:(RTECS n MA8050000) rat, i.t. TDL0 = 280 mg/Kg, 2 Days, male ; rat o. TDL0=100 mg/Kg, 1
Day, male ;rat, i.t., TDL0=862 mg/Kg, 1 Day, male
Other data:
Glycerin (RTECS n MA8050000): LC50 rat inhalation > 570/mg/m3/1H
Glycerin (RTECS nMA8050000): TDLo oral in human = 1428 mg/kg

4. ECOLOGICAL DATA
Biodegradability:
Biodegradability:
Glycerin (HSDB n492,Revisin:20050624).Activated sludge test:220 mg/l resulted in a COD of
97%;Test in a 5 days:BOD= 82%. Glycerin is considered a substance easily degraded
Aquatic Toxicity:
Toxicity:
Glycerin:Inhibition multiplication test in algae (Microcystis aeruginosa) and protozoa (Entosiphon
sulcatum) Toxicity threshold=2900 mg/l and 3200 mg/l (HSDB n492,Revision:20050624)
Glycerin (HSDB n492,Revision:20050624):LC50 goldfish > 5000 mg/l/24 h
Other data:
data:
No data available.

5. CONCLUSION
The components of this product have registered adverse effects neither in its traditional uses nor in the
historical marketing of this company. These data and the available toxicological information lead to the
conclusion that the use of this product, under the normal conditions of cosmetic use and at the
maximum recommended concentration, involves no risk for consumers.

This information agrees with the current state of our knowledge and is based on our experience and in sources that we believe to be creditable. It
does not imply any responsibility for damages, losses or expenses derived from the handling, storage, use or elimination of the product. It does not
exempt of the obligation of the client to guarantee the safety of its product.
3