1 - 28 Days

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BIOEQUIVALENCE STUDY CENTRE
, Department of Pharmaceutical Technology, Jadavpur University, Kolkata . 700 032
Tel: (033) 24146967 Fax: (033) 2414618616266, Email: tkpaL12@yahoo.com, Website: www.biostudy.in ,
TITLE: S
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SPONSOR:
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'L-H..1l.LJ!' INVESTIGATOR:
CLINI CAL PHAILl\'IACOLOG1ST:
, ~ \ ARTICLE: 100mg.
In Collaboration with TAAB BIOSTIJDY SERVICES, No_67/lB, Ibrahimpur Road, Floor, Flat No_6,
Kolkata - 700032_ '
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Approved by DCGI vide Letter No. 4-14/97-DC pt (I) dt. 21'( OCT 2002
ISO 9001:2000 Certified
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" BIOEQUIVALENCE STUDY CENTRE
Department 0/Pharmaceutical Technology.
Jadavpur University. Kolkata - 700 032 .
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Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000 Certified
CONTENTS
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4 STATEMENT OF COMPLIANCE
-1--
PERSONNEL INVOLVED 1N TIlE STUDY .5_
6
PPEFACE
SUMMARY AND CONCLUSION
7
General 7
7
-
Schedule
MATERIALS ANDMEIHODS . 8
Test System 8
METHODS 9
-
9 Randomization, Numbering & Grouping ofAnimals
9
-
Route of Administration
f------
JustifIcation for Selection ofWister Strain Rats for the Study 9
Route of Administration and Reason for Choice 9
Dose P!f'Paration 9
OBSERVATIONS 10
10
--
Symptoms
Mortality 10
Body Weight 10 .
Food Consumption 10
TERM1NAL STUDIES 10,
RESULTS 12
I
Clinical Signs Mortality Body Weight 121
Food Consumption 13
Haematologicai Investigations 13
Biochemical Investigations 13
13
--
Organ Weight
Necropsy 14
Histopathology 14
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ACECLOFENAC TABLETS lOOmg._KUSUM
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BIOEQUIVALENCE STUDY CENTRE .
Department ofPharmaceutical Technology,
Jadavpur University, Kolkata - 700 032 .
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CONTENTS OF FIGURES, TABLES AND APPENDICES
/""'"'!
/, IFIGURES
I
Figures Page No
. Group Mean Body Weight I, II IS; 16
Group Mean Food Consumption 17,18 Ill, Iv
. ,
TABLES' Page No
Allocation Of Animals To VariouS Groups
Tables
A 19
Summary Of Clinical Signs OfIntoxication 20 B
21
---
Mortality C
Group Mean Body Weight D 22
Group Mean Food Consumption 23
Group Mean Haematology
E
24-25
Group Mean Blood Chemistry
F
26
Group Mean Organ Weight
I Absolute Values (g)
G
H 27
I Relative Values _(%) I 28
Summary Of Gross Pathology Findings 29
Summary Of Histopailiology Findings
J
K 30-31
!
APPENDICES (INDIVIDUAL ANIMAL, DATA) Appendix Page No
r,
Body Weight
---
32 -35
Haematology
II-Is
36-43
Blood Chemistry
fil-fig
44-47
Organ Weights
I Absolute Values (g)
illI-IIIs
48-- 51
I Relative Values (%)
IVI IVs
52 - 55
Gross And Histopathology Findings
Vl- Vs
VlI-Vh 56 - 57
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ACECLOFENAC TABLETS
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... Department of Pharmaceutical Technology, Jadavpur University, Kolkata . 700 032

Tel: (033)24146967 Fax: (033) 24146186 J6266, E-mail tkpal 12@yahoo.com, Website: www.biostudy.in,
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INSTITUTIONAL ANIMALETHlqSCQMMlllEE
TaabBiostudy -Services
i
No.67J1B. ibrahlmpur Road
f
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Flat No. 6,
BioequivatenceSludyCentret,.Oepartmeo\ofPharmaceuticaITeehriotogy,
.' Jadavpur University, .Kolkata ... 700.,032
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The members of the Institutional Animal Ethics Committee. (lAEC) navesautiniZed

. various aspects QftheprotOcols tor carrying out tt>xicitystudy
ofthe following drug on rats andmiee andJlave apptqved- to be pedc;mned
.
at the TaahBiostudy Services$ No. 3
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FlOOr, Flat No:; .6,
DePartment of PharmaceuucalTechnology, JaMVpur
Koikata .... 700032, West BengaL
Narneofthe drug: IACECLOFENAC TABLETS loom--;]
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Approved by DCGI vide Letter No. 4-14/97-DC Pt (I) dt. 21st' OCT 2002

ISO 9001:2000Celtlfled
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Jadavpur University, Kolmta - 700032 1 1 I i V ~
Tel: (033) 24146967 Fax: (033) 2414618616266 1S09001:2CDIJ Certified
STATEMENT OF COMPLIANCE
Project No. TOXSC (r) ACFT 0610
Test Artic::1e ACECLOFENAC TABLETS 10Omg.
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Project Title : Subchl'Onic Oral Toxicity Study (28 days)
Bach no. : KOO4fTI013
We hereby attest to the authenticity ofthe study and guarantee that the data is correct and
accurate to the best ofour knowledge and that the study was performed in accordance with
the procedUre and the principles ofGood Laboratory Practice for the 1esting of chemicals.
;--.....\ We hereby attest that this study was conducted in compliance with Protocol submitted to and
approved by the sponsor.
The study also complies with the schedule Y of Drugs and Cosmetic Act (I940} and
regulations of the Committee for the Purpose of Control and Supervision of Experiments on
Animals.
Prof (Dr.) T. K Pal
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Chief Investigator Signature Date
Dr. S. Agarwal
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Quality Assurance Unit Signature Date
Dr. T. K Chattaraj, M.D.
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Clinical Pharmacologist Signature Date
ACECLOFENAC TABLETS 100mg._KUSUll
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Jadavpur University, Kolkata - 700 032 IruvS
Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9001:2000 Certified
PERSONNEL 1 i ~ V O L VED IN mE STUDY
Cbief Investigator Prof (Dr.) T. K Pal
Clinical Pbarmacologist Dr. T. K Chanaraj, M.D.
Quality Assurance Unit
Prof (Dr.) S. G. Dastidar
Dr. S. Agarwal
Dr. Anjan Das, M. D.
Investigating Team
Mr. Anirbandeep Bose
Mr. Soumendra Damar
Mr. Nilendra Chatterjee
Mr. Bikash Roy
Mr. Subhro Dutta
Mr. Arun Ghorai
Mr. Sanjay Ghorai
Mr. Ratan Gupta
ACECLOFENAC TABLETS lOOmg,:-KUSUM
5
Jadavpur University, Kolkata - 700 032 " .-

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SUMMARY AND CONCLUSION
The present investigation deals with Sub-chronic Toxicity Test (28 days) of
"CF"Ln]fENAC 'T'.tDT Frn;;:: 1nRMC on'XT;rlar
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5 mgIKg and 10 mg/kg body weight in accordance with the schedule Y of drugs and
Cosmetic Act (1940). The animals of both sex from control and different dose groups
exhibited normal body weight gain 1:luoughout the dosing period of 28 days.
The quantity of food consumption by the animals was f01.md to be comparable with that of
the control animal group.
"There was no abnormality and lesion found from Histopathological Exarn:ination of the
organs viz. Adrenals, Heart, Kidneys, Liver, Lungs, Stomach. "
The supplied drug ACECLOFENAC TABLETS lOOMG. did not show any significant
feature ofhaematological toxicity, behavioral toxicity, hepatotoxicity and nepherotoxicity in
any of the specimen.
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Chief Investigator : Prof (Dr.) T. K Pal
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Clinical Phannacologist : Dr. T. K Chattaraj, M.D.
1
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In Charge of. Quality Assurance Unit : Dr. S. Agarwal
ACECLOFENAC TABLETS lOOmgo_KUSUM
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Jadavpur University, Kolkata - 700 032 ' ;-:::
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Tel.- (033) 24146967 Fax: (033) 24146186/6266 ISO 9001 :2JDD Certified
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PREFACE
General
Title
Sponsor
Chief Investigator ..
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Testing Facility
Project No.
Test Article
/
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Schedule
Date oftreatment (Day 1)
Date of termination (Day 29)
Date of reporting
Sub chronic Oral Toxicity Study (28 day)
KUSUM HEALTHCARE PVT. LTD.
2114, BHAGAT SINGH MARG, NEW DEUD:..- 110
001 (INDIA).
. PROF. (DR)T.K PAL
BIOEQUIVALENCE STUDY CENTER
DEPARTMENT OF PHARMACEUTICAL
TECHNOLOGY, lADAVPUR UNIVERSTIY,
KOLKATA 700032.
In Col1aboration with
TAAB BIOSTUDY SERVICES, No.67I1B, lbrahimpur
Road, 3
m
Floor, Flat No.6, Kolkata 700032.
TOXSC (r) ACFT 0610
ACECLOFENAC TABLETS l00mg.
. 24.02.2010
24.03.2010
01.06.2010
ACECLOFENAC TABLETS l00mgo_KUSlll\l
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BIOEQUIVALENCE STuDy CENTRE
Jadavpur University, Kolkala - 700031 .
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MATERIALS AND METHOD
TEST SYSTEM
Species Rat
Strain Wister Strain Rats
Source Animal house, IleB, Kolkata
Sex Male and female
Age 6to8weeks
No. Ofanimals per dose level 6 per sex per dose
Acclimation Seven days prior to dosing
Identification ofanimals By cage number and individual marking on
fur
Diet PelIeted feed supplied by
Mis Ghosh Enterprise, Kolkata
Water
Aquaguard pure water in glass bottles
adlibitum
Housing
The rats were housed 6 each; ofthe same sex
in polycarbonate cages provided with
bedding of husk The temperature was
maintained in between 20 to 24C and
relative humidity between 30 to 70%; 12
hours each of dark and light cycle was
".
maintained.
/ ~ '
Dose
Male: 0 mgIKg , 2 mgIKg, 5 mgIKg and
10 mglkg body weight
Female: 0 mgIKg , 2 mgIKg, 5 mglKg
and 10 mglkg body weight.
ACECLOFENAC TABLETS lOOmgo_KUSlhlf
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Jadavpur UniverSity, Kolkata - 700 032
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METHODS
Randomization, Numbering and Grouping of Animals
Forty eight rats i.e. 24 male and 24 female healthy rats were divided into four groups of6 rats
; ..r .. g +l.e {\ ........fKg 2 ..."gIK.... ;;:: mgIK"'" 1 {\
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rnglkg Animals were allowed acclimation period of 7 days to laboratory conditions prior to
the initiation ofdosing . Rats were assigned to six per cage sex wise and the individual animal
was fur marked with picric acid. The females were nulliparous and not pregnant.
Route of Administration: OmI (gavages).
Justification for selection of Wister Strain Rats for the Study
1) One ofthe rodent species recommended as test system for the use in toxicity studies,
2) This test system has been demonstrated to be sensitive to toxins,
3) Widely used throughout indilstryfor the evaluation oftoxicity ofvarious products,
4) Historical data and evidence at the facility.
Route ofAdministration and Reason for Choice
Oral, fOT 28 days. The oral route was selected for use because,
I) The dosage can be accurately administered,
,-,
2) _One ofthe proposed routes for toxicity testing,
Oral route is considered to be a potential route ofhuman exposure.
DOSE PREPARATION
ACECLOFENAC TABLETS lOOmg. suspended in water was administered to rats at the
dose levels of 2 rngIKg, 5 rngIKg and 10 rnglkg in the dose volume of Im1J 100g body
. weight. The test article suspensions were freshly prepared every day for 28 days. The control
animals were administered vehicle only.
ACECLOFENAC TABLETS lOOmg__KUSUM

9


OBSERVATIONS
Symptoms
I

All animals were obsefved daily for clinical signs.- The time of onset,1 intensity and duration
I
of these symptoms, ifany, were recorded.
Mortality
I
All animals were observed twice daily for mortality during the period the study.
I
Body . . . .' . I

The weIght of each rat was recorded on day 0 and at weeldy mterval, throughout the course
of the study. The groups: mean body weights were calculated. I
/-,
Food consumption I
I
The quantity of food consumed by groups consisting of six rats eac* ,vas recorded weekly
and the food consumption per rat was calculated for comrol and dose droops.
TERMINAL STUDIES I
Laboratory Investigations I
I
Following laboratory investigations were carried out prior to sacrifice on completion of
dosing period of 28 days in animals fasted over-night Blood samPlf were collected from
orbItal smus followmg mommg usmg hepann as antIcoagulant. I'
Haematological Investigations' . I
Following haematological parameters were studied using MEDONIC 620 Cell Counter.
Hb : Hemoglobin (g%) RBC : Red Blood Corpuscles (x10
6
/ cmm)

Rt. : Reticulocyte (%) MCV : Mean Corpuscu1!ar Volume ( 11m3)
HCT : Hematocrit (%) MCH : Mean Corpusculal Hemoglobin (pg)
Platelets: (x 10
5
/cmm) MCHC : Mean Corpuscn1ar Hemoglobin Concentration (010)
N : Neutrophils (%) WBC : White Blood Cocpuscles (x 1if /cmm)
L : Lymphocytes (%) E : Eosinopmls (%)
M : Monocytes (%)
10

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Biochemical investigations
Following biochemical parameters were studied using MlCROLAB-300.
TOTAL SERUM PROTEIN (g01o)
BUN: Blood Urea Nitrogen (mg'lo)
SGPT: Serum Glutamic Pyruvic Transaminase (lUlL)
SGOT: Serum Glutamic Oxaloacetic Transaminase (lUlL)
SAP: Serum Alkaline Phosphatase (lUlL)
BLOOD SUGAR (mg'lo)
Necropsy
All animals were sacrificed on day 29, using cervical dislocation technique.
Necropsy of all animals was carried out and the weights ofthe following organs were
recorded: Liver, kidneys and heart. The organ weights were recorded as absolute values and
their relative values (i.e. per cent of the body weight) were calculated.
Histopathology
Following tissue samples of organs from control and animals treated at the highest dose level
of 10 mg/kg were preserved in 10% fonnalin for histopathological examination.
Adrena1s; Heart; Kidneys; Liver; Lungs; Stomach;
Adrenals, Heart;. Kidneys, Liver, Lungs and Stomach oflow and intermediate dose group
animals were preserved for possible histopathological examination, in case the'
histopathological examination ofhigh dose group animals is indicative of abnormalities
associated with the treatment.
ACECLOFENAC TABLETS 100mg._KUSUM
11
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Department ofPharmaceutical Technology.
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Tel: (033) 24146967 Fax: (033) 24146186/6266 1509001:2000 Certlfed
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RESULTS
Clinical signs (Table B)
Male-
Group I (0 mglkg) : Animals were free ofintoxicating signs throughout the dosing period of
28 days (animal nos. 1 to 6).
Group n (2 mglkg) : Animals were free of intoxicating signs throughout the dosing period of
28 days (animal nos. 13 to 18).
Group III (5 mglkg) : Animals were free of intoxicating signs throughout the dosing period
of28 days (animal nos.25 to 30)..
Group IV (10 mglkg) : Animals were free of intoxicating signs throughout the dosing period
of28 days (animal nos.37 to 42).
~ /
Female
',,--"e'
Group I (0 mglkg) : Animals were free ofintoxicating signs throughout the dosing period of
28 days (animal nos.7 to 12).
Group n (2 mglkg) : Animals were free of intoxicating signs throughout the dosing 1 period
of28 days (animal nos. 19 to 24).
Group III (5 mglkg) : Animals were free of intoxicating signs throughout the dosing period .
of28 days (animal llos.31 to 36).
Group IV (lO mglkg) : Animals were free of intoxicating signs throughout the dosing period
of28 day'S (animal nos.43 to 48).
Mortality (Table C)
. Male and Female All animals from control and different dose groups survived through the
dosing period -- 1 of 28 days.
ACECLOFENAC TABLETS lOOmgo_KUSlIM
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BODY WEIGHT (TABLE D; APP.I; FIG.I & m
MaIe-
Animals from control and the different dose groups exhibited' nonna!. body weight gain
throughout the dosing period of28 days.
Female

Animals from control and the different dose groups exhibited normal body weight gain
FOOD CONSuMPTION (TABLEE; FIG.ill & IV)
Male and Feinale
During the dosing period and at termination the quantity of food consumed by animals from
'-",
different dose groups was found to be comparable with that by control ammals.
HAEMATOLOGICAL INVESTIGATIONS (TABLE F; APP.II)
Male and female - at termination of dosing on day 29, no significant changes were observed
in the values of different parameters studied when compared with controls and values
obtained were within normal biological and laboratory limits.
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BIOCHEMICAL INVESTIGATIONS (TABLE G; APP. llI)
Male and Female...;.
At termination-on day 29, allbiocbemica1 parameters studied ie. Total scnnn protein, SGPT,
SOOT, SAP, BUN and BLOOD SUGAR were found to be comparable with controls and
were within the normal biological and laboratory limits.
ORGAN WEIGHTS (TABLE H & 1; APP. IV, V)
Male and Female
/-...
Animals from control and the different dose groups exhibited nonna! body weight gain
ACECLOFENAC TABLETS
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Jadavpur University, Kolkata - 700 032 . : :
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Tel.' (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000 Certllied
NECROPSY (TABLE J; APP.VI)
Summary ofnecropsy findings in male and female animals is described in Table 1. The gross
pathological examination revealed no abnormality attributable to the trea1nlent.
mSTOPAmOLOGY (TABLE K; APP.VI)
Summary of histopathological observations is given in Table no.K. The histopathological
observations on individual. animal given in App.Vl.
Histopathological examination ofanimals from high dose group revealed no abnormality
attributable to ,the treatment.
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Jadavpur University, Kolkata - 700032
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Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000 CerUfied

'--,. SUB CHRONIC ORAL TOXICITY STUDY OF
ACECLOFENAC TABLETS lOOMG ..

IN RATS
FIG NO. I: MALE (RAt) GROUP MEAN BODY l
132 WF...JGBT (g) I
I

<.;JJ 130
f-o
r
S
,. 128
><
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t:Q
126

124

o 7 14 21 28
DAYS
Ong/kg -lE-2mg/kg ----5 ng/kg --*- 10 rug I kg
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Jadavpur University, Kolkala - 700032 . rw[t1
Tel: (033) 24146967 Fax: (033) 2414618616266 /SO 9001:2000 Ce:tified
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SUB ,CHRONIC ORAL TOXICITY STUDY OF
ACECLOFENAC TABLETS lOOMG. '
IN RATS
FIG NO. D: FEMALE (RAT) GROUP MEAN BODY
WEIGIIT(g)
132.-----------------------------------------
130
UJJ
f:-<
I

128
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Cl
0
126

124

o 7 14 21 28
DAYS '
1--1
I 0 mg/kg 2 mg/kg 5 mg/kg --10 mg/kg-J
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SUB CHRONIC ORAL TOXICITY STUDY OF
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ACECLOFENAC TABLETS lOOMG.
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FIG NO. m: MALE (RAT) GROUP MEAN FOOD

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CONSUMPI10N (gIanimal)
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DAYS
--Orng/kg -5mg/kg
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ACECLOFENAC TABLETS lOOmg'!-KUSUM
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Tel.' (033) 24146967 Fax.' (033) 2414618616266 ISO 9001:2000 Certified
SUBCBRONIC ORAL TOXICITY STIJDY OF
ACECLOFENAC TABLETS .
lNRATS
FIG NO. IV: FEMALE (RAT) GROUP MEAN FOOD
CONSUMPTION (gIanimal)
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06
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(./2
6 5
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DAYS
-t;-Omg/kg __ 2mg/kg -5mg/kg -M-IOmg/kgl
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ACECLOFENAC TABLETS lOOmg._KUSDM
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Department o/Pharmaceutical Technology,
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Jadavpur University, Kolkala - 700 032
Tel.' (033) 24146967 Fax (033) 24146186/6266
ISO 9001:20lI0 CertifN!d
<---""
SUB CHRONIC ORAL TOXICITY REPORT
TABLE NO. A
ALLOCATION OF ANIMALS TO VARIOUS GROUPS
r- No. of Animals 11
Dose (mglkg) I .. Sex Animal Numbers
Group No.
, I . each group .
I Male 6' 1-6
I Control !
I Female 6 7-12
I I Male 6 I 13-18
n I 2
Female 6 I 19..24
I
Male 6 25-30
5
_111______ Female 6 31-36 I
Male 6 -I 37-42 1
---,-__Fe_male 6 I 43-48 _ ... ==1

10
ACECLOFENAC TABLETS
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Jadavpur University, Kolkala - 700 032 .
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Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9IJO:f:20oo Certified
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. TABLENO.B
EFFECT OF DRUG TREATMENT ON CLl'UCAL SIGNS OF INTOXICATION
Sex: Male
.-,
. T tal Period of
Dose
Observed Nun::,... of Anima1 signs in I Moi1a!ity
-r .. r::r
o.
F;N
(mglkg)
SIgns Animals. Nos. days I
from-to
I
0/6 1-28 1-6 I Control NIL 6
,
1 -28 6 13-18 0/6 II

Nil.
2
0/6
.
25-30 1-28 III 6 Nil.
5
0/6 37-42 1-28 6 IV NIL
10
---- ..
/--.',
Sex: Female

Period of
Total
Dose Observed signs in Animal
Group No. Number of Mortality
(mglkg) Signs Nos. days
Animals.
from-to
I
- ---- ,---
Control 7-12 1-28 0/6 NIL 6

II 6 19-24 NIL 0.16
2
-c--- ._-r-----
III NIL 6 31-36
5
IV NIL 6 43-48 0/6 ::: 1-
0/6
I
10
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ACECLOFENAC TABLETS 100mg'!-KUSlJ.M
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Jadavpur University, Kolkata - 700 032
Tel: (033) 24146967 Fax: (033) 2414618616266
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TABLE NO.C
MORTALITY .
Under the conditions ofthe present study, the following mortality rates were
recorded:
Dose (mglkg) , Mortality
Body weight Group Males Females
No. Relative. Relative
Male Female Absolute Absolute
% %
0/6 I 0/6 Controf Control 0 0
IT 0/6 0/6 0 0
2 2
- t----
1lI
--
0/6 0/6 0 0
5 5
0/6 IV 0 0/6
10 lO
1
ACECWFENAC TABLETS
21
Jadavpur University, Kolkata - 700032 '

TABLENO.D
GROUP MEAN BODY WEIGHT (g)
Sex- Male
Gr. No.
I
1----
n
I
ITI
IV
Dose Day
mglkg' 0 7 21
Mean
127.50 127.88 127.82 128.83
Control
!-
------
SD
2.25 1.89 1.95 2.10
Mean
__ 127.52 127.60 127.42
2
SD
2.24 2.38 1.87 2.45
---
Mean
127.32 127.77 128.57
5
128.18
SD
2.55 2.39 2.59
--
Mean
126.87 ' 127.85 . 128.10
10
r---'
---- -
SD
2.15 2.22 1.92 2.04
--
28
129.87
1.92
--
128.85
2.21
129.92
----,:'-------
2.62_
129.40

/--.....'\
Sex- Female
/

Dose
Gr. No.
mg/kg
I Mean
Control
SD
Mean
II
2
----

SD
Mean
5
--
SD
Mean
IV
10
SD
'----- --
' Day
0
'7
"
21
.... 0
I 1"',
126.02 126.58 126.30 127.27 127.98
--- --- ---
2.14 1.33 1.81 1.97 2.29
126.95 127.62 127.27 128.05 129.07
----
2.38 1.87 2.04
--
2.47 2.40
-,'
,
126.53 126.85 127.20 127.73 128.73
---
2.15 1.54 2.08 1.77 1.47
- 1-- --
127.50
2.33
127.80 128.60 128.85 129.95
1.68 1.56 2.25 2.28
ACECWFENAC TABLETS lOOJiJl__KUSDM
22
-------
-------
-------
IruvlQ
TABLE NO. E
GROUP MEAN FOOD CONSUMPTION (g/ animal)
Sex- Male
Or. No.
Dose Day
mglkg 0 7 14 21 28
I Control Mean
5.24 .5.49 5.68 5.87 6.06
II
2
Mean
5.13 5.29 5.43 5.61 5.82
ill
5
Mean
4.92 5.09 5.18 5.31
-
5.47
IV
10
Mean
5.11 5.21 5.37 5.48 5.62
Sex-Female
," - - . ~ ,
Or. No.
I
II
ill
IV
. ' . ~ ,
rc..
~ - ,
Dose
-
mglkg 0
Control Mean
5.31
Mean
2
4.91
Mean
5
5.12
Mean
10
5.08
7
5.59
5.18
5.29
5.17 .
Day
14 21 28
6.07 i 5.78 5.93
5.46 5.69 5.37
5.79 I 5.48 5.61
5.58
I
5.26 5.42
ACECLOFENAC TABLETS lOOmg",-XUSUM
23

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GROUP MEAN - HAEMATOLOGY.
Sex-Male
, ............'\
\--/
,---'"<,\
'- ,/
I i
Total
Gr. I Dose ! Hb RBC Rt HCT MCV
No. I mglkg I
(g%)
(x 10
6
(%) (%)

/cmm)
T
I I Mean 15.17 6.42 2.08 44.13 69.44 1
I. Control ! SD
0.84 0.67 0.44 1.89 8.30
I
2
I Mean 15.22 6.33 2.22 45.17 71.75
II t SD 0.97 0.59 0.33 1.79 6.35
5
Mean 15.30 5.92 2.13 44.28 75.26
ill
.
SD 0.84 0.44 0.36 2.20 7.36
IV
I
10
i Mean 15.48 6.37 2.12 45.77
SD 1.18 . 0.76 0.40 4.44 8.05
.. ----- ------ ----
MCH
(pg)
23.83
2.55
24.20
2.85
25.99
2.43
1
24
.
52
2.47
MCHC
(%)
34.36
0.82
33.67 .
1.16
34.55
0.74i
33.90
----
1.26
..
Gr. No
Dose
mglkg
------
Mean
Platelets
(x 10
5
/cmm)
Total
WBC
(xl<f
/cmm)
Differential %
N L E M
------
0.83 I
Control
5.03 6.00 23.50 73.67 2.00
SD 0.77 0.87 1.87 2.07 0.89 0.75
II
" -- ._.
ill
2
1--
5
Mean 5.37 6.20 24.33 72.. 17 2.50 1.00
SD 1.00 0.68 2.16 1.94 1.05
._.
2.:::'7

0.67 Mean 5.10 6.08
,
23.33 . 73.83
SD 1.03 0.85 2.16 2.48 0.75 0.52
IV 10
Mean 5.47 5.98 22.50 74.00 2.33 1.17
SD 0.94 0.89 2.43 3.58 1.21 0.75
i
I
Hb: Hemoglobin RBC: Red Blood Corpuscles
Rt: Reticulocyte
HCT: Hematocrit MCV: Mean Corpuscular Volume
MCH: Mean Corpuscular Hemoglobin MCHC: Mean Corpuscular Hemoglobin Concentration
.WBC: White Blood Corpuscles N: Neutrophils
L: lymphocytes E : Eosinophils
..../
.M: Monocytes
ACECLOFENAC TABLETS lOOmg__XUSUM .
24
'L-/
---/
Jadavpur University. Kollulta - 700 032 .
_ .....:.

Tel: (033) 24146967 Fax.' (033) 2414618616266 ISO 9001:2000 Certified
TABLE NO. F (Conti)
GROUP MEAN - HAEMATOLOGY
---,,/ Sex- Female
r

Total
Gr, Dose Hb RBC Rt HCT MCV
No, mglkg (g%)
(x 100
/cmm)
(%) (%)
Jllll3
I
Control
Mean 15.18 6.27 2.0L 44.92 72.00
f---
SD 0.89 0.56 0.47 1.78 4.92
2
Mean 15.40 6.32 2.12 44.70 71.67
H SD 0.84 0.76 0.27 1.66 9.43
- --
5
Mean 15.45 6.37 2.18 45.65 72.07
---
TIl SD 1.06 0.62 0.55 3.86 7.02
IV 10
Mean 15.22 5.92
44,23 75.01.
SD 1.01 0.29 0.44 2.12 6.64
--
--
MCH
(pg)
24.34
1.99
24.66
3.11
24.41
2.32
25.82
2.79
MCHC
(%)
33.80
1.22
34.44
0.84

33.88
0.63 .

Gr. No
Dose
mg!kg
--
Control
Mean
Platelets
(xHY
/cmm)
. Total
WBC
(x 1dl
/cmm)
Differential %
N L E M
I 5.28 6.25 24.50 72.17 2.33 1.00,
SD 1.00 0.63 1.87 2.48 0.82 0.89
II
2
Mean 4.88 6.03 23.50 72.83 2.50 1.17
SD 0.46 0.77 1.87 1.94 1.05 0.75
HI
5
r-
Mean 5.17 5.85 23.67 73.50 2.00 0.83
!
--
SD 0.84 0.81 2.16 2.43 0.89 0.75 -
IV 10
Mean

SD
5.43 5.98 22.33 74.83 0.67
1.08 0.56 2.16 2.23 0.75 I 0.52
Hb: Hemoglohin RBC: Red Blood Corpuscles
Rt: Reticulocyte
HCT: Hematocrit - MCV: Mean Corpuscular Volume
MCH: Mean Corpuscular Hemoglobin MCHC: Mean CorpuScular Hemoglobin Concentration
, WBC: "''bite Blood Corpuscles N : Neutrophils
L: lymphocytes E : Eosinopbils
'M: Monocy1es

ACECLOFENAC TABLETS lOOmg,!-KUSUM
25
/..-..........
\ ... j
OfJ:.m
I ~
Tel: (033)24146967 Fax: (033) 2414618616266
ISO 9001[:2000 Certified
TABLE NO. G
GROUP MEAN - BLOOD CHEMISTRY
Sex-Male
, ~
\----./
Total
Gr. Dose Serum BUN SGPT SOOT
No. mg/kg Protein (m!flo) (lUlL) (lUlL)
(g%)
f----- f--------
I
Control
Mean 6.20
. 26.33 _ 47.17 92.50
SD
0 . 6 ~ 3.33 3.76 5.39
2
Mean 5.78 27.00 48.50 95.33
II SD 0.32 2.83 3.51 2.58
5
Mean 6.22 28.00 47.17 95.83
III SD 0.79 2.83 4.88 4.26
----,- - ---------
N 10
Mean 6.03 26.17 46.83 94.17
SD .. _. ____ 0.60 2.86
I
3.31 4.54
-----
Blood
SAP
(lUlL )
Sugar
(mg%)
__ I
299.67. - 90.67
--- --
46.10 5.13
322.33 94.83
48.36 5.42
313.00 95.67
,
64.54 4.23
311.50 95.33
74.78 4.50 i
Sex- Female
'-j
Total
Gr. Dose Serum BUN SGPT SOOT -
No. mg/kg Protein (mgolo) (lUlL) (lUlL)
--- ---
(g %1
-------- 0-
I
Control
- Mean 6.02 26.67 48.83 94.00
---
SD 0.52
. 3.14 2.86 4.86
2
Mean 6.03 27.00 46.83 94.67
II SD 0.78 2.83 3.31 3.61
5
Mean 5.90 26.67 46.33 95.33
m SD 0.91 2.50 4.18 5.16
IV 10
Mean 6.07 25.00 46.50 95.50
SD 0.69 2.37 4.51 5.39
--
--- ---
Blood
SAP
(lUlL)
Sugar
(m!flo)
,
--
1----'--
303.50 98.00
48.36 2.83
294.33 95.50
53.98
4.09 .
317.83 96.50
41.69 3.62
---
302.67 94.83
44.53 4.17
ACECLOFENAC TABLETS lOOmg__KUSllM
26
----------
/,
1
STUDY CENTRE
Department o/Pharmaceutical Technology. .
IruvS
Jadavpur Unh+rsity. Kolkata - 700 031
Tel: (033) 2414696
1
Fox: (033) 24146186/6266 ISO 9001:2000 Certlfied
TABLENO. H
I
GROUP 1AN ABSOLUTE VALUES (G)
Sex: Male
Body
Dose Heart Kidneys .
Weight Gr. No.
(g)

(g) mglkg
(g)
I Mean 4.89 0.77 0.49 1129.87
Control
SD 0.56 0.05 1.92 0.06
Mean 128.85 4.97 0.76 0.50
2
2.21 0.55 0.05 0.05
f-..
II SD
Mean 129.92 5.02 0.50 0.78
5
III 0.66 0.07 2.62
...
Mean 129.40 5.06 0.79 0.51
IV 10
SD 1.53 0.64 0.06 0.06
Sex: Female
Gr. No.
/ I
II
III
IV
/.
,,_./
Dose
mglkg
Body
Weight
(gL
Liver
(g)
Kidneys
(g)
Heart
(g)
Control
Mean
SD
127.98
2.29
4.85
0.59
0.78
0.05
0.49
0.06
2
Mean
SD
129.07
2.40
5.04
0.41
0.79
0.05
0.51
0.04
5
Mean
SD
128.73
1.77
5.09
0.48
0.78
0.05
0.51
0.05
...
10
Mean
SD
1129.95
1
2.28
5.03
0.60
0.78
0.06
0.50
.
0.06
ACECLOFENAC TABLETS 100mg__KUSUM
27
(;-
'\
_.__..
-..
----
---- --
--
--------
------
,...... --.\
/-"
Department ofPharmaceutical Teclmology,
Jadavpur University. Kolkata - 700 032 .
. : IRiVlQ
a.ot
r
~ /
TABLE NO. I
GROUP MEAN RELATIVE VlUlJES (%)
Sex: Male
Gr. No.
Dose
mglkg
Ilrvl.. ,
..IJVU;Y
Weight
(g)
Liver
Kidne:ys Heart
I
Control.
Mean 129.87 3.77 0.59 0.38
SD
---
1.92 0.44 0.04 0.04
II
2
Mean 128.85 3.86 0.59 0.39
SD 2.21 0.43 0,04 0.04
--
III
5
Mean 129.92 3.87 0.60 0.39
SD 2.62 0.51 0.04 0.05
IV 10
Mean
SD
129.40
1.53
3.91
0.52
0.61
0.05
0.37
0.()5l
\:.,
Sex: Female
Gr. No.
I
~ - - -
II
III
IV '., ,.,i
Dose
mglkg
Control
2
J:;
..,
10
Mean
SD
Mean
SD
Mean
~ - - - - -
SD
Mean
SD
Body
Weight
(g)
127.98
~ - - - - -
2.29
129.07
2.40
128.73
1.77
129.95
2.28
Liver
3.78
0.40
3.91
0.37
3.95
0.39
4.04
0.42
Kidneys
0.61
0.00
0.61
0.05
0.61
0.04
0.60
0.05
Heart
0.38
0.04
0.39
0.04
0.40
---
0.04
0.39
0.05
r
28
--',
IJiiVlQ
' . OfAOft=
TABLE NO. J
SUMMARY OF GROSS PATIIOLOGY FlNDINGS'
Sex: Male
j . Group I II HI
.. L_
Site and lesion observed
1-6 13-18 25-30
NAD
IV
37-42
Sex: Female

"

Site and lesion observed Group I II HI
7-12 19-24
NAD
'---..
IV
43-48
NAD = No Abnormality Detected
ACECLOFENAC TABLETS 100mgo_KUSUM
29
.....''-..'\
'J

/r-Q
Jadavpur University, Kolkata - 700 032 ' : :
g.waHI
TABLE NO.K
,'--"
SUMMARY OF mSTOPATHOLOGY FlNDINGS
Sex: Male Fates: All
Days: All
Group Omglkg lOmglkg
Number of Animals 6 6
#SEV #SEV
Heart #Ex 6 6
Kidneys #Ex 6 6
Liver #Ex 6 6
'--',
Lungs
Stomach
#Ex
#Ex
6
6
6
6
Severity calculated by the number oftissues examined
.6= normal
7= mildly abnormal
8"" severely abnormal
ACECLOFENAC TABLETS
30
"
"
1iN
'
8
Jadavpur University, Kolkala - 700 032
/

TABLE NO.K (Contd.)
'\
SUMMARY OF mSTOPATHOLOGY FINDINGS

./
Sex: Female Fates: All
Days: All
Group Omglkg 10 mglkg
Number ofAnimals 6 6
#SEV #SEV
..,
. 6 .
Heart #Ex 6
Kidneys #Ex 6 6
/" "'.
,
Liver #Ex 6 6
Lungs #Ex 6 6
Stomach #Ex 6 6
Severity calculated by the number oftissues examined
"
6= normal
7= mildly abnormal
8= severely abnormal
'.
31
(
-----
------
---
---
~
~
Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000 Cer'Jfied
APPENDIX NO It
INDIVIDUAL ANIMAL BODY WEIGHTS (g)
Sex: Male
Group: I
Dose: Control
AnrmalNo.
Day
0 7 14 21
t
124.3 125.7 124.9 125.6
127.5 128.3 127.4 128.4
125.7 126.8 127.3 128.5
I ~ I
129.3 130.4 129.7 130.5
127.8 126.4 127.3 128.3
130.4 129.7 130.3 131.7
28
I
126.7
129.5
!
129.7
131.2
129.7
132.4
I
APPENDIX NO h
INDIVIDUAL ANIMAL - BODY WEIGHTS (g)
Sex: Female
Group: I
/
Dose: Control
~ - - - - - -
Day
Animal No.
7 0 14 28 21
i
7 126.3 127.5 126.4 127.3 128.2
...
is 123.5 124.7 125.4 124.8 125.1
I
-, 9 127.3 126.4 127.3 128.4 129.1
10 124.3 125.7 _126.4 124.2 125.8
--- ..
11 129.4 128.5 129.3 130.4 131.7
I
--
12
I
125.3 126.7 125.2 126.9 127.4
ACECLOFENAC TABLETS lOOmg._KUSllM
32'
-----
-----
--
-------
~
~
Tel: (033) 24146967Fax: (033) 2414618616266
, ~
APPENDIX NO 13
-,
Sex: Male
--,/
Group: II
Dose: 2mglkg
Animal No.
13
14
15
0
128.7
125.7
129.3
7
129.4
126.8
130.7
Day
14
128.6
125.4
129.4
21
129.3
126.9
130.6
28
130.7
127.3
131.7
16
17
18
'----
126] 125.3 127.8 124.8 125.2
129.7
--
128.3 129.7 127.6 128.3
123.7 124.6 125.8 124.2 1 2 5 ~
APPENDIX NO 14
Sex: Female
Group: II
Dose: 2mgtkg
I ~
I U 1"f L.l L.o
19 123.5 124.7 125.8 125.9 124.3
20 127.4 128.3 127.2
--
129.2 128.4
21 125.4 125.2 126.3 126.7 127.5
22 128.3 129.4 _13G.7 128.5 129.4
23 130.4 132]
--
129.5 130.7 131.6
f---------------
126.7
I- 127.5 24
-
126.2
--
127.9 128.4
'-'--------- -
I
ACECLOFENAC TABLETS lOOmg__KlTSUM
33
/ "',
,,--,\.
------ ------
-----
----
"
.... : /ruit1
QtIII_on
Tel: (033) 24146967 Fax: (033) 2414618616266
APPENDIX NO Is
.--\
Sex: Male
Group: III
Dose: 5 g!k:g
Day'
Animal No. f--
7 14 21 28
-
0
f--
130.7 128.4 129.2 127.5 25 126.3
r:--
125.9 124.7 125.4 124.3 26 123.8
129.4 131.7 128.5 130.1 27 129.3
!------- 28 127.4
126.1 125.1 126.8 125.4
130.4 129.5 131.7 129.4 29 128.7
30
---
129.8 130.4 131.5 132.1 130.4
--
~ - " " ' ,
APPENDIX NO 4
INDIVIDUAL ANIMAL - BODYWEIGHTS (g)
Sex: Female
Group: III
Dose: 5 g!k:g
Day
Animal No. r
0 7 14 28 21
f---------- !--
31 128.2 127.1 128.5 129.4 130.3
125.8 126.4 125.7 32 126.3 127.4
33 129.4 128.4 129.3 130.7 131.1
125,3 34 124.8 126.7 126.9 125.1
35 127.3 128.4 127.3 128.1 129.4
36 123.7 124.9 125.7 126.8 127.3
ACECLOFENAC TABLETS lOOmg___KUSUM
( ~
34
----
-----
--- ------
Department ofPharmaceutical Technology. .
~
Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000Certified
APPENDIX NO 17
INDIVIDUAL ANIMAL BODY WEIGIITS (g)
~ ,
Sex: Male
Group: IV
~ " - -".,
Dose: 10 mglkg
,--
Day
Animal No.
14 28 21 0 7
r--
37 131.2 129.3 130..7 130.4 129.4
128.8 125.3 126.1 38 124.2 127.2
---
127.3 129.5 128.4 128.9 39 127.2
. 125.4 127.9 126.3 127.1 126.5 40
131.2 131.4 130.7 41 129.3 130.4
i---
126.3 127.4 126.2 127.8 42 125.7
APPENDIX NO Is
1NDIVIDUAL ANIMAL - BODY WEIGIITS (g)
Sex: Female
Group: IV
Dose: 10 mglkg
Day
Animal No.
7 14 21 0 28
126.8 127.4 43 125.3 126.3 127.4
44 128.3 129.4 128.2 129.5 130.7
45 124.6 125.3 126.7 127.2 128.1
46 129.6 128.4 130.5 131.7 132.1
r
47 126.8 127.2 128.4 127.3 128.5
48 129.7 130.4 131.1 132.9 ____ 1304
35
."
----- ----
----
'.../
[TINS]
: :
;1M."
. Tel: (033) 24146967Fax: (033) 2414618616266 ISO 9001:2000 Certified
APPENDIX NO. III
.INDIVIDUAL ANIMAL - HAEMATOLOGY
Sex-Male
Group: I
Dose: Control
r--_.
Animal
No.

."-'"',
1
2
3
4

Animal
No
I
2
3
4
5
6
L ...
lIb
(gOA,)
15.3
14.8
.15.1
14.9
16.7
14.2
Platelets
(x 10
5
/cmm)
4.7
5.2
6.1
4.2
5.7
4.3
lIb : Hemoglobin
Rt: Reticulocyte
HCT : Hematocrit
TotalRBC
MCH MCHC MCV Rt I HCT
(x 10
6
J.IlIl3 (%) (%) (pg)
(%) I
/cmm)
,
5.9 1.8 45.1 25.9 33.9 76.4
63.1 2.4 42.3. 35.0 6.7 22.1
5.4 1.6 44.7 33.8 82.8 28.0
._ ..-.
6.9
7.2
6.4
Total
WBC
(x 1<Y
/cmm)
5.2
6.7
7.2
4.9
6.1
5.9
42.8 2.3 21.6 . 34.8 62.0
47.2 2.7 65.6 23.2 35.4
1.7 42.7 22.2 33.3
!
66.7
Differential %
N L E
70 26 3
75
._.
22 1
24 74 2
73. 25 1
21 76 2
23 74 3
I I I
RBC : Red Blood Corpuscles
MCV : Mean Corpuscular Volume
M
1
2
0
1
1
0
I
MCH : Mean Corpuscular Hemoglobin MCHC: Mean Corpuscular Hemoglobin Concentration

WBC : White Blood Corpuscles : N eutrophils
L : lymphocytes E : Eosinophils
M : Monocytes
ACECWFENAC TABLETS
36
,--.,
----------- ----
--- -------
-------
-------
-------
""
"---..-.'
. Department ofPharmaceutical1echnology.
:: :
QM:l-Cfn
I ~
Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000 Certlrled
APPENDIX NO. 112
Sex Female
INDIVIDUAL ANIMAL HAEMATOLOGY
Group: I
Dose : Control
Hb Animal
""
(!fib) No.
7 .15.3
14.2 8
16.8 9
14.7 10
15.3 11
12 14.8
TotalRBC
(x 10
6
Icmm)
6.4
5.7
6.2
5.9
7.3
6.1
Rt HCT
(%) (%)
45.1 2.8
1,6 43.7
47.2 2.2
1.8 42.2
2.4 46.2
1.7 45.1
MCV
f.lIIl3
70.5
76.7
76.1
71.5
63.3
73.9
MCH MCHC
(pg) (%)
33.9 23.9
24.9 32.5
I
27.1 35.6
i
24.9
~ 4 . 8 1
21.0 33.1
i---
24.3 32.8
Animal .
No
Platelets
(x 10
5
Icmm)
Total
WBC
(x 10
3
Icmm)
Differential %
N L E M
7 5.8 6.1 22 75
?
0
8 4.9 5.8 26 72 1 1
9
10
5.7
4.3
6.3
5.4
25
23
71
74
2
3
2
0 !
11 6.8 7.1 24 73 2 1
12 4.2 6.8 27 68 3 2
I
\.,
Hb : Hemoglobin RBC : Red Blood Corpuscles
Rt Reticulocyte
. , ~ .
HCT : Hematocrit MCV : Mean Corpuscular Volume
MeH : Mean Corpuscular Hemoglobin MCHC: Mean C()lJ>uscu1ar Hemoglobin Concentration
. WBC : White Blood Corpuscles N : Neutrophils
L: lymphocytes E : Eosinopbils
M : Monocytes
ACECWFENAC TABLETS l00mgo_KUSUM"
37
Jadavpur University. Kolkata - 700 032 '
.: ;
OMS-DOl
~
APPENDIX NO, ll3
Sex- Male
INDIVIDUAL ANIMAL - HAEMATOLOGY
Group: n
Dose: 2mg/kg
Animal
No.
Hb
(g01o)
TotalRBC
(x 10
6
/cmm)
Rt
(%)
HCT
(%)
MCV
tJIIl3
MCH
(pg)
MCHC
(%)
33.1 13 14.3 5.8 2.2 43.2 74.5 24.7
-4
,--,1
,15.2 6.2 2.4 45.7 73.7 24.5 33.3
15 16.8 5.7 1.9 46.8 82.1 29.5 35.9
16
--
14.7 6,6 2.7 45.2 68.5 22.3 32.5
17 15.9 7.3 1.8 47.2 64.7 21.8 33.7
-----
33.6 18 14.4
-- -
I
6.4
--
2.3 42.9 67.0 22.5
----
Animal
No
Platelets
(x 10
5
/cmm)
Total
WBC
(x 1<Y
/cmm)
N
Differential %
----
L E M
13 5.,3 6.3 27 70 2 1
,--14 4.7 5.4 24 '
,--'-----
70
4 2
15 6.2 6.8 23 73 3
----
-
1
_I
16 4.3 7.1 26 73 1 0
17 6.9 5.5 21 75 3 1
J
18 4.8 6.1 25 72 2
LJ
- Rt: Reticulocyte
HCT: Hematocrit MCV : Mean Corpuscular Volume
"
'-..'
MCH : Mean Corpuscular Hemoglobin MCHC: Mean Corpuscular HemoglObin Concentration
WBC : White Blood Corpuscles N : Neutrophils
. L : lymphocytes
E : Eosinophlls
M : Monocytes
38 '
'-J
--
---
- -
-----
--
Jaciavpur University, Kolkala - 700 032
.;' :: Ir.aS
0 1102
APPENDIX NO. 14
Sex- Female
Group: n
Dose: 2mg/kg
TotalRBC
Rt Animal Hb
(x 10
6
(%) (gOA No.
/cmm)
2.3 16.8 6.7 19
~ -
f---
- ~ ,
1.7 15.2 5.4 20
6,2 2.1 21 14.9
15.7 1.9 7.3 22
23 14.3 6.8 2.4
24 15.5 5.5 2.3
--
HCT MCV MCH
J1Ill3
(pg) (%)
47.3 70.6 25.1
45.1 83.5 28.1
42.9 24.0 69.2
44.7 61.2 21.5
42.9 63.1 21.0
45.3
--
28.2 82.4
MCHC
(%)
35.5
33.7
34.7
35.1
33.3
34.2
Differential % Total
Platelets
Animal
WBC
(x 10
5
(x 1<Y No N L E M
/cmm)
/cmm)
I
19
--
4.8 6.2 24 73 1 i
4
26 70 20 5.1 5.1 4 0
2
--
21 74 5.9 3 21 4.2
--
75 1 22 5.6
--
6.3 23 1
71 23 4.7 5.4 25 2 2
1
-
22 74 3 24 4.9 7.3
Rt: Reticulocyte
MCH : Mean Corpuscular Hemoglobin MCHC: Mean COIpuscular Hemoglobin Concentration
WBC : White Blood Corpuscles N: Neutrophils
M : Monocytes
ACECWFENAC TABLETS lOOmgo_KUSUM
39
~ / - " "
-,
----
-------
-- ------- -------
-------

Department 0/Pharmaceutical Technology,
Irdl(t! . .
Jadavpur University, Kolkata- 700 032 '
OMaOO,
APPENDIX NO. ll5
Sex Male
Group: III
Dose: 5 mg/kg
Animal
No.
25
26
","",
27
28
29
30
Animal
No
_.
I
25
L E
72
74
75
71
78
73
2
2
3
2
1
3
i
26
27
28
29
_/' I
30
Hb
(!flo) ,
15.8 '
-16.7
14.5
15.3
'14.9
14.6
Platelets
(x l()i
/cmm)
404
5.2
6.7
4.3
5.9
4.1
... ru-J" RCT
MeV, MCH MCRC
, 3
(pg) (%) )c::) (% ),
.1J.IIl
73.3 " 2.5 44.7 6.1 25.9 35.3
...
5.8 1.8 47.8 28.8 34.9 82.4
604 2.2 42.5 66.4 22.7 34.1
2.4 45.7 26,8 5.7 80.2 33.5
1.6 42.3 6.3 23.7 35.2 67.1

.........
2.3 5.2
_.....
Total
f----.....
WBC
N (x 10
3
/crnm)
5.6 25
7.2 23
22 4.9
5.7 26
6.8 20
6.3 24
42.7 28.1 82.1 34.2
Differential %
M
1
1
0
---
1
..
1
..._.
0
Hb : Hemoglobin
Rt: Reticulocyte
HCT : Hematocrit
--,
Mev: Mean Corpuscular Volume
MCH : Mean Corpuscular Hemoglobin MCHC: Mean Corpusco1ar Hemoglobin Concentration
M : Monocytes
ACECLOFEl\'AC TABLETS lOOmg.-.fiUSUM
40
------
------
------ -----
-----
rw&l
. Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9DD1:2eOO Certified
. APPENDIX NO. I ~
Sex-Female
lNDIVIDUAL ANIMAL - HAEMATOLOGY
Group: TIl
Dose: 5 glkg
._..... . c::.c:-._.
TotalRBC Rt
MCHC HCT MCV MCH Animal fIb
6
. 3
(x10 (o/c)
(%) (pg) (%) (gOlo) No.
!J.IIl /cmm) 0
1.5 31 15.3 7.2 45.7 21.3 33.5 63.5
32 .14.9 6.4 2.7 42.8 34.8 66.9 23.3
6.1 1.9 48.1 33 16.2 33.7 78.9 26.6
34 14.7 5.4 ~ 9 42.9 79.4 34.3 27.2
35 17.2 6.8 2.3 52.1 76.6 25.3 33.0
_ ...
14.4 6.3 1.8 36 42.3 67.1 22.9 34.0
...
Differential % Total
Platelets
Animal
WBC
(x 10
5
No (x 10
3
N L E M
/cmm)
/cmm)
1
6.7 4.8 21 76 31 2
5.3 27 32 5.6 72 0
1
4.8 7.2 25 1 33 71 3
.._ ... ..._ ......
34 5.1 6.2 23 75 1 1
35 5.9 76 4.2 22 2 0
36 24 71 4.9 3 2 5.4 ....
fIb . Hemoglobin
Rt: Reticulocyte
HCT : Hematocrit
MCH : Mean Corpuscular Hemoglobin
WBC : White Blood Corpuscles
L : lymphoc}1es
M : Monocytes
MCHC: Mean Corpuscular Hemoglobin Concentration
N : Neutrophils
E : Eosinophils
41

STUDY CENTRE
Jqdavpur University, Kolkata - 700 032

Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9001:2000 Certllied
APPENDIX NO. II7
Sex Male
Group: IV
Animal
No.
37
---
38
39
r---
40
t----c-:_.
41
42
---
Hb
TotaIRBC
Rt HCT MCV MCH
(g%)
(x 10
6
(%) (%)
J.IlIl3
(pg)
/cmm)
14.7 7.2 2.7 42.1 58.5 20.4
15.2 6.4 1.5 45.8 71.6 23.8
14.8 5.3 2.3 42.6 80A 27.9
17.1 6.8 2.1 53.6 78.8 25.1
14.3 5.6 1.9 42.7 76.3 25.5
-
16.8 6.9 2.2 47.8 69.3 24.3
--
------
MCHC
(%)
34.9
33.2
I
34.7
31.9
33.5
1
35.1
,
\
,
"
Animal
No
Platelets
(x 10
5
/cmm)
Total
WBC
(x 1<f
/cmm)
Differential %
N L E M

1 37 5.9
_ ... _-
6.7
6.7 26 69 4
38 4.8 22 73
3 2
---
0 39 4.5 7.2 19
--
24
80 1
40 6.2 5.3 74 1 1
41 4.4 5.7 23 73 2 2
42 5.1 6.2 21 75 3
1
Rt: Reticulocyte
,.
MCH : Mean Corpuscular Hemoglobin MCHC: Mean Corpuscular Hemoglobin Concentration
. L: lymphocytes E : Eosinopbils
M : Monocytes
ACECLOFENAC TABLETS lOOmg__KUSllM
42

-------
-,
STUDY CENTRE
Department o/Pharmaceutical Technology,
Jadavpur University, Kolhlta - 700 032 .
InwlQ
Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:21lOO Certified
APPENDIX NO. lIs
INDIVIDUAL ANIMAL - HAEMATOLOGY .
Sex Female
Group: IV

I Animal
I No.
43
44
45
46
47

48
Animal
No '--",
43
44
45
46
;,-.."..
47
i
48
i
4.,;1..
Hb
(g%)
15.8
14.1
15.6
14.2
14.9
16.7
Platelets
(x 1<i'
Icmm)
7.1
6.4
4.8
5.1
4.9
4.3
Hb : Hemoglobin
Rt: Reticulocyte
HCT : Hematocrit
TotalRBC
Rt
(x 10
6
(%)
Icmm)
2.5 5.8
6.1 1.8
2.3

6.4 2.8
1.6 .
5.7
2.2 5.6
Total
WBC
(x 10
3
Icmm)
6.1
5.5
6.8
5.3
6.4
5.8
N
25
23
19
22
24
21
M E
0 3
''-----:-
2 1
""----
2 1
1 1
3 0
I
2 1
I
HCT
(%)
45.1
42.3
45.7
42.1
._.
42:9
47.3
MCV MCH MCHC
pm3
(%) (pg)
35.0 17.8 27.2
23.1 33.3 69.3
34.1
i
77.5 26.4
22.2 33.7 65.8
I
26.1 34.7 75.3
84.5 29.8 35.3
1
Differential %
L
72
74
78
76
73
76
MeH : Mean Corpuscular Hemoglobin MeHe: Mean Corpuscular Hemoglobin Concentration
. WBC : White Blood Corpuscles N: Neutrophils
'-..
M : Monocytes
ACECLOFENAC TABLETS l00mgo_KUSUM
43

------
----------
----------

Department o/Pharmaceutical Technology, .

Tel: (033) 24146967 Fax: (033) 2414618616266
ISO 9OO1:2llOO Certified

APPENDIX NO. li
1
INDIVIDUAL ANIMAL - BLOOD CHEMISTRY
Sex-;- Male
Group-I
Dose - Control
Animal
No.
1
2
3
4
5

6
Sex Female
Group-I
Dose - Control
Total
Serum
Protein
. (golo)
6.2
5.8
.' . 6.3
5.4
7.2 .
6.3
Animal
No.
7
8
9
10
I
11
12
. Total
Serum
Protein
(g%)
5.8
6.7
5.2
5.9
6.1 .
6.4
Blood
SOOT SAP
I
[
(mgolo) (lUlL )
25
29
31
27
24
22
45
52
46
42
51
47
(lUlL )
88
94
91
101
86
95
BUN
(mgolo)
29
31
27
25
26
22
Sugar
(lUlL)
(Il1!fIo)
86 268
88 349
91 251
94 275
99 364
291 86
APPENDIX NO. li2
INuivIDUAL ANlMAL - BLOOD CHEMISTRY
SGPT
(lUlL)
48
45
53
49
47
51
SOOT
(lUlL)
98
92
100
87
91
96
Blood
SAP
Sugar
(lUlL)
(mg%)
267 96
98 349
251 99
97 268
103 .
319
95 367
ACECLOFENAC TABLETS
44
.J

Jadavpur University, Kolkata - 700 032 . .' .
Q";o"",'"
~
APPENDIX NO. III3
INDIVIDUAL ANIMAL BLOOD CHEMISTRY
Sex-Male
Group- II , . ~ - - ,
--'
Dose - 2mglkg
,
~ ,
--'
Animal
No.
Total
Serum
Protein
(g%)
BUN
(mgoA,)
SGPT
(lUlL)
soot
(lUlL )
SAP
(lUlL)
Blood
Sugar
(mg%)
13
. 5.8
27 46 92 264 92
14 6.1 32 44 96 359 86
15 5.7 25 49 93 361 94
16 5.5 26 52 99 281 99
17 6.2 28 47 95
---
376 101
18 5.4 24 53 97 293 97
,..-,
Sex Female
APPENDIX NO. lI4
INDMDUAL ANIMAL - BLOOD CHEMISTRY
Group-II
Dose - 2mg/kg
----------
Animal
No.
Total
.Serum
. Protein
(g%)
BUN
(mg%)
SGPT
(lUlL)
SOOT
(lUlL )
SAP
(lUlL )
-----
264
Blood
Sugar
(mg%)
----
92 19
1------------
20
6.2
-----
32
-
46 94
--
5.8 25
-----
47 99 318 97 I
I
21 7.1 28 52 95 359 99
22 5.3 26 49 93 267 91
23 6.7 24 43 98 341 93
, .
24 5.1 .
27 44 89 217 101
ACECWFENAC TABLETS lOOmg._KUSUM
45
.J
~ ,
-------
--
-
ITUVlQ
t: :
-, Jadavpur University, Kolmta - 700 032
0".0011
Tel :(033) 24146967 Fax: (033) 2414618616266
,APPENDIX NO. IDs
Sex-Male
INDIVIDUAL ANIMAL BLOOD CHEMISTRY
,-'"
. '_/
Group-Ill
Dose 5 mg/kg

,--,
Total
Blood
SOOT' SGPT SAP Animal Serum BUN
Sugar
(mifA,) (lUlL) (lUlL) (lUll) No. Protein
(tngOlo)
(g%)
26 51 99 349 94 5.7 25
28 48 90 26 6.4 91 265
43 381 97 27 5.8 33 94
- '"'-,
r----
28
r-
7.3 29 92 293 102 46
-------
1---'--'
6.9 27 41 102 371 98 29
5.2 25 54 219 30 97 93
APPENDIX NO.
"---"
Sex Female
Group III
Dose 5 mglkg

Animal
No.
Total
'Serum
Protein
(g%)
BUN
(miflo)
SGPT
(lUlL)
SOOT
(lUlL)
SAP
(lUlL)
Blood
Sugar
(mg%)
31
32
5.4
7.3
26
31
48
43
101
95
349
364
99
95
33 6.8 28 41 89 287 92
34 5.4 24 53 93 349 102
35
36
5.2
5.3
--------
26
25
----"
47
46
------
92
102
261
297
-1
97
94
ACECWFENAC TABLETS
46
r-'

/'."
l' ,

,- ,
"
-----
-----
'-- ./
Jadavpur University, Kolmta - 700032
Tel: (033) 24146967 Fax: (033) 2414618616266
APPENDIX NO. ill7
"
Sex-Male
Group-IV
Dose 10 mglkg
,----......
Animal
No.
Total
Serum
Protein
(g%)
BUN
(mgOlo)
SGPT
(lUlL)
SOOT'
(lUlL)
SAP
(lUlL)
Blood
Sugar
(mg%)
37 5.6 30 47 96 235 97
38 6.2 26 44 94 291 92
39 6.1 28 49
43
99 364 99
,....
40
_ .._ ..
41
5.8 27 97
-_.
379 101
._.
7.1 22
._.
52 93 384 89
42
._.
5.4 24 46 86 216 94
APPENDIX NO. ills
Sex Female
Group IV
Dose - 10 mglkg
._,----
Animal
No.
., 43
44
45
46
47
48
Total
Serum
Protein .
(g%)
5.4
6.1
5.8
6.3
7.3
5.5
BUN
(mgOlo)
._--- ...
27
24
26
23
22
28
SGPT
(lUlL )
54
48
43
47
41
46
SOOT
(lUlL)
95
92
102
99
87
98
SAP
(lUlL )
349
268
357
256
268
318
Blood
Sugar
(mg%)
93
._
97
100 .
98
.92
89
ACECLOFENAC TABLETS lOOmg__KUSUM
. 47
,
, : ~
Jadavpur University, Kolkata - 700 032 '
Tel: (033) 24146967 Fax: (033) 2414618616266
APPENDIX NO. WI
ORGAN WEIGHfS -ABSOLUTE VALVES (g)
, '
Sex- Male
Group-I
Dose - Control
Animal
No.
Body
Weight
(g)
Liver
(g)
Kidneys,
(g)
Heart
(g)
1 126.7 4.89 0.75 0.49
2
----
3
' 129.5
I--
129.7
5.46
5.37
---:--:C'
0.83
0.82
0.55
0.54
4 131.2 4.92 0.76 0.49
5 129.7 4.83 0.74 0.48
I
6 132.4 3.88 0.71 0.39
I
APPENDIX NO.IV2
Sex- Female
ORGAN WEIGHfS ABSOLUTE VALUES (g)
Group-J
Dose - Control
Animal
No.
Body
'Weight
(g)
Liver
(g)
Kidneys
(g)
------
Heart
(g)
7 128.2 5.34 0.82 0.53
8 125.1 4.28 0.72 0.43
------
9
------
129.1 5.39 0.83 0 ~ 5 4
10 126.4 4.37 0.74 0.44
11 131.7 5.41 0.83 0.54
12 127.4 4.29 0.73 0.43
ACECWFENAC TABLETS lOOmg._KUSllM'
48

IruvlQ)
.:: :.
OIlS'Ga
Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9001:2000 Cellified
APPENDIX NO. IV3
ORGAN WEIGHTS - ABSOLUTE VALUES (g)
Sex-Male
,-, Group-II

Dose - 2mglkg
Animal
No.
Body
Weight
,(g)
Liver
(g)
Kidneys
(g)
Heart
(g)
13 130.7 5.92 0.84 0.59
-----
14 127.3 4.67 0.73 0.47
15 131.7 4.39 0.72
---
0.81
0.44
...
0.52

16 127.8 5.21
17 129.7 4.63 0.72 0.46
18 125.9 4.99 0.74 0.50

APPENDIX NO. IV4
ORGAN WEIGHTS - ABSOLUTE VALUES (g)
Sex- Female
Group-II .
Dose - 2mglkg
Body
Liver Animal Kidneys Heart
Weight
(g) No. (g) (g)
(g)
19 5.37 125.9 0.83 0.54
20 129.2 4.68 0.73 0.47
21 127.5 5.19 0.82
---
0.52
22 130.7 5.42 0.84 0.54
r
I
23 132.7 0.72 4.38 0.44
I
24 5.18 128.4 0.81 -0.52
_/'
ACECLOFENAC TABLETS
49
"
('----'"
\
r- ,
----
;--\
',,- /)
Ir.w'l
4: ;
O1ISDtIJ
APPENDIX NO. IVs
Sex Male
ORGAN WEIGHTS - ABSOLUTE V ALlJES (g)
,-'
Group-Ill
lJose - ,:, mg/kg_
-- ,,:
I Animal
No.
Body
Weight
(g)
Liver
(g)
Kidneys
(g)
I
I
I
Heart
(g)
25 130.7 5.97 0.84
I
0.60
---
26 125:9 5.38 0.82
I
0.54
27 131.7
1--- -----
127.4
5.26
4.23
0.81
0.72
i
!
I
0.53
0.42
I
------
28
29 131.7 4.37 0.73
I
0.44
30 132.1 4.92 0.75
~
!
0.49
I
APPENDIX NO. IV6
ORGAN WEIGHTS ABSOLUTE VALUES (g)
Sex-Female
Group-ill
Dose 5 mglkg
Animal
No.
Body
. Weight
(g)
130.3
Liver
(g)
--
Kidneys
(g)
c--
0.75
0.72
Heart
(g)
0.49
0.44
31 4.92
32 127.4
-----
4.37
1-----
33 131.1 5.26 0.82 0.53
34 126.9 5.79 0.84 0.58
35 129.4 4.91 0.74 0.49
36 127.3 5.28 0.83 0.53
/ - ~ ,
ACECLOFENAC TABLETS IOOmgo_KUSmf
50
(----'\
r
"..
------
Jadavpur Univer.sity, Kolkata - 700 032
/"
Tel: (033) 24146967 Fax: (033) 2414618616266

APPENDIX NO. IV7
ORGAN WEIGIITS -ABSOLUTE VALUES (g)
Sex Male
Group IV
Dose - 10 mgll;:g
Animal
No.
31
38
39

40
41
42
Body
Weight
(g)
131.2
. 128.8
129.5
127.9
131.2
127.8
Liver
(g)
5.34
4.29
5.16
5.84
4.27
5.43
Kidneys
(g)
0.82
0.72
0.81
0.84
0.71
0.83
Heart
(g)
0.53
0.43
0.52
0.58
0.43
0.54
APPENDIX NO. IVg
ORGAN WEIGHfS- ABSOLUTE VALUES (g)
Sex- Female
Group-IV
(
Dose 10 mglkg
Animal Liver Kidneys Heart
No. (g) (g) (g)

43 127.4 5.34 0.82 0.53

44 130.7 4.61 0.73 0.46
45 '128.1 5.89 0.84 0.59
L __ 4.67 0.74 0.47
41 128.5 5.39 0.83 0.54
I
48 132.9 4.29 0.72 0.43 I
ACECLOFENAC TABLETS l00mg._KUSUM
51
--------
,-""
Jadavpur University, Kolkata - 700 032 '
Tel: (033) 24J46967 Fax: (033) 24146186/6266
/'
. APPENDIX NO. VI
ORGAN WEIGIITS - RELATIVE VALVES (%)
Sex Male
Group I
Dose - Control
Animal
No.
1
2 '- ."
3
4
5
6
Body
Weight
(g)
. 126.7
129.5
129.7
131.2
129.7
132.4
Liver
3.860
4.216
4.140
3.750
3.648
2.988
Kidneys'
0.592
0.641
0.632
0.579
0.559
0.547
Heart
0.39
0.42
0.42
0.37
0.36
0.30
i
APPENDIX NO. V
2
ORGAN WEIGHTS - REL-\TIVE VALVES (%)
Sex- Female
Group-I
\
",
Dose - Control
Animal
No.
Body
Weight
(g)
Liver
Kidneys Heart
7 4,17 0.64 0,41
8 125.1 3.42 0.58 0.34
9 129.1 4.18 0.64 0.42
10 126.4 3.46 0.59 0.35
11 131] 4.11 0.63 0.41
12 127.4 3.37 0.57 0.34
ACECLOFENAC TABLETS
52
r,
r',
------
------
'>...,-,,'
Department ofPharmaceutical Technology. .
.. .

a..:oat'"
Tel: (033) 24146967Fax: (033) 2414618616266 ISO SOO1:2OOO Certified
APPENDIX NO. V3
ORGAN WEIGIITS - RELATIVE VALUES (%)
Sex-Male
Group- II
Dose - 2mglkg
Animal
No.
13
'. r-
14
15
16
17
18
Body
Weight
(g)
130.7
127.3
. 131.7
127.8
129.7
125.9
Liver
4.53
3.67
3.33
4.08
3.57
3.96
Kidneys
0.64
0.57
0.55
0.63
0.56
0.59
Heart
..
0.45
0.37
0.33
0.41
0.35 I
0.40
I
APPENDIX NO. V
4
ORGAN WEIGIITS .c- RELATIVE VALUES (%)
Sex Female
Group II
Dose - 2mglkg
Animal
No.
Body
Weight
(g)
Liver
Kidneys Heart
19 125.9 4.27 0.66 0.43
20 129.2 3.62 0.57 0.36
21 127.5 4.07 0.64 0.41
22 130.7 4.15
-----
0.64 0.41
23 132.7 3.30 0.54 0.33
i
24 12&4 4.03 0.63 - 0.40
53

',-_/

I r r N ~
Jadavpur University, Kolmta - 700032 .
.; :
DlII 002
Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9001:2000Certified
APPENDIX NO. Vs
Sex-Male
ORGAN WEIGHfS RELATIVE VALVES (%)
Group III
Dose 5 mg/kg
Animal
No.
I--
25
Body
Weight
(g)
Liver Kidneys Heart
130.7 4.57 0.64 0.46
-
26
-
125.9 4.27 0.65 0.43_
27 131.7 3.99 0.62 0.40
28 127.4 3.32 0.57 0.33
29 131.7 3.32 0.55 0.33
30
-
132.1 3.72
-
0.57 0.37
APPENDIX NO. V6
Sex- Female
ORGAN WEIGHfS RELATIVE VALUES (%)
Group III
Dose - 5 mg/kg
~ -
Body
Animal
Liver Weight Kidneys Heart
No.
(g)
31 130.3 0.58 3.78
-
0.38
32 127.4 3.43 0.57 0.35
I
33 131.1 4.01 0.63 0.40
34 126.9 4.56 0.66 0.46
----f------
35 129.4 0.57 3.79 0.38
I-
36 127.3
4.15 0.65 0.42

c-. -
ACECLOFENAC TABLETS lOOmg._KUSVM
54
/
Department ofPharmaceutical Technology, .
Jaclavpur University, Kolkata - 700 032 .
APPENDIX NO. V
7
ORGAN WEIGHfS - RELATIVE VALUES (%)
Sex-Male
//" <"\
Group-IV
Dose - 10 mg/kg
Animal
No.
Body
Weight
(g)
Liver Kidneys Heart
37 131.2 4.07 0.63 0.40
38 128.8 3.33 0.56 0.33
39 129.5 3.98 0.63 0.40
~ . -
40 127.9 4.57 0.66 0.45
41 131.2 3.25 0.54 0.33
42 127.8 4.25 0.65 0.33
APPENDIX NO. Vg:
Sex Female
ORGAN WEIGHfS RELATIVE VALVES (%)
Group IV
Dose 10 mg/kg
r
Animal
No.
Body
Weight
-(g)
Liver Kidneys Heart
43 127.4 4.19 0.64 0.42
44 130.7 4.19 0.56 0.35
45 128.1 3.53 0.66 0.46
46
-_.
47
132.1 4.60 0.56 0.36
128.5 3.54 0.65 0.42
48 132.9 4.19 0.54 0.32
55
, ~
!'\
STUDY CENTRE
Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO Certified
APPENDIX NO. VII
INDIVIDUAL ANIMAL - GROSS AND HISTOPATHOLOGY FINDINGS
Sex: Male
Animal No. : 1-6
Group-I
Dose: 0 mg! Kg
Animal Fate: Terminal Sacrifice Days on Test: 28
Clinical Observations: NIL
Reference to necropsy record: NAD
Tissues with in the normal histological Limits: , Heart, Kidney,
Liver, Lung, Stomach .
Sex: Female
Animal No.: 7-12
Group I
Dose: 0 mg!Kg
Animal Fate: Tenninal Sacrifice Days on Test: 28
Clinical Observations : NIL
Tissues with in the normal histological Limits:
Heart, Kidney, Liver,
Lung,Stomach .
ACECWFENAC TABLETS l00mg._KUSllM
56

f'"

/------, Jadavpur University, Kolkata - 700 032 '
Tel: (033) 24146967 Fax: (033) 2414618616266
APPENDIX NO. VI2
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QMSOO1
INDIVIDUAL ANIMAL - GROSS AND mSTOPATHOLOGY FINDINGS
Sex: Male
'. --/
Animal No. : 37-42
Group IV
-' Animal Fate: Terminal Sacrifice
Clinical Observations: NIL '

Sex: Female
Animal No.: 43-48
Group-IV
Animal Fate : Tenninal Sacrifice
Clinical Observations : NIL
Reference to necropsy record: NAn
Dose: lOmg/ Kg
Days on Test: 28
, Heart , Kidney,
Dose: lOmg/ Kg
on Test: 28
Heart , Kidney,
ACECLOFENAC TABLETS lOOmg"_KUSlhlf
57
r-,

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