2 - 14 Days

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BIOEQUIVALENCE STUDY CENTRE
Department of Pharmaceutical Technology, Jadavpur University, Kolkata .. 700 032

Tel: (033) 24146967 Fax: (O33) 24146186/6266, E-mail: tkpaL12@yahoo.com, Website: www.biostudyJn
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4 RATS
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LTD. SPONSOR:
2114, DELHI 110 001

CHIEF INVESTIGATOR: PAL
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In Collaboration with TAAB BIOSTUDY SERVICES, No.67/1B, IbrahimpurRoad, 3
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Floor, Flat No.6, Kolkata 700032.
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Approved by DCGI vide Letter No. 4-14/97-DC Pt (I) dt. 21
st
OCT 2002

ISO 9001:2000 Certified
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Department ofPharmaceutical Technology,
Jadavpur University, Kolkata - 700 032
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Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000 Cerlirred
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CONTENTS
4
PERSONNEL INVOLVED IN THE STUDY
STATEMENT OF COMPLIANCE
5
SUMMARY ANb CONCLUSION 6

IPPEFACE
7
IGeneral
.. f-. ----
7
I MATERIALS AND METHOD
Schedule
8
ACUTE ORAL TOXICITY STUDY LD 50 calculation 9
11\
AGJTE ORAL TOXICITY SpaDY:METHODS
11
Route ofAdministtation
Randomization, Numbering & Grouping ofAnimals
11
-11
Justification for Selection ofWister Stmin Rats for the Study
Route of Administtation and Reason for Choice 11
Dose Preparation 12
I I
12 OBSERVATIONS
.........._ ...
Symptoms 12
Mortality 12
12
Food Consumption

12
TERMlNAL STUDIES 13
RESULTS 14
Clinical Signs Mortality Body Weight 14
Food Consumption 15
Organ Weight 15
Necropsy 15
Histopathology 15
ACECLOFENAC lOOmg._KUSUM
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CONTENTS OF FIGURES, TABLES AND APPENDICES

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FIGURES
Group Mean Body Weight
Group Mean Food Consumption
TABLES
Allocation Of Animals To Various Groups
Summary Of Clinical Signs OfIntoxication
Mortality
Group Mean Body Weight
Group Mean Food Consumption
Group Mean Organ Weight
I Absolute Values (g)
I Relative Values (%)
Snnnua.ty Of Gross Pathology Finrlinm:
Of Histopathology Findings
APPENDICES (INDIVIDUAL ANIMAL, DATA)
Body Weight

Values (g)
Figures
1,11
III, Iv
Tables
A
B
C
U
E
H
I
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Appendix
11-4
IVI -IV"
Page No_
16,17
18,19
Page No
20
21
22
23
24
25
26
27
'HL,) 0

Page No
30-31
32-33
RelatIve Values (%) . 34-35 VI
V"
Gross And Histopa1hology Findings 36-37 VI] - VIz
ACECWFENAC TABLETS lOOmg__KUSUM
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. Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700 032
Tel: (033) 24146967 Fax: (033)24146186/6266, Email: tkpaL12@yahoo.com, Wabsite: www.biostudy.in .
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TaabBiostudySeNices, am.Floof,
Bioeqt,Jtvafence $tudyCentre
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.. Oepartment.ofPharmaceutical' TechnOlogy . '
. JadavpurUnlvarsiiy,KQlkEita ......100032 .
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The members ofthe Institutiooal ArrlmalBthicsComrrLittee(lAEC) ha'VescrutiijiZed
aspects of the protOcols' for carrying. out stUdy .
of thefollowing.dtug on tats and mice and .have app:fCtVed thesatI'leto
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at the TaabBiostudy ServiCes, 3
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FJOOr,Flat No.. 6,
Study.centre,Deparunent. ofPhatnlaceufi.ca1 ladavpm
University"KoIkata-1QO032
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Name :ofthe drug: III ACECLOFENAC TABLETS lOOmg
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Prof. (Dr.);f.K.Pal, ". _
Chamn." '. an InmtationalAnimllEtmcS:Committe
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Approved by DCGI vide Letter No. 4-14/97-DC Pt (I) dt. 21 III OCT 2002
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STATEMENT OF COMPLIANCE
.J
Project No.
Test Article
Project Tide
Bach no.
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TOXA (r) ACFT 0610
ACECLOFENAC TABLETS 100mg.
Acute Oral Toxicity Study (14 days)
K004fT/013
We hereby attest to the authenticity of the study and guarantee that the data is correct and
~ - . /
accurate to the best of our knowledge 81,d that the study was perfonned in accordance with
the procedure and the principles of Good Laboratory Practice for the testing of chemicals.
We hereby attest that this study was conducted in compliance with Protocol submitted to
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and approved by the sponsor.
The study also complies with the schedule Y of Drugs and Cosmetic Act (1940) and
regulations ofthe Committee for the Pillpose of Control and Supervision ofExperiments on
Animals.
Prof (Dr.) T. K. Pal
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ChiefInvestigator
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Dr, S. Agarwal
Quality Assurance Unit
Dr. T. K. Chattaraj, M.D.
CliniCal Pharmacologist
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Signature
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Signature
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01- 06 -l D
Date
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Date
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.
Date
ACECLOFENAC TABLETS 100mg._KUSUM
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'BIOEQUIVALENCE STUDY CENTRE
Department o/Pharmaceutical Technology,
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Tel: (033) 24146967 Fax: (033) 2414618616266
PERSONNEL INVOLVED IN THE STUDY
Chief Investigator Prof (Dr.) T. K. Pa1
Clinical Pharmacologist Dr. T. K. Chattaraj, M.D.
Prof (Dr.) S. G. Dastidar
Quality Assurance U oit
Dr. S. Agarwal
Investigating Team
Dr. AnjanDas, M. D.
Mr. AnirbandeepBose
Mr. Soumendra D & ~ a r
Mr. Nilendra Chatte:Ijee
Mr. Bikash Roy
Mr. Subhro Dutta
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Mr. Arun Ghorai
Mr. Sanjay Ghorai
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Mr. Ratan Gupta
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ACECLOFENAC TABLETS lOOmgo_KUSUM
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SUMMARY AND CONCLUSION
The present investigation deals with acute toxicity study of ACECLOFENAC
TABLETS lOOMG. on Wister Rats at the rate of 0 mgIKg, 100 mg/kg body weight
in accordance with the schedule Y ofdrugs and Cosmetic Act (1940).In case of acute
toxicity study oral LD50 found to be 100 mglkg The animals of both sex from
control groups shows normal body weight gain throughout 14 days periods but
administered dose groups do not exhibited normal body weight gain throughout 14
o
days after single administration ofdrug at the rate of 100 mglkg
o The quantity of food consumption by the animals was not found to be comparable
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There was some abnormality and lesion found from Histopathological Examination
of the organs viz. Heart, Kidneys, Liver, Lungs, Stomach.
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The supplied drug ACECWFENAC TABLETS lOOMG. did show some feature of
behavioral toxicity, hepatotoxicity and nephrotoxicity in the specimen at' its Id50
dose.
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Chief Investigator : Prof (Dr.) T. K Pal
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Clinical Pharmacologist : Dr. T. K. Chattaraj, MD
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In Charge of Quality Assurance Unit Dr. S. Agarwal
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ACECLOFENAC TABLETS lOOmg._KUSUM
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. Department ofPharmaceutical Technology,
Jadavpur Untversity, Kolkata - 700032 ~
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MATERIALS AND METHOD
TEST SYSTEM
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Species Rat
Strain Wister Strain Rats .
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Source Animal house, nCB, Kolkata
Sex: Male and female
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Age 6to 8 weeks
No. Ofanimals per'dose level 6 per sex per dose
Acclimation
Seven days prior to dosing
Identification ofanimals
By cage number and iridividual marking on fur
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Diet
Pelleted feed supplied by
"
MIs Ghosh Enterprise, Kolkata
Water
Aquaguard pure water in glass bottles
adlibitum
Housing
The rats were housed 6 each; of the 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.
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Dose
For Acute toxicity study Omg/kg, and
100 mg/kg
ACECLOFENAC TABLETS 100mgo_KUSUM
8
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Department 0/Pharmaceutical Technology,
Jadavpur University. Kolmta - 700 032 .
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Tel: (033) 24146967 Fox: (033) 2414618616266 ISO 9001:2000 CertifHld
ACUTE ORAL TOXICITY STUDY (LD 50 CALCULATION, LIMIT TEST
METHOD) PROCEDURE
~
Suspensions of ACECLOFENAC TABLETS lOOmg. at different doses were
prepared. A simple method for acute toxicity study is limit test method. 2000 mglkg
suspension was administered orally to six rats and observed for 24 hours.' All the
animals treated with.2000 mglkg body weight dose were died within 5 days. Then
we have started the up and down procedure in which several doses from minimum to
maximum dose levels of drugs were administered.
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Procedure:
'.
For up and down toxicity study sixty rats i.e., 30 male and 30 female healthy rats
were divided into five groups of 6 male and 6 female rats per sex i.e. five dose
groups receiving the dose of 100 mg/kg, 400 mglkg, 800mglkg, 1200mglkg and 1500
mglkg body weight The number of mortality found in each dose group animals was
shown below.
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Sex: Male
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Dose
Group No.
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(mg/kg)
I
I 100
I
II 400
-
, <ill
800
IV 1200
V 1500
Sex: Female
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Period of
Total
Animal Slgnsm
Mortality Number of <
Group No.
Dose
(mg/kg)
Total
Number of
Animals.
Animal
Nos.
Period of
SIgns In
days
from - to
Mortality
I
L100
6 7-12 1 -14
----
3/6
II 400 6 19-24
----
1-14
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1 -14
4 1 6 ~
ill
IV
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800
--
I
1200
6
--
31-36
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6 43-48
55-60
1 -14
-
V
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1500 6 1 -14
Animals.
6
6
6
6
6
days
from -to
Nos.
1 -14 3/6 1-6
13-18 1 -14 4/6
1 ...; 14 25-30 5/6
37-42 1 -14 616
49-54 6/6
,,
1 -14
---- - '------
Most of the animals died at dose level of 1500 mglkg, 1200 mglkg body weight.
< About 500/0 of animals of both the sexes died at the dose levels of 100mg/kg body
weight after 14 days of toxicity study, so we consider a dose of 100 mg/kg for carried .
out acute toxicity study on rats.
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Jadavpur University, Kolkala - 700 032
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METHODS
Randomization, Numbering and Grouping of Animals
For Acute toxicity study twenty four rats i.e. 12 male and 12female healthy rats were
divided into two groups of6 rats per sex i.e. four dose groups receiving the dose of0 mglkg,
and 100 mglkg body weight. Animals were allowed acclimation period of 7 days to
laboratory conditions prior to the initiation of dosing. 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 : Oral (gavages).
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Justification for selection ofWister Strain Rats for the Study
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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 industry for the evaluation oftoxicity ofvarious products,
4) Historical data and evidence at the facility ~
Route of Administration and Reason for Choice
OraL for 14 days. The oral route was selected for use because,
1) The dosage can be accurately administered,
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2) One ofthe proposed routes for toxicity testing,
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Oral route is considered to bea potential route ofhuman exposure.
DOSE PREPARATION
ACECLOFENAC TABLETS 100mg. was administered to rats at the dose levels of
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omglkg, lOOmglkg for acute toxicity in the dose volume of Im1l100g body weight. The
test article suspensions were freshly prepared everyday for 14 days. The control animals
were administered vehicle only.
11
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OBSERVATIONS
, Symptoms
All animals were observed daily for clinical signs. The time of onset, intensity and duration
ofthese symptoms, ifany, were recorded.
Mortality
All ariimals were observed twice daily for mortality during the period ofthe study.
Body weight
The weight of each rat was recorded on day 0 and at weekly intervals throughout the course
ofthe study. The groups mean body weights were calwlated.
Food consumption
The quantity of food consumed by groups consisting of six rats each was recorded weekly
and the food consumption per rat was calculated for control and dose groups.
TERMINAL STUDIES
Laboratory Investigations
Following laboratory investigations were carried out prior to sacrifice on completion of
dosing period of 14 days in animals' fasted over-night .
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ACECLOFENAC TABLETS l08mg._ KUSUM
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Necropsy

All animals were sacrificed on day 15, using cervical dislocation. Necropsy of all animals
was carried out and the weights of the following organs were recorded: Liver, kidneys and
heart. The organ weights were recorded as absolute values and their relative values (i.e. per
,j
cent ofthe body weight) were calculated.
Histopathology .
Following tissue samples of organs from control and animats treated at the highest dose
level of 100mglkg , were preserved in 100/0 formalin for histopathological examination.
Heart; Kidneys; Liver; Lungs; Stomach;
Heart, Kidneys, Liver, Lungs and Stomach of low and intermediate dose group animals were
preserved for possible histopathological examination, in case the histopathological
examination of high dose group animals is indicative of abnormalities associated with the
treatment.

ACECLOFENAC TABLETS lOOmg__KUSr1M

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RESULTS
Clinical signs (Table B)
Male-
Group I (0 mglkg) : AnL"'l1als were free of intoxicating signs throughout the dosing period of
14 days (animal nos. 1 to 6).
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Group II (100 mglkg ) : Animals have some intoxicating signs throughout the dosing period
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of 14days (animalnos. 13 to 18).
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Female-
Group I (0 mg/kg) : Animals were free of intoxicating signs throughout the dosing period of
14 days (animal nos. 7 to 12).
Group II (100 mg/kg) : Animals have some intoxicating signs throughout the dosing period
of 14 days (animal nos. 19 to 24).
Mortality (Table C)
Maleat"1d Female _ Mortality rate shown in Table No. C .
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ACECLOFENAC TABLETS lOOmg__KUSUM
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BODY WEIGHT (TABLE D; APP.I; FIG.I & ll)
Male-
Animals from control groups exhibited normal body weight but in case of high doses treated
animals, rate of weight gain decreases in comparison with the control group during the
dosing period of 14 days.
Female-
Animals from control groups exhibited nonnal body weight but in case ofhigh doses treated
animals, rate of weight gain decreases in comparison with the control group during the
dosing period of 14 days.
,-
ORGAN WEIGIITS(TABLE B & 1; APP. IV, V)
Male and Female
Organs ofanimals from control and the different dose groups exhibited normal weight.
NECROPSY (TABLE J; APP.VJ)
Summary of necropsy findings in male and female animals is described in Table J. The
gross pathological examination revealed no abnormality attributable to the treatment.
mSTOPATHOLOGY (TABLE K; APP.VJ)
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Summary of histopathological observations is given in Table no.K. The histopathological
observations on individual. animal given in App.VI.
,
Histopathological examination ofanimals from high dose group revealed some abnormality
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attril?utable to the treatment.
ACECLOFENAC TABLETS lOOIllg._KUSUM
15
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Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2Il00 Certified
ACUTE ORAL TOXICITY STUDY OF
ACECLOFENAC TABLETS lOOmg.
FIG NO. I: MALE (RA1) GROUPMEAN BODYWEIGHT
136
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134
-

0
1-1

132

0
=
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7
14
DAYS
j
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Department ofPharmaceutical Technology, .
Jadavpur University, Kolkata - 700032

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Tel: (033) 24146967 Fax: (033) 2414618616266 ISO 9001 :2D00 Certified

ACUTE ORAL TOXICITY STUDY OF.
ACECLOFENACTABLETS lOOmg.
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FIG NO.II: FErdALE (RAT) GROlJP l\IEAN BODY
WEIGHT (g)
136 --,--------------,,...-------

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134
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1-1

132
z

130

128
o 7
14
DAYS
-c?c- 0 mg I kg . -'>'l<- 100 mg I kg

ACECLOFENAC TABLETS 100mg__lWSllM
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_Department ofPh.armaceutical Technology.
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Jadavpur University. Kolkata - 700 032
Tel: (033) 24146967 Fax: (033) 24146186/6266
ISO 9001:2000 CedIfied
ACUTE ORAL TOXICITY STUDY OF
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FJG NO.m: MALE (RAJ) GROUP MEAN FOOD
-CONSUMPIlON (g/animal)
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ACUTE ORAL TOXICITY STUDY OF .
FIG NO.IV: FEMALE (RA1) GROUP MEAN FOOD
CONSUMPTION (gfanimal)
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ACUTE ORAL TOXICITY REPORT
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TABLE NO. A

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ALLOCATION OF ANIMALS TO VARIOUS GROUPS
No. ofAnimals in .
Animal Numbers
Dose (mglkg) Group No. Sex
eachgroup .
6 1-6
Male
I Control
6 7-12
-
Female
6 13-18
Male
II 100
19.:24 6
Female
ACECWFENAC TABLETS lOOmg._KUSUM
20

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Department ofPharmaceutical Technology. .
Jadavpur University, Kolkata - 700 032 11iiV'1
TABLE NO. B
EFFECT OF DRUG TREATMENT ON CLINICAL SIGNS OF INTOXICATION
~
Sex: Male
\,----/
Group No.
Dose
(mglkg)
Observed
Signs
Total
Number of
Animals.
Animal
Nos.
Period of
signs m
days
from - to
Mortality
I Control
------
NIL 6 1-6 1-14
1-14
0/6
------
3/6
.
IT
100
NIL 6 13-18
Sex: Female
Group No.
Dose
(mg/kg)
Observed
Signs
----
Total
Number of
Animals.
Animal
Nos.
Period of
Slgnsm
days
from-to
. Mortality
I Control NIL 6
7-12 1 - 14 0/6
IT
----
100
NIL 6 19-24 1-14 3/6
-------
ACECWFENAC TABLETS lOOmgo_KUSUM
21
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Jadavpur University, Kolkala - 700 032 .
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TABLE NO.C
MORTALITY
Under the conditions ofthe present study, the following mortality rates were recorded:
,..-.
Group
No.
Dose (mglkg)
Body weight
Male Female
Mor
Males
Relative
Absolute
%
tality.
Females
Relative
Absolute
%
.
I Control Control 0/6
0 0/6 0
IT
100 100 3/6 50 3/6 50
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ACECWFENAC TABLETS lOOmg__KUSUM
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TABLENO.D
GROUP MEAN BODY WEIGHT (g)
Sex- Male

IGr. No. : :: I .14
T , '
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J.YJ.,\;;all 1
-130.63 i31.05 132.28
Control
SD
6.79 6.20 6.52
Mean
'" .-/' 130.95 130.87 131.82
II
100
SD
7.33 4.57 5.46
r

Sex-Female
Gr. No.
Dose
mglkg
WEIGHT [gm)
0 7 14
I
Control
Mean
130.28 131.25 132.93

SD
3.48 3.53 3.08
II
100
Mean
134.04 134.33 135.20
<-------
SD
4.16 4.41 4.73
I
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ACECLOFENAC TABLETS
23


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TABLENO.E
GROUP MEAN FOOD CONSUMPTION (gI animal)
Sex-Male
Dose
Day
.
No.
0 14 7
mg/kg
i

I Mean Control
I
5.58
i
5.20 5.42
II Mean
100
5.89
I
5.44 5.62
Sex-Female

Dose
Day
Gr.Ko.
mg/kg
0 7 14
I Control Mean
5.00 5.24 5.62
II
"100
Mean
5.32 5.54 5.65
24

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Jadavpur University, Kolkala - 700 032 .
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Tel: (033) 24146967 Far: (033) 2414618616266
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TABLE NO. H
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GROUP MEAN - ABSOLUTE VALVES (g)
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Sex: Male
....
Body
Dose
Liver Kidneys Heart Weight Gr. No.
mglkg
(g)
0.76 0.46 Mean 4.63 132.28 I
Control
0.06 0.06 SD 0.66 6.79
0.48 0.79 Mean 4.89 132.15
100
II SD 0.05 0.04 0.55 7.26
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Sex: Female
Gr. No.
Dose
mglkg
Body
Weight
(g)
Liver Kidneys Heart
I
Control
Mean 132.93 4.87 0.78 0.48
SD 3.08 0.55 0.06 0.06
100
Mean 133.68 4.93 0.74 0.49
II SD 4.13 0.52 0.17 0.05
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Department 0/Pharmaceutical Technology, ~
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TABIENO. 1
GROUP MEAN RELATIVE VALUES (%)
Sex: Male
Gr.. No;
Dose
mglkg
Body
Weight
(g)
Liver
........
. Kidneys
, ...
Heart
I
Control
Mean
SD.
132.28
6.79
3.49
0.57
0.57
.
0.06
c
0.35
0.06
Mean 132.15 3.70 0.60
-----
0.03
0.36
0.02 II
_ ..
100
SD
-----
7.26 0.35
Sex' Female
-r .. _ .......
J ' ~ '
/-..."
"
Gr.No.
Dose
mg/kg
-----
Body
Weight
(g)
Liver Kidneys Heart
I
Control
Mean 132.93 3.67 0.59 0.36
SD 3.08 0.44 0.05 0.05
100
Mean 133.68 3.69 0.55 0.36
II SD 4.13 0.34
..... ....
0.12 0.04
...._.... . ... ~ .
26
'", --j
Jadavpur University. Kollwta - 700 032
/JiiV'l
Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9001:2000 Certified
TABLENO. J
SUMMARY OF GROSS PATIIOLOGY FINDINGS
/ ~ .
Sex: Male
/
1
Site and lesion observed
NAD
Group I
1..:6
IT
13-18
Sex: Female
\ . , ~ .../
~ -- --
Site and lesion observed Group I IT
NAD
I 7-12 I i ~ : I
NAD = No Abnormality Detected
27
,j
Jadavpur University. Kolmla - 700 032
rwt11J
Tel.' (033) 24146967 Fax: (033) 2414618616266 ISO 9001:2000Certified
TABLE NO. K
SlJl\.1MARY OF mSTOPATHOLOGY FINDINGS
Sex: Male
Fates: All "
,";;-",
Days: All
Group Omg/kg lOOmg/kg
Number of Animals 6 6
#SEV #SEV
Heart #Ex 5 5
Kidneys #Ex 5 5
/,
Liver #Ex 5 6
Lungs #Ex 5 5
Stomach #Ex 5 5
Severity calculated by the number oftissues examined
5= normal
6=rnildly abnormal
7= severely abnormal
28
''-.J'

Jadavpur University, Kolkata 700 032
......
Tel: (033) 24146967 Fax: (033) 2414618616266
ISO 9OIl1:2000 Certified
TABLE NO. K(CONTD.)

SUMMARY OF HISTOPATHOLOGY FINDINGS
Sex: Male
Fates: All
Days: All
-,'>-..--,
Group Omg/kg lOOmglkg
Number of Animals 6 6

--\
\
--_/
Heart #Ex
#SEV
5
#SEV
5
Kidneys #Ex 5 5
Liver #Ex 5 6
Lungs #Ex 5 5
Stomach #Ex 5 5
Severitv calculated by the number oftissues examined
5= normal
6=mildly abnormal
7= severely abnormal
ACECWFENAC TABLETS lOOmg._KUSUM
29

Tel: (033) 14146967 Fax: (033) 14146186/6166
"'"\
. ~
Sex: Male
Group: I
.",
Dose: Control
,
Sex: Female
Group: I
Dose: Control
,'"
\ ...........-/
1
,--,'
r-,
~ ,
)
"\
APPENDIX NO II
INDIVIDUAL Al\lJMAL - BODY WEIGHTS.(gm)
Animal No. 0 7 14
1 142.5 143.5 145.2
2 127.3 126.5 127.5
3 130.2 132.2 133.6
4 126.5 127.5 128.3
5 125.9 126.3 127.5
6 131.4 130.3 131.6
I
!
APPENDIX NO 12
lNTIIVIDUAL ANIMAL - BODY WEIGHTS (gm)
----
Animal No. 0 7 14
7 125.0 .126.3 128.4
8 128.5 129.3 131.2
9 130.2 132.6 133.5
i
10 132.6 133.5 134.5
11 130.2 129.6 132.5
12 ; 135.2 136.2 137.5
-----
ACECLOFENAC TABLETS 100mg._KUSlhV
30
~ - - - ~
~ ,
---
Jadavpur University. Kolkata -700 032
.: ;
~ 0".'02
"""
--='
APPENDIX NO 13
INDIVIDUAL ANIMAL - BODY WEIGHfS (gm)
Sex: Male
~
Group: II
~ Dose: 100 mg/kg
Animal No. 0 7 14
13 144.5
- -
14 125.6 - -
15 131.5 132.2 132.4
16 124.6 125.2 124.8
Jl7 129.5 130.2 - I
18 1352 136.2 135.4
I
-:-:--.
APPENDIX NO 14
-:>
INDIVIDUAL ANThfAL- BODY WEIGHfS (gm)
Sex: Female
Group: II
Dose 100 mglkg
--,.
Animal No .. 0 7 14
19 136.2 135.7
-
20 132.6 133.5 131.4
21 141.2 140.6 140.5
22 129.2 128.4
-
l
23 132.6 133.5 133.7
24 132.4 - -
":">
ACECLOFENAC TABLETS 100mgo_KUSUM
31
:':);,

BIOEQutvALENCE STUDY CENTRE
.
laS
-
Tel: (033) 24146967 Fax: (033) 2414618616266

. APPENDIX NO. NI
Sex-Male
ORGAN WEIGHTS ABSOLUfE VALUES (g)
Group I
Dose - Control
Animal
No.
Body
Weight
(g)
Liver
(g)
Kidneys
(g)
Heart
(g)
1 145.2 4.50 0.75 0.41
2 127.5 5.41 0.84 0.54
3 133.6 5.22 0.81 0.51
4 128.3 4.85 0.78 0.49
5 127.5 4.11 0.70 0.40
6 131.6 3.69 0.69 0.41
APPENDIX NO.N
2
ORGAN WEIGHTS ABSOLUTE VALUES (g)

Group-I
Dose - Control
....,
..."
Body
Animal Liver Kidneys Heart
Weight
No. (g) (g) (g}
(g)
7 128.4 5.10 0.81 0.51
8 131.2 5.20 0.84
0.54
9 133.5 4.27 0.72 0.41
10 134.5 4.09 0.70 0.40
----------
11
12
132.5
137.5
5.44
5.12
0.82
0.80
0.52
0.49
ACECWFENAC TABLETS lOOmgo_KUSUM
32
I?'""--<
?"'\
Jadavpur University, Kolkata - 700 032 .
JlN
5.1
"
\
\"' /
'\
Sex-Male
Group II
Tel: (033) 24146967 Fax: (033) 241461861 626i
APPENDIX NO. IV3
ORGAN WEIGHTS ABSOLUTE VALUES (g)
/
Dose -100 mg/kg
Animal I
Body
Liver Kidneys
H: -1
Weight
No.
(g)
(g) (g)
1'1 I .. AA I:
5.42
nOA
0.52 ~ J 1_.-.1 V.U'+
14 125.6 5.21 0.81 0.50
--
15 132.4 5.33 0.85 0.49
16 124.8 3.99 0.72 0.44
----
17 130.2 4.52 0.74 0.42
18 135.4 4.86 0.79 I 0.49
APPENDIX NO. IV4
ORGAN WEIGHTS - ABSOLUTE VALUES (g)
Sex-Female
Group-II
Dose --:-100 mg/kg
Animal
Body
No.
Weight
. (g)
19 135.7
20 131.4
21 140.5
--
22 128.4
23 133.7
24 132.4
Liver Kidneys Heart
(g) (g) (g)
4.42 0.75 0.45
5.32 0.84 0.54
---
5.61 0.87 0.55
4.25 0.41 0.41
----
4.88 0.76 0.47
5.10 0.80 I 0.50
ACECLOFENAC TABtETS lOOmgo_KUSUM
33
r-',
//'......"
\,
Department ofPharmaceutical Tec;hnology.
Jadavpur University, Kolkata - 7()() 032
Tel: (033) 24146967 Fax: (033) 2414618616266
APPENDIX NO. VJ
Sex Male
ORGAN WEIGHTS RELATIVE VALUES (%)
Group-I
/"
Dose - Control
/ ~ -
Animal
No.
Body
Weight
(g)
Liver Kidneys. Heart
1
2'
145.2
127.5
3.099
4.243
0.517
0.659
0.28
0.42
3 133.6 3.907 0.606 0.38
4 128.3 3.780 0.608 0.38
5 127.5 3.123 0.532 0.30
6
,---
131.6 2.789 0.522 0.31
-=
APPENDIX NO. V2
Sex-Female
ORGAN WEIGHTS RELATIVE VALVES (%)
Group-I
Dose - Control
Body
Animal
Weight I Liver l Kidneys I Heart
No.
(g)
7 128.4 3.97 0.63 0.40
8 131.2 0.64 3.96 0.41
9 133.5 3.20 0.E4 0.31
10 134.5 3.04 0.30 0.52
11 132.5 4.11 0.39 0.62
12 137.5 3.72 I 0.58 0.36
34
/'"-"',
,_/
Jadavpur University. Kolkata - 700 032 .
Tel: (033) 24146967 Fax: (033) 2414618616266
,-
APENDIXNO. V3
ORGAN WEIGHTS - RELATIvE VALUES (%)
,/ Sex Male
Group-II
Dose - 100 mg/kg
Animal
No.
13
'""-----"-,
14
Body
Weight
(g)
144.5
Liver
3.75
Kidneys
0.58
Heart
,-,
0.36
125.6 4.15 0.64 0.40
~ 5 132.4 4.03 0.64 0.37
16 124.8 3.20 0.58 0.35
I
17 130.2 3.47
3.59
0.57
0.58
0.32
----
0.36 18
,-,
135.4
_.
APPENDIX NO. V4
Sex-Female
ORGAN WEIGHTS RELATIVE VALUES (%)
Group IT
Dose -:- 100 mglkg
Animal
No.
19
r'
20
----
21
22
-' ,-,
23
24
. Body
Weight
(g)
135.7
131.4
140.5
128.4
133.7
132.4
Liver
3.26
,
4.05
3.99
3.31
3.65
.3.85
Kidneys
0.55
0.64
0.62
0.32
0.57
0.60
Heart
0.33
0.41
0.39
----
0.32
---
0.. 35
0.38
35
~ .
Department ofPharmaceutical TechnololSJ"
. _
: ;
....

Tel: (033) 24146967 Fax: (033) 2414618616266 ISO B001:2OCkI Certified
APPENDIX NO. VII
INDIVIDUAL ANIMAL - GROSS AND mSTOPATHOLOGY FINDINGS
(/--,
Sex: Male
Animal No. : 1-6
Group-I
Animal Fate: Terminal Sacrifice
Clinical Observations: Nll.
Reference to necropsy record: NAD
Dose: 0 mgt Kg
Days on Test: 14
Tissues with in the normal histological Limits: Heart, Kidney,
Liver, Lung, Stomach.
'<-
Sex: Female
/- "'.
Animal No.: 7-12
,f--"\
Group I
Dose :0 mgt Kg
Days on Test: 14
Clinical Observations: Na
'
Tissues with in the normal Limits:
Heart , Kidney,
Liver, Lung, Stomach.
36
'
. , - - ~ .
BIOEQUIVALENCE STUDY CENTRE '.J
Jadavpur University, Kolkata - 700032
Tel: (033) 24146967 Fax: (033) 24146186/6266 ISO 9001:2000 Certified
APPENDIX NO. VI2
INDIVIDUAL ANIMAL - GROSS AND mSTOPATHOLOGY FINDINGS
Sex: Male
Animal No. : 13-18
Group- IV
Dose: 100 mgI Kg
Animal Fate: Terminal Sacrifice Days on Test :14
Clinical Observations : Nll.
Tissues with in the normal histological Limits:
Heart, Lung, Stomach, kidney
Sex: Female
Animal No.: 19-24
Group IV
Dose: 100 mgI Kg
Days on Test: 14
Clinical Observations : Nll.
Tissues with in the normal histological Limits:
Heart, Kidney, Lung, stomach,
ACECWFENAC TABLETS 100mg__KUSUM
37
j
.......,
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