Acute Dermal Irritation - Guinea Pig ZM

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Institute for Industrial Research & Toxicology

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Registration No. 1303 / C / CPCSEA (Ministry of Environment ft Forests, Government of India)
License No.: UP37370000001 (Food and Drug Administration, UP)
AN ISO 9001 : 2015, ISO 14001 : 2015, ISO 45001 : 2018 Certified Organization
GLP Certified, NABL (1S0/IEC 17025) Accredited
SKIN SENSITIZATION OF "ZERO MAX" "

TRANSFLUTHRIN 1.60% LIQUID VAPORIZER
IN GUINEA PIG
(OECD Guideline for testing of Chemicals No. 406)
SPONSORED BY
HINDUSTAN AGRO
Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)
MANUFACTURED BY
HINDUSTAN AGRO
TESTING LABORATORY
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY
F-209, UPSIDC, MG ROAD, GHAZIABADs

E-mail: info@toxicityindia.org
Website: www.toxicityindia.org
Tel No.: +91 9711623080
Fax: +91 11 22235111
Project No. 202109-125

Report No IIRT/TOX/202109/606/SST
URL No. TC661221000000606P
Date 23-10-2021
•
Corporate Office: A-27. Street No. 2 Madhu Vihar, ( I. P. Extension), Delhi - 110092
Lab 6: Works: F-209, UPSIDC, Phase-I, MG Road, Ghaziabad, Telefax: +91-11-22234111, 22235111, 9711623080/81/82/90
Email: iirtdelhi@gmail.com, info@toxicityindia.org, www.toxicityindia.org
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
TEST COMPOUND "ZERO MAX" " TRANSFLUTHRIN 1.60% LIQUID VAPORIZER
SPONSORED BY HINDUSTAN AGRO
STUDY SKIN SENSITIZATION IN GUINEA PIG
PROJECT No 202109-125
REPORT No. IIRT/TOX/202109/606/SST
CONTENTS
Sr.NO. PARTICULAR PAGE NO.
1. GLP COMPLIANCE STATEMENT 4

2. STATEMENT BY TEST FACILITY MANAGEMENT 5
3. QUALITY ASSURANCE STATEMENT 6
4. STUDY INFORMATION 7
5. STUDY PERSONNEL 8
6. SUMMARY 9
7. INTRODUCTION 10
8. OBJECTIVE 10
9. REGULATORYREFFRECES 10
10. MATERIAL 11-13
Test Articles 11
Test system 12
Husbandry 13
Preparation of Animals 13
Dose level and justification 13
11. METHOD 14-15
Pilot Study 14
Main Study 14-15
Challenge Exposure 15
Preparation of Animals 15
Reliability Check 15
Page 2 of 25

REPORT No. IIRT/TOX/202109i606/SST
12. OBSERVATION 16
13. RESULTS 17
Body weight 17
Clinical Sign 17
Skin Reaction 17
14. CONCLUSION, REFERENCES & ARCIDVE 18
15. Table-1: Individual Animals Body Weights 19
16. Table -2: Magnusson and Kligman Grading Scale For the 20
Evaluation of Challenge Patch Test Reactions
17. Table-3: Toxicity Signs 21-22
18. Table-4: Evaluations of Challenge Patch Test Reactions 23

(Treatment & Control Groups)
19. GLP CERTIFICATE 24
20. CERTIFICATE OF ANALYSIS 25
Page 3 of 25
TEST COMPOUND "ZERO MAX" " TRANSFLUTHRIN 1.60% LIQUID
SPONSORED BY VAPORIZER HINDUSTAN AGRO
GLP COMPLIANCE STATEMENT
The study "Skin Sensitization in Guinea Pigs" with "ZERO MAX" "
TRANSFLUTHRIN 1.60% LIQUID VAPORIZER was performed in accordance
with the standard operating procedures of Toxicology Department, Institute for
Industrial Research & Toxicology, as well as the approved study plan.
I hereby attest the authenticity of the study and guarantee that this report represents
a true and accurate record of results obtained and shall not be reproduced except in
full, without the written approval of the Sponsor.
The study was conducted to meet the requirements of the OECD Guideline for
testing of Chemicals No. 406, adopted 17 th July, 1992 and revised on 31st oct.
2020 in compliance with the principles of Good Laboratory Practices (G.L.P.).
All original raw data including documentation, the draft report, a copy of the final
report and the representative test item are archived in the archives at Toxicology
Department, Institute for Industrial Research & Toxicology. There were no known
circumstances that may have affected the quality or integrity of the study.
The sponsor is responsible for necessary evaluations of the test item concerning the
chemicals purity, identity, stability and other required data.
The chemical analysis of the test item "ZERO MAX" " TRANSFLUTHRIN 1.60%
LIQUID VAPORIZER was carried out by the sponsor.
Mr. Ankur Rana 23-10-2021
Study Director Date
Page 4 of 25
STATEMENT BY TEST FACILITY MANAGEMENT
Management of the test facility has made available all the resources to the Study
Director which was necessary for conduct of the present study in compliance
with the principles of GLP.
I, the undersigned, take overall responsibility for the reliability of the work
described in the report with compliance of Good laboratory Practice.
N.N. Mishra 23-10-2021
Laboratory In-charge Date
Page 5 of 25

QUALITY ASSURANCE STATEMENT
This Project No. 202109-125/ Report no. IIRT/TOX/202109/606/SST entitled "Skin

Sensitization of "ZERO MAX" " TRANSFLUTHRIN 1.60% LIQUID VAPORIZER
in Guinea Pig" (OECD Guideline for testing of Chemicals No. 406, Adopted 17th July,
1992 and revised on 31st oct. 2020) was subjected to inspections by the Quality Assurance
Unit.
This report has been audited by the Quality Assurance Unit, and is considered to be an
accurate account of the data generated and of the procedures followed. In each case, the
outcome of QA evaluation is reported to the Study Director and Management on the day
of evaluation. Audits of study documentation, and process inspections appropriate to the
type and as per scheduled of this study.
Standard Test Method Compliance 10-09-2021

Audit
Animal Preparation 11-09-2021
Test Material Preparation 12-09-2021
Application of test compound 12-09-2021
Assessment of Response 12-09-2021 to 13-10-2021
Draft Report Audit 18-10-2021
Signature Final Report Audit 23-10-2021
Ms. Shalini Mishra 23-10-2021
For Quality Assurance Unit Date
Page 6 of 25
7J
TEST COMPOUND "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER ·

"
SPONSORED BY HINDUSTAN AGRO � ��
PROJECT No 202109-12S
STUDY INFORMATION
PROJECT NUMBER 202109-125
REPORT NUMBER IIRT/TOX/202109/606/SST
STUDY TITLE SKIN SENSTIZATION OF "ZERO MAX"

TRANSFLUTHRIN 1.60% LIQUID VAPORIZER IN GUINEA
PIG
SPONSOR BY HINDUSTAN AGRO

HINDUSTAN AGRO
MANUFACTURED BY Haridwar Road Mandawar
INSTITUTE FOR INDUSTRIAL RESEARCH &

TESTING TOXICOLOGY
LABORATORY
F-209, UPSIDC, MG ROAD, GHAZIABAD-201302 (INDIA)
E-mail: info@toxicityindia.org
Website: WNW .toxicityindia.org

Tel No.: +91 9711623080/81/83
Fax: +91 11 22235111
Page 7 of 25
TEST COMPOUND "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER

REPORT No. IIRT/TOX/202109/606/ ST
STUDY PERSONNEL
Study Director Mr. Ankur Rana, B. Phann
Study Personnel Mr. Mohseen, M. Pharm
Veterinarian Dr. Vandana Singh, M.V.Sc.
Page 8 of 25
SUMMARY
A Guinea Pig Maximization Test (GPMT) of "ZERO MAX" TRANSFLUTHRIN

1.60% LIQUID VAPORIZER was conducted to evaluate the potential for dermal
contact sensitization. This study was conducted based on the requirements of OECD
Guideline for testing of Chemicals No. 406, Adopted 1ih July, 1992 and revised
on 31 st Oct. 2020. The Buehler test method was used in the study to evaluate the skin
sensitization potential of test product. Pilot study was performed on 3 animals (Guinea
Pig) with requisite dose level in occlusive test patch system on shaven flank skin of
guinea pig. The pilot study showed that even at the highest dose level of test chemical,
no dermal reaction was seen. Based on the observation we further moved for the main
study where the highest dose level of test chemical was selected for the induction
exposure as well as for the challenge exposure.
· The observed results after the challenge exposure showed that the test chemical did not
produce any significant sign of skin reaction at test dose level.
Base on the observation of current study it could be concluded that the test product is
non sensitizer to guinea pig skin.
Page 9 of 25
INTRODUCTION
Skin sensitization is an immunologically mediated cutaneous reaction to a substance. In the

assessment and evaluation of the toxic characteristics of the test substance, determination of
its potential to provoke skin sensitization reaction is important. Predictive animal tests to
determine the potential of substances to induce delayed hypersensitivity are most often
conducted in guinea pigs.
OBJECTIVES
To determine the Skin Sensitization potential of "ZERO MAX" TRANSFLUTHRIN 1.60%

LIQUID VAPORIZER in Guinea Pig as per OECD Guideline for testing of Chemicals (No.
406, Adopted 17th July, 1992)
REGULATORY REFERENCES
The study was conducted in compliance with the modification OECD Guidelines for
Testing of Chemicals (No. 406, Adopted 17th July, 1992) on conduct of Skin Sensitization.
Page 10 of 25
TEST COMPOUND "ZERO MAX" TRANSFLUTBRIN 1.60% LIQUID VAPORIZER
MATERIAL
TEST ARTICLE
STUDY TITLE SKIN SENSITIZATION IN GUINEA PIG
TEST COMPOUND "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID

VAPORIZER
BATCH NO. BN0080821
CHARACTERISTICS CLEAR, COLORLESS VERY LIGHT-YELLOW

LIQUID
MFG.DATE 25-08-2021
EXP.DATE NA
SPONSORED BY SOLACE ENTERPRJSES

18-1-510/117/AC/32, MOHAMMED COLONY PHASE
Ill, PHOOL BAGH CHANDRAYUNNGUTTA,
HYDERABAD, TELANGANA, 500005 (INDIA)
The sponsor shall be responsible for the test sample and its characterization
Page 11 of 25
TEST SYSTEM
1. Species Cavia Porcellus (Guinea Pigs)
2. Source Institute for Industrial Research & Toxicology
3. Sex Male
4. Body weight range 300-450 g
5. Identification By cage tag and con-esponding color body marking
6. Pilot Study
Total Number of Animals 3 (Three)
7. Main Study
Total Number of Animals 30 (Thirty)
Number of Groups Two [G 1- Treatment group (20)
G2- Control group (10)]
8. Route of Administration Topical application
9. Acclimatization The selected healthy Guinea Pigs were acclimatized

to standard laboratory condition under the
supervision of Veterinarian for period of one week.
10. Identification of Animals Animals were housed individually in appropriately

labeled cages.
11. Randomization Thirty animals were randomly distributed in two

groups test and control.
Page 12 of 25

Husbandry
1. Environmental The animals were kept in air conditioned rooms with 12-15
conditions air circulation cycle per hour., temperature between 22±3
0
c, relative humidity 50-60% and illumination cycle set to
12 hours artificial fluorescent light and 12 hours dark.
2. Accommodation Standard polypropylene cages were used to house the

animals. The cages were washed and used sterilized paddy
husk for individual animal cages.
3. Diet Pelleted feed supplied by Krishna Valley Agrotech LLP,

B7/8, first floor, double storey, Ramesh Nagar, New Delhi-
110015 (India) and carrot, cabbage for good supplemented.
4. Water Community tap water passed through 'Aqua Guard on line

water filter', was kept in glass bottles to ad-libitum.
Preparation of Animals
The hairs from the back of each animal were removed 24 hrs prior to application of test
compound. The precaution was taken during clipping of hairs; the epidennis of hairs
should not be damage.
Dose Levels and Justification
As per the regulatory requirement of OECD guideline
Page 13 of 25
METHODS
Buehler test method was adopted to evaluate the skin sensitization potential (Buehler, 1965).
Pilot Study
A pilot study was carried out on 3 guinea pigs to detennine the high dose that causes mild
skin irritation as well as the highest non-irritant dose.
To arrive at above doses, to the shaven flank of guinea pigs, the test item was applied at the
doses of0.lml, 0.2 ml, 0.5 ml (1:1 v/v mixture) in occlusive test patch system. The test item
was held in contact with the skin for 6 hr by an occlusive patch and bandage dressing.
Thereafter the bindings were removed and the animals were observed for dennal reactions.
It was observed that none of the animals administered with the above doses exhibited
dennal reaction.
On the basis of above observation, the high dose 0.5 ml was selected for induction
exposure and 0.2 ml was selected for challenge exposure.
The concentration of test substance used for each induction exposure was well tolerated
systemically and was the highest to cause mild to moderate skin irritation. However, the
concentration used for challenge exposure was the highest non-irritant dose.
Main Study
Induction Exposure
One flank of each of 30 acclimated animals was closely clipped of hair, without any
abrasion 24 hr before the induction exposure.
Treatment Group
A cotton pad about 4-6 cm2 in size was loaded with the test item at a dose of 0.5 ml. The
cotton pad was applied to the shaven area of animals oftreatment group and held in contact
with the skin by an occlusive patch and bandage dressing for a period of 6 hr. Animals
were observed every 2 hr to make sure that the test patch system was in placed.
Page 14 of 25

Control group
To the shaven flank of animals, distilled water was applied in cotton pad about 4-6 cm2 in
size. The cotton pad was held in contact with the skin by an occlusive patch and bandage
dressing for a period of 6 hr. Animals were observed every 2 hr to make sure that the test
patch system was in place. The same treatments were repeated in respective treatment
group and control group on days 7_and 15.
Challenge exposure
As in induction exposure, animals (both treatment and control groups) were closely clipped
of hair from the untreated flank, 24 hr before the topical application.
On day 28, to the closely clipped posterior flank of both treatment and control group, the
test item was applied in cotton pad at a dose of 0.2 ml. To the anterior flank area of both
the groups of animals, distilled water alone was applied in the pad. As in induction
exposure the cotton pad were held in contact with the skin for 6 hr by an occlusive patch
and bandage dressing.
Reliability Check
The sensitivity and reliability of the above method were validated as per OECD 406
Guideline. The experiment was carried out as detailed above using 10 male guinea pigs.
Mercaptobenzothiazole was used as the sensitizer. A concurrent control group (5 male) was
also maintained. It was concluded that the method employed was sensitive and reliable.
Page 15 of 25

OBSERVATIONS
Body weight:
Body weight of individual animal was recorded prior to the induction exposure and
at the end of the experimental period.
Clinical Signs:
Animals were observed for signs daily throughout the experimental period.
Grading of skin reactions:

The skin reactions were observed and scored at:
1. 30 hrs after application of the challenge patch
2. 54 hrs after application of the challenge patch.
The skin reactions were graded as per the Magnusson and Kligrnan Grading
Scale (Magnusson and Kingman, 1970) (vide Table- 1).
Page 16 of 25
RESULTS
Pilot study
Animals: 3 guinea pigs

Weight 300-450g
Dose 0.1 ml, 0.2ml, 0.5ml (I: I v/v mixture) in occlusive test patch system.
Duration of Exposure: 6 hr
Selection of Dose: High dose 0.5ml - induction exposure 0.2 ml - challenge exposure.
Main study
Body weight
Normal body weight gain was observed m the control and treatment group
animals on day 30 when compared to day.
Clinical Signs
Daily observation on animals did not reveal any sign. All animals were apparently
healthy throughout the experiment (Table-2).
Skin reaction
None of the animals of treatment group and control group presented any skin reaction at
30 and 54 hrs after application of the challenge patch. Since none of the animals of
treatment and control groups presented erythematous responses, a grade of '0' was given
to all the animals at both the time points of observation after the challenge patch
application (Table-3).
Page 17 of 25
REFERENCES
1. Buehler, E.V. Delayed contact hypersensitivity m the gumea pig. Arch.

Dermatol., 91, 171, 1965.
2. Magnusson, B. and Kligman, A.M. Allergic Contact Dermatitis in the Guinea

Pig. Charles G. Thomas, Springfed, Illinois, 1970.
3. OECD, Organisation for Economic Co-operation and Development. OECD

guidelines for testing o( chemicals. OECD, Paris, 1998.
ARCHIVE
Study plan, raw data, documentation and a copy of the final report are retained in
the Institute's Archives at Institute for Industrial Research & Toxicology, F-209,
UPSIDC, M.G Road, Ghaziabad, India for a period of09 years.
CONCLUSION
On the basis of the findings of the present study and according to the Magnusson and
Kligman Grading Scale, none of the animals showed any skin reactions after
the challenge application, hence the test substance "ZERO
MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER is classified not a
sensitizer to the skin ofguinea pigs under the experimental conditions.
Page 18 of 25

TABLE-1
Individual Animals Body Weights
Body Body
Group Animal ID Animal ID
Weight (Grams) Weight (Grams)
202109-125-01 328 202109-125-11 336

202109-125-02 202109-125-12
340 325
202109-125-03 202109-125-13
324 339
202109-125-04 202109-125-14
325 348
202109-125-05 202109-125-15
345 345
Test
202109-125-06 202109-125-16
330 351
202109-125-07 202109-125-17
320 344
202109-125-08 202109-125-18 337
330
202109-125-09 202109-125-19
334 326
202109-125-10 202109-125-20
347 374
202109-125-01 202109-125-06
339 340
202109-125-02 202109-125-07
333 342
202109-125-03 202109-125-08
Control 327 330
202109-125-04 202109-125-09
325 342
202109-125-05 202109-125-10
338 337
Page 19 of25
TEST COMPOUND "ZERO MAX" TRANSFLUTHRJN 1.60% LIQUID VAPORIZER

TABLE-2
Magnusson and Kligman Grading Scale for the Evaluation of Challenge Patch Test
Reactions
Observation Grade
No visible change 0
Discrete or patchy erythema 1
Moderate and confluent erythema 2
Intense erythema and swelling 3
Page 20 of 25
REPORT No. lIRT/TOX/202109/606/SST
TABLE-3
Toxicity Signs
Treatment Group
Animal
No.
0 1 2 3 4 5 6 7 8 9 10 11 12 13 15 15 17 18 19 20 21 22 23 24 25
16 26 27 28 29 30
1 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N
12 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N .N
13 N N N N N N N N N N N N N N N N N N N N
N N N N N N N N N N N
16 N N N N N N N N N N N N N N N N N N N N
N N N N N N N N N N N
17 N N N N N N N N N N N N N N N N N N N N N N N
N N N N N N N N
19 N N N N N N N N N N N N N N N N N N N N N N N
N N N N N N N N
N- No Signs Contd.....
c===i
c===i
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Page 21 of 25 c:::{]

STUDY SKIN SENSITIZATION lN GUINEA PIG
REPORT No. DRTrfOX/202109/606/SST
TABLE- 3 (Contd....
Toxicity Signs
Control Group
Animal
No.
0 1 2 3 4 5 6 7 8 9 10 11 12 13 15 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
N-No Signs
1c::===i
5J
r::::=::::::J
Page 22 of 25

TABLE-4
Evaluations of Challenge Patch Test Reactions*
Treatment Group
(After application of the Challenge patch)
Hours Animal No.
1 2 3 4 5 6 7 8 9 10 11 12 13 15 15 16 17 18 19 20
30 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
54 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
*- vide Table-1
Control Group
Hours Animal No.

21 22 23 24 25 26 27 28 29 30
30 0 0 0 0 0 0 0 0 0 0
54 0 0 0 0 0 0 0 0 0 0
*- vide Table-I
c::=:=.J
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Page 23 of 25
GLP CERTIFICATE
INTERNATIONAL
This is to certify that
1\11/s Institute for Industrial Research & Toxicology

F-209, UPSIDC Phase-L MG Road, Ghaziabad (UP.)-201010
hos been a!fressed a:,d found to be ccnformng the requirement� of the
GLP Facility
OECD Pt·inciples of Good Laboratory Practice
for the scope of
Pre-Clinical Toxicology, Phai-macolog)',

Analytical Chemistry & Micro Biology
ByQSA�l,OK
fup_<tranonNumbu : QSA-ll03::6
Initial Certifieation D.ote : 30 Abrch ':!OU
�Certificaffllll Date : !9 !.>farcli ZO:!l
Ce.rti:ficnti1111 :fu:piry D:ate : :!8 March :!0:!4
QSA INTERNkTIONAL
LIMITED
27, QIO «;to�t-• �treer..
u::-._ WC1NlAJ{..E.NGlA'-D
Email: info;!tqsai.co.uk
Web:www.qsai.oo.uk
A11;_;�"&r«:t:al¾ �:;.��·dC: ui::: r::r&;;:.;:di:d"l,�� l'r,;i,.S,ih �. �!-J'.:--,''-' two:ri' :l�i1.:.
7·it �1·.r .� y H' ;.r -·:. 1J r�"';t..1
1 ..:,.• 1...:..-: I •�rM11,·r,. :-.-,.�: r,·,1 :r. t1t:�: :"\.:r>.,._::�· ::."l:.:-1·,:1 ti�r:.�:;r..;j•..:r.ntr.�r:;)C;u-:t u� i.::.::.i·.x -;n;;�.:1.
Page 24 of 25

CERTIFICATE OF ANALYSIS
Hindustan Agro
Haridwar Road Mandawar, District Bijnof U,P, India (246721)
Tel: +91 260 6622800
L-Rl16, Rev.00
CERTIFICATE OF ANALYSIS
Product : IC-ELEH-DUO-SET-GENESIS ZERO MAX UK .
SAP Code : 81107

Batch No/ MFG : BN0080821
Quantity : 19.632 Pcs
Date of Mfg : 25-08-2021
Dute or Analysis : 25-08-2021
Invoice no & date : 000400000495/06.09.2021
Sr. No. TEST SPECIFICATIONS RESULTS
I OJ�iur Characteristic odour Characteristic odour
2 Appearance Clear, colourless to very light yellow liquid Clear colourless liquid
3 Density @ 25°C (g/ml) 0.74 - 0.90 0.811
Transfluthrin content (%w/w)

4 1.536%-1.66% 1.61%
by GC
Status -
,._,,,...---
Complies/doesn't comply specification
��ii
0B
-J
'\�0
. U.l
? *
o»,v-.N r
<Y
I •
Approved by
Anulysed by : �
QA Manager o)'
Chemist
Page 25 of 25

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ll�T

Institute for Industrial Research & Toxicology

SKIN SENSITIZATION OF "ZERO MAX" "

F-209, UPSIDC, MG ROAD, GHAZIABADs

Project No. 202109-125

Sr.NO. PARTICULAR PAGE NO.

1. GLP COMPLIANCE STATEMENT 4

3. QUALITY ASSURANCE STATEMENT 6

10. MATERIAL 11-13

Dose level and justification 13

11. METHOD 14-15

TEST COMPOUND "ZERO MAX" " TRANSFLUTHRIN 1.60% LIQUID VAPORIZER

14. CONCLUSION, REFERENCES & ARCIDVE 18

15. Table-1: Individual Animals Body Weights 19

17. Table-3: Toxicity Signs 21-22

18. Table-4: Evaluations of Challenge Patch Test Reactions 23

19. GLP CERTIFICATE 24

20. CERTIFICATE OF ANALYSIS 25

GLP COMPLIANCE STATEMENT

Mr. Ankur Rana 23-10-2021

Study Director Date

STATEMENT BY TEST FACILITY MANAGEMENT

N.N. Mishra 23-10-2021

Laboratory In-charge Date

TEST COMPOUND "ZERO MAX" " TRANSFLUTHRIN 1.60% LIQUID

QUALITY ASSURANCE STATEMENT

This Project No. 202109-125/ Report no. IIRT/TOX/202109/606/SST entitled "Skin

Standard Test Method Compliance 10-09-2021

Animal Preparation 11-09-2021

Test Material Preparation 12-09-2021

Application of test compound 12-09-2021

Assessment of Response 12-09-2021 to 13-10-2021

Draft Report Audit 18-10-2021

Signature Final Report Audit 23-10-2021

Ms. Shalini Mishra 23-10-2021

For Quality Assurance Unit Date

TEST COMPOUND "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER ·

PROJECT NUMBER 202109-125

REPORT NUMBER IIRT/TOX/202109/606/SST

STUDY TITLE SKIN SENSTIZATION OF "ZERO MAX"

SPONSOR BY HINDUSTAN AGRO

INSTITUTE FOR INDUSTRIAL RESEARCH &

Website: WNW .toxicityindia.org

TEST COMPOUND "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER

Study Director Mr. Ankur Rana, B. Phann

Study Personnel Mr. Mohseen, M. Pharm

Veterinarian Dr. Vandana Singh, M.V.Sc.

A Guinea Pig Maximization Test (GPMT) of "ZERO MAX" TRANSFLUTHRIN

Skin sensitization is an immunologically mediated cutaneous reaction to a substance. In the

To determine the Skin Sensitization potential of "ZERO MAX" TRANSFLUTHRIN 1.60%

STUDY TITLE SKIN SENSITIZATION IN GUINEA PIG

TEST COMPOUND "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID

BATCH NO. BN0080821

CHARACTERISTICS CLEAR, COLORLESS VERY LIGHT-YELLOW

SPONSORED BY SOLACE ENTERPRJSES

1. Species Cavia Porcellus (Guinea Pigs)

2. Source Institute for Industrial Research & Toxicology

4. Body weight range 300-450 g

5. Identification By cage tag and con-esponding color body marking

8. Route of Administration Topical application

9. Acclimatization The selected healthy Guinea Pigs were acclimatized

10. Identification of Animals Animals were housed individually in appropriately

11. Randomization Thirty animals were randomly distributed in two