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Acute Eye Irritation - Rabbits
Acute Eye Irritation - Rabbits
SPONSORED BY
HINDUSTAN AGRO
Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)
MANUFACTURED BY
HINDUSTAN AGRO
Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)
TESTING LABORATORY
STUDY NO : 202109-125
REPORT NO : IIRT/TOX/202109/ADl/0109
URLNo : TC661221000000109P
DATE : 27-10-2021
•
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Corporate Office: A-27. Street No. 2 Madhu Vihar,( I.P. Extension), Delhi - 110092
Lab &. 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
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
CONTENTS
S.NO. PARTICULARS PAGE NO.
1. GLP COMPLIANCE STATEMENT 3
2. STATEMENT BY TEST FACILITY MANAGEMENT 4
3. QUALITY ASSURANCE STATEMENT 5
4. STUDY INFORMATION 6
5. STUDY PERSONNEL 7
6. SUMMARY 8-9
7. INTRODUCTION 10
Objective & Regulatory references 10
8. MATERIALS & METHODS 11-12
Test Article 11
Test System 11-12
Husbandry 12
9. EXPERIMENTAL PROCEDURE 13
Preparation of animals 13
Application of test compound 13
10. OBSERVATIONS 14-15
11. ARCHIVES 16
12. RESULTS 17
Body weight, Skin Reaction 17
Clinical Signs 17
Individual Animal body weight (T ABLE-2) 18
Individual Animal Irritation Score (TABLE-3) 19-20
Clinical Signs (TABLE-4) 21
13. CONCLUSION 22
14. GLP CERTIFICATE 23
15. CERTIFICATE OF ANALYSIS 24
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
The study "Acute dermal irritation in New Zealand white rabbits" with "ZERO MAX"
TRANSFLUTHRIN 1.60% LIQUID VAPORIZER was performed in accordance with the
standard 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.
This study was conducted in compliance with the principles of Good Laboratory Practices
(GLP) as published by OECD Guidelines for Testing of Chemicals No. 404 (Section 4:
Health Effects), "Acute Dermal Irritation/Corrosion" adopted on 28 July 2015.
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
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
Management of the test facility has made available all the resources to the Study Director
necessary for conduct of the present study in compliance with the principles of OLP.
I, the undersigned, take overall responsibility for the reliability of the work described in the
report with compliance of Good laboratory Practice.
27-10-2021
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
This Project No. 202109-125/ Report No. IIRT/TOX/202109/ADI/0109 entitled Acute Dennal
irritation Study of "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER in
New Zealand White rabbits was subjected to inspection 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 ofevaluation.
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
STUDY INFORMATION
HINDUSTAN AGRO
SPONSOR BY
Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)
Page 6 of24
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
STUDY PERSONNEL
Page 7 of24
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
SUMMARY
The Acute Dermal Irritation study of the test compound "ZERO MAX" TRANSFLUTHRIN
1.60% LIQUID VAPORIZER was conducted on New Zealand white rabbit at the Institute
for Industrial Re$earch & Toxicology. The study was conducted according to OECD
Guidelines for Testing of Chemicals No. 404 (Section 4: Health Effects),
"Acute Dermal Initation/Corrosion" adopted on 28 July 2015.
In the initial test, one healthy rabbit of body weight 1.60 kg ± 200 gram was selected for the
study after acclimatization. The hairs of back sides were removed (approximately 6 cnl) one
day earlier before the treatment. After that, the test compound 0.5 ml was applied at the
different sites on the shaven back skin of animal.
Because there was no corrosive effect observed in the initial test, a confirmatory test was done
in order to confirm the irritant or negative response of the test substance by using two additional
animals.
In the confirmatory test the test compound "ZERO MAX" TRANSFLUTHRIN 1.60%
LIQUID VAPORIZER "in the amount of 0.5 ml was applied on the shaven back skin of
two animals, each with one patch, for an exposure period of four hours. After four hours the
patch was removed and the skin reactions were graded according to Draize's method (Table 1).
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
The body weight of all the animals was observed weekly on day 0 (Before treatment), 7th and
14th (post treatment) and at the end of experiment it was found that there was significant
increase in body weight as compared to day 0.
Finally, results obtained from present investigation concluded that the "ZERO MAX"
TRANSFLUTHRIN 1.60% LIQUID VAPORIZER is non irritant to skin in New Zealand
White rabbit under the experimental conditions tested.
The irritation index was calculated for intact and abraded skin and was found 0.0 and 0.0
respectively.
Page 9 of24
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
INTRODUCTION
OBJECTIVES
•!• To calculate the dermal skin irritation index of test compound in New Zealand white
Rabbits.
REGULATORY REFERENCES
Test Guidelines
•!• The study was conducted in compliance with the modification OECD Guidelines for
Testing of Chemicals No. 404 (Section 4: Health Effects), "Acute Denna!
Irritation/Con-osion" adopted on 28 July 2015.
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
TEST ARTICLE
•!• The sponsor shall be responsible for the test sample and its characterization.
TEST SYSTEM
3. Age 10 to 12 weeks
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
8. Acclimatization The healthy rabbits selected for study was acclimatized to standard
laboratory condition for one week in experimental room under
Veterinary examination.
HUSBANDRY
Environmental Air conditioned rooms with 10-15 air changes per hour, temperature
conditions between 20 ± 3 °c, relative humidity 50-60% and illumination cycle
set to 12 hours artificial fluorescent light and 12 hours dark.
Diet Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh
Nagar, Delhi
Water Community tap water passed through 'Aqua Guard on line water
filter', was kept in glass bottles, ad libitum
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
EXPERIMENTAL PROCEDURE
PREPARATION OF ANIMALS
The animals were prepared 24 hrs prior to application of test product. The furs from the dorsal
area of trunk of animals were removed with electric clippers exposing an area measuring
approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion
penetrated the Stratum corneum only and not dermis.
The 0.5 ml of test compound was applied on a small area (- 6 cm2) of intact skin site. Each site
of application was covered with impervious dressing which was secured in position with
adhesive tape. The treated animals were then housed individually and plastic collar was put
around their necks in order to prevent access by the animal to the patch and resultant ingestion
of the test product. After patch removal, the dressing and unabsorbed test product was removed
and the site of application was cleaned with distilled water.
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
OBSERVATIONS
BODY WEIGHT:
The body weight of all the animals was observed weekly on day O (Before treatment), 7th and
14th (post treatment).
SKIN REACTION:
The site of application was observed for skin reaction if any. The intact skin site of application
of each animal was observed for signs of el)thema and edema and the responses were scored
following Draize's method at 1, 24, 48 and 72 hours after application.
CLINICAL SIGNS:
In addition to the observation of irritation, all local toxic effects, such as defatting of the skin,
and any systemic adverse effects were fully described and recorded.
TABLE-I
No erythema 0 No edema 0
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
The dem1al irritation index was evaluated at I, 24, 48 and 72 hrs intervals.
0.00 No irritation
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
ARCHIVES
The raw data and other material, sample of the test substance and the study report are being
retained for 09 years at Institute for Industrial Research and Toxicology, Ghaziabad on
completion of the study.
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
RESULTS
BODYWEIGHT
The body weight of all the animals recorded individually on day ih and 14th (post treatment)
showed nonnal gain as compared to day 0 (Table-2).
SKIN REACTION
The results obtained from present study reveal that "ZERO MAX" TRANSFLUTHRIN
1.60% LIQUID VAPORIZER when applied to shaven back skin of rabbits in the a.mount of
0.5 ml did not produced any sign of edema and erythema in intact as well as abraded skin in
female rabbits after 1, 24, 48 and 72 hrs of test compound application under the test condition.
These responses were graded according to Draize's Scoring method (Table- 3).
CLINICAL SIGNS
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
TABLE-2
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
TABLE-3
Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema
01 F 0 0 0 0 0 0 0 0 0 0
02 F 0 0 0 0 0 0 0 0 0 0
03 F 0 0 0 0 0 0 0 0 0 0
Total 0 0 0 0 0 0 0 0 0 0
Mean 0 0 0 0 0 0 0 0 0 0
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
TABLE - 3 {Contd...)
Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema
01 F 0 0 0 0 0 0 0 0 0 0
02 F 0 0 0 0 0 0 0 0 0 0
03 F 0 0 0 0 0 0 0 0 0 0
Total 0 0 0 0 0 0 0 0 0 0
Mean 0 0 0 0 0 0 0 0 0 0
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
TABLE-4
CLINICAL SIGNS
01 N N N N N
FEMALE
02 N N N N N
03 N N N N N
N: No Clinical Signs
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
CONCLUSION
Based on the results obtained from present investigation, it can be concluded that the test
compound "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER
when applied to shaven back skin of rabbits in the dose level of 0.5 ml did not produced any
sign of edema and erythema in intact as well as abraded skin in female rabbits under the
experimental conditions tested.
The irritation index was calculated for intact and abraded skin and was found 0.0 and 0.0
respectively.
The result obtained from present study concludes that the "ZERO MAX"
TRANSFLUTHRIN 1.60% LIQUID VAPORIZER is non irritant to skin in New Zealand
Page 22 of24
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
CERTIFICATE OF GLP
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INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD
CERTIFICATE OF ANALYSIS
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