You are on page 1of 24

ll�T

Institute for Industrial Research & Toxicology


3ft�lr1cb � � fctll �$111 �
Registration No. 1303/C/CPCSEA (Ministry of Environment & 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

ACUTE DERMAL IRRITATION OF "ZERO MAX" TRANSFLUTHRIN


1.60% LIQUID VAPORIZER IN NEW ZEALAND WHITE RABBITS
(Guideline: OECD-404 acute dermal irritation)

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

INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY


F-209, UPSIDC, MG ROAD, GHAZIABAD-201302 (INDIA)
E-mail: info@toxicityindia.org
Website: www.toxicityindia.org
Tel No.: +91 9711623080
Fax: +91 11 22235111

STUDY NO : 202109-125
REPORT NO : IIRT/TOX/202109/ADl/0109
URLNo : TC661221000000109P
DATE : 27-10-2021


Page 1 of24

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
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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

Page 2 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

GLP COMPLIANCE STATEMENT

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

Mr. Ankur Rana 27-10-2021

Study Director Date

Page 3 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

STATEMENT BY TEST FACILITY MANAGEMENT

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

Test Facility Management Date

Page 4 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

QUALITY ASSURANCE STATEMENT

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.

Standard Test Method Compliance Audit 04-10-2021

Animal Preparation 05-10-2021

Test Material Preparation 06-10-2021

Application oftest compound 06-10-2021

Assessment of Response 06-10-2021 to 20-10-2021

Draft Repo1t Audit 24-10-2021

Signature Final Report Audit 27-10-2021

Ms. Shalini Mishra 27-10-2021

\.'�·-.·."-----::/
'\,
,

For Quality Assurance Unit Signature Date

Page 5 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

STUDY INFORMATION

PROJECT NUMBER 202109-125

REPORT NUMBER IIRT!TOX/202109/ ADVO 109

STUDY TITLE ACUTE DERMAL IRRITATION STUDY OF "MOS­


PLUCK" TRANSFLUTHRIN 1.60% LIQUID
VAPORIZER IN NEW ZEALAND WHITE RABBIT

HINDUSTAN AGRO
SPONSOR BY
Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)

MANUFACTURED BY HINDUSTAN AGRO


Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)

INSTITUTE FOR INDUSTRIAL RESEARCH &


TESTING LABORATORY TOXICOLOGY
F-209, UPSIDC, MG ROAD, GHAZIABAD-201302
(INDIA)
E-mail: info@toxicityindia.org
Website: www.toxicityindia.org
Tel No.: +91 9711623080
Fax: +91 11 22235111

Page 6 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

STUDY PERSONNEL

Study Director Mr. Ankur Rana, B.Phann

Study Personnel Mr. Mohssen, M.Pham1

Veterinarian Dr. Vandana Singh M.V.Sc.

Page 7 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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.

INITIAL TEST {USING ONE ANIMAL)

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.

The test substance "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER in


the amount of 0.5 ml was applied to a small area (approximately 6 cm2) of skin and covered
with a gauze patch, which was held in place with non-irritating tape. The first patch was applied
on the shaven back skin of rabbit and removed after a four hour exposure period. The response
was graded at 1, 24, 48 and 72 hour after patch removal. No skin reactions were observed at 1,
24, 48 and 72 hour observations after patch removal at treatment site. Finally, the animal was
observed for 14 days, for any irritation and co1Tosion.

CONFIRMATORY TEST {WITH ADDITIONAL ANIMALS):

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).

Page 8 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

The test compound "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


when applied to shaven back skin ofrabbits in the amount of0.5 ml produced no clinical sign of
edema and erythema after 24 hrs oftest compound application in intact as well as abraded skin
in female rabbits after 24 hrs ofapplication.

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
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

INTRODUCTION
OBJECTIVES

The study was conducted with the following objectives:

•!• To evaluate the dennal irritation potential of "ZERO MAX" TRANSFLUTHRIN


1.60% LIQUID VAPORIZER in New Zealand white rabbits.

•!• To find out "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


induced clinical signs in New Zealand white rabbits.

•!• 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.

Page 10 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

MATERIAL AND METHODS

TEST ARTICLE

Study title ACUTE DERMAL IRRITATION STUDY IN NEW


ZEALAND WHITE RABBITS
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 HINDUSTAN AGRO
Haridwar Road Mandawar
District Bijnor U.P. (246721) (INDIA)

•!• The sponsor shall be responsible for the test sample and its characterization.

TEST SYSTEM

1. Test Species New .Zealand white rabbit

2. Source Institute for Industrial Research & Toxicology

3. Age 10 to 12 weeks

4. Sex Female (Nulliparous)

5. Body weight range 1.60 kg± 200 gram

6. Identification By cage tag and con-esponding colour body marking

Page 11 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

7. No. of animals Three

8. Acclimatization The healthy rabbits selected for study was acclimatized to standard
laboratory condition for one week in experimental room under
Veterinary examination.

9. Randomization After acclimatization and Veterinary examination three males and


three females were randomly selected.

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.

Accommodation Animals were housed individually in stainless steel cages provided


with stainless steel mesh bottom and facilities for food and water
bottle.

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

Page 12 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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.

APPLICATION OF TEST COMPOUND

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.

Page 13 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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

Draize Dermal Irritation Scoring System

Erythema and Eschar Formation Value Edema Formation Value

No erythema 0 No edema 0

Very slight erythema (barely 1 Very slight edema (barely 1


perceptible) perceptible)

Well-defined erythema 2 Slight edema (edges of area 2


well defined by definite raising)

Moderate to severe erythema 3 Moderate edema (raised 3


approximately 1 mm)

Severe erythema (beet redness) 4 Severe edema (raised more 4


to slight, eschar formation (injuries than 1 mm and extending
in depth) beyond the area of exposure)

Page 14 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

Evaluation of dermal skin irritation index

The dem1al irritation index was evaluated at I, 24, 48 and 72 hrs intervals.

Irritation Index Evaluation

0.00 No irritation

0.01 -1.99 Slightly irritation

2.00-5.00 Moderate irritation

5.01- 8.00 Severe irritation

Source: From U.S. EPA (1988)

Page 15 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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.

Page 16 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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

The test compound "ZERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


applied on the shaven back skin ofrabbit at the dose level of0.5 ml did not produce any clinical
signs oftoxicity throughout the examination period of 14 days (Table- 4).

Page 17 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

TABLE-2

Individual Body Weight (kg)

Animal ID Sex DayO Day7 % Day 14 %


Gain/loss Gain/loss

Female 1.65 1.68 1.79 1.75 5.71


01

Female 1.63 1.66 1.81 1.74 6.32


02

Female 1.67 1.72 2.91 1.78 6.18


03

Page 18 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

TABLE-3

INDIVIDUAL ANIMAL SKIN IRRITATION SCORES

Animal no. Sex INTACT SKIN

1 Hours 24 Hours/1 day 48 Hours/2 day 72 Hours/3 day 14 days

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

Grand Total 0.00

Dermal Irritation Index: = 0.00


C==:J
c:::=::i

Page 19 of24
?3

w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

TABLE - 3 {Contd...)

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

Animal no. Sex ABRADED SKIN

1 Hours 24 Hours/1 day 48 Hours/2 day 72 Hours/3 day 14 days

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

Grand Total 0.00

Dermal Irritation Index: = 0.00

c:=::::J
c::::::::J

9

Page 20 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

TABLE-4

CLINICAL SIGNS

SEX ANIMAL No. Time (Hours) Time


(Day)
1 24 48 72 14

01 N N N N N
FEMALE
02 N N N N N

03 N N N N N

N: No Clinical Signs

Page 21 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

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
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

CERTIFICATE OF GLP

SA INTERNATIONAL
This is to certify that

l\;1/s Institute for Industrial Research & Toxicology


F-209. UPSIDC Phase-I. MG Road,. Ghaziabad (U_P_)-201010
113.:: been a=ssed and found to be c:onfonn!ng the re�iremenbt of the

GLP Facility

OE-CD Pl'inciples of Good Laboratory Practice

Pre-Clinical To:s:icology, Phannacology,


Analytical Chemi•m·y & l\ficro Biology
By QSA � UK

R.e;:i,;t rxtioD 1'umbM : QSA-D03:6


Initial Certifi..,.tion D"� : 30 J.I:arcb :01:
�C<>rtific<1tioa Dnte : !9 J\.lnrcb ?O!l
Certification :E:q,irl,· Du� : -ZS :!.brcb .:o:-t

QSA JN1!"ERNATICNAL
LIMITED
;J.7r Oki Citawccit.c:ir .S:-trcct
..
Lo._,, W<:1N:tAX. .ENGIAND

Email: inf<>€.-q.aLco.uk
We.b:\\'Ynt.qsai.ca.uk
Ra-1 ... 1•:.'l"i =<��o=Cc-:\'.:.:t!\-C: r�- Er��,,�=r-3 '1,S�-t !'r��h �..i-f!.t.::·,. 1 /lf-;t,,of' I :1:.1 ..
-'ti!:.-..::;-�•� 11� ;.,.- _---:.· I e;:,.:..t "" ,,,,.;," �1 .,',( - ; ,--._ ..-• 1,-N. :v-•.;;.• r:,1 R<. 1\1:. �n -�, f :::i-=.r.·.�! h"' ·:-i� .. :!.!.r:Y,ih:: ;:-,1;r•f !'i't ;.:!.,.._,-y,,. n:a •. t

Page 23 of24
w�f1rLi
nLi nLi l�
INSTITUTE FOR INDUSTRIAL RESEARCH & TOXICOLOGY, GHAZIABAD

TEST COMPOUND :Z " ERO MAX" TRANSFLUTHRIN 1.60% LIQUID VAPORIZER


SPONSORED BY : HINDUSTAN AGRO
STUDY : ACUTE DERMAL IRRITATION STUDY IN NEW ZEALAND WffiTE RAB"Bt™µ,,TS.,::==5
PROJECT NO. : 202109-125
REPORT NO. : IIRTffOX/202109/ADU0I09

CERTIFICATE OF ANALYSIS

Zobrlc India Privnte Limited


..:'\
;;;;;r...;._
l'-·' Survey Nn. IR2, IRJ/1, lR.1/2, r�nrhnl lld)'<l!: Nngnr,
ZOBELE Bhi111pore, Da111<111 -396210, lntlia
CUIOUt'
Tel: +'II 260 6622800 L-RI 16 ,R�v no
CERTIFICATE OF ANALYSIS
Pr(•Jucl : - IC-EI.F.H-DL1O-SET-GENE'-1S MOS-PLUCK UK

SAP ,L•Je : - 81107


Balch No/ MFG : - BNf1111<11 21
Qm1111ity : - JO.f:32 P�.
Date of Mfg : - 25-08-2021
Dale or Anulysis :- 25-08-2021
lnvui�e no & dot� :- <Jf•041)r1(J00495/06 09 .2011

Sr. No. TEST SPECIFICATIONS RESULTS

I OdOlll' ChJra,:t�i,tic uJuur ChurJdt:ri,1 ic odour

1 Appe-irance Cklr, Ml,,url.�s to very light yell,,w liquid Cbll' coiuurkss liquid

3 Den,ily ,'i]; 25"C (g/ml) 0.74 - 0.90 0.811

Tro.n�l1ulhdn W'ltenl f�bv.•/w)


4 0.836-0.968 0.894%
byGC

Status-
(/-------
Co,,,pll�d�· SP'=Cifo.Jl;f)n5
1)

r
�,0
"A

B
f.t..,

�< *
''-9\ �
�ii
o
(I)

0e, '�()
Anu!yscd by Appru.,d
by
Chcmi-t �
QA ManJg r
'

Page 24 of24

You might also like