I

Institute for Toxicological Studies

-------,

OECD GLP CERTIFIED By: National GLP Compliance Monitoring Aothority, Department of Saence & Technology, Government of India; The NetherlandsGLP Compliance Monitoring Program. Food and Conswner Product Safety Authority (VWA), The Netherlands.

REPORT
STUDY TITLE
Primary Skin Irritation Study

I
I
Testinsl Facility

of 'Inner lubricant layer material' of

permanently lubricated HDPE Duct (Yellow Coloured, 40133 mm)

in Rabbit

Sponsor

INTOX PVT. LTD.

375, Urawade, Tal. Mulshi, Dist. Pune - 41 1 042, Maharashtra, INDIA

MIS Veekay Plast,

E-109, Bagru Industrial Area (Extention), Phase-11, Jaipur, Rajasthan - 303 007
(Ref. : QA/TSEC/ND-I/EP/003/2010-1 1
Dated 09-04-2010)

Studv Number 11008

R e ~ o r tNumber R/11008/PS1/10

DATE : 11 June 2010

Total number of pages in this report : 11

INTOX PVT. LTD. 375, Urawade, Tal. Mulshi, Dist. Pune, Maharashtra, 411042, INDIA. Tel. +91-20-66548700 (30 Lines) Fax +91-20-66548799 E mail : intox@vsnl.com URL : www.intoxlab.com

Study Information
Study Number Report Number Study Title

Primary Skin Irritation Study of 'Inner lubricant layer material' of permanently lubricated HDPE Duct (Yellow Coloured, 40133 mm) in Rabbit

Sponsor

MISVeekay Plast,

E-109, Bagru Industrial Area (Extention), Phase- 1, Jaipur, Rajasthan - 303 007 1
(Ref. :QAITSECIND-I/EP/003/2010- 11

Dated 09-04-2010)
Testing Facility INTOX PVT. LTD. 375, Urawade, Tal. Mulshi, Dist. Pune - 411 042, Maharashtra, INDIA

Date of Submission of Final report :

11 June 2010

Study Director Date

Ms. P. R. ~ a c h ~ u t e

1 1 - 0 6 - 2010

Technical Director Date

Dr.

@3 . P. Pore

Approved for issue Director and CEO Management Date

fl
Page 2 of 11

CONTENTS
Page No.

SUMMARY

INTRODUCTION Objective Personnel

(3

MATERIALS AND METHODS Test Article Test System Husbandry Preparation of Test Animals and Treatment
6 6

7 7

OBSERVATIONS Skin Reactions

8

RESULTS Skin Reactions

9

CONCLUSION

TABLE Individual Animal Skin Irritation Scores

Page 3 of 11

W11008/PS1110

SUMMARY

'Inner lubricant layer material' of permanently lubricated HDPE Duct (40133 mm), was tested
for its skin irritation potential in New Zealand White rabbits as per the method of Draize, J. H.
(1965). The test article (0.5 gm) was applied to intact and abraded skin sites on the clipped back of

three rabbits per sex. The sites of application were covered with guaze patch secured with adhesive tape. The test article was kept in contact with the skin for 24 hours followed by removal of guaze patch and washing of the site of application. Skin reactions were evaluated at each site of

CJ'

application following Draize's method at 24 and 72 hours application. No skin reaction was observed in treated animals at abraded or intact sites. 'Inner lubricant layer

material' of permanently lubricated HDPE Duct (40133 mm), was found to be non-irritant to the
abraded and intact skin of rabbit. Primary Skin Irritation Index was found to be 0 (zero). The product i.e. 'Inner lubricant layer material' tested, did not show toxicity or dermatic hazards.

Page 4 of 11

W110081PS1110

INTRODUCTION

OBJECTIVE
The objective of primary skin irritation study was to evaluate the possible irritation potential of 'Inner lubricant layer material' of permanently lubricated HDPE Duct (40133 mm) when applied to the skin of rabbit.

PERSONNEL

Study Director

Mr. P. R. Pachpute M. sc.

Study Veterinarian

Dr. A. A. Kale M. v. sc.

Page 5 of 11

MATERIALS AND METHODS

TEST ARTICLE
The Sponsor is responsible for characterization of the test article. The following information was provided about the test article. Test Article Characteristics Sponsor
: 'Inner lubricant layer material' of Permanently lubricated HDPE Duct

: Yellow Coloured Duct (size 40133 mm)

: Mls Veekay Plast,

E-I 09, Bagru Industrial Area (Extention), Phase-ll, Jaipur, Rajasthan - 303 007
(Ref. : QAITSECIND-I/EPl003/2010-11

Dated 09-04-2010)

TEST SYSTEM
Test System Strain Source

: Rabbit : New Zealand White : Serum Institute of India Ltd., Pune (Vendor approved by Test Facility Management). : 7 to 8 months : 2.22 to 2.76 kg : By cage tag and marking on the ear

i-j ?-)
i

Age Body weight range Identification No. of animals

: Six (3 males and 3 females)

Page 6 of 11

Husbandry
Environmental conditions : Air conditioned rooms with 10- 15 air changes per hour, temperature between 17'-23' C, relative humidity 30-70% and illumination cycle set to 12 hours of artificial fluorescent light and 12 hours of darkness. Accomodation
: Animals were housed individually in stainless steel cages provided

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

: 'Nutrilab' brand extruded pelleted rabbit feed manufactured by ,MIS

Provimi Animal Nutrition India Ltd., Bangalore, was provided libitum. -

Water

: Potable water passed through online 'Aquaguard' water filter, was

provided ad libitum in glass bottles with stainless steel sipper tubes.

Preparation of Test Animals and Treatment

: Approximately 24 hours prior to the treatment fur from the dorsal

area of trunk of the animals was removed with electric clippers exposing an area admeasuring approximately 100 cm2. The test article (0.5 gm) was applied on intact and abraded skin sites. Care was taken so that the abrasions penetrated stratum corneum only and not the dermis. Each site of application was covered with a guaze patch which was secured in position with an adhesive tape. The treated animals were 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 article. After 24 hours the patches were removed and sites of application were washed with water.

Page 7 of 11

OBSERVATIONS
Skin Reactions :
The sites of application were observed for skin reaction if any. The intact and abraded sites of application on skin of each animal were observed for signs of erythema and oedema and the responses were scored following Draize's method at 24 and 72 hours after application.

Evaluation of skin reaction

Values Erythema and Eschar Formation

No erythema ............................................................................................ Very slight erythema (barely perceptible ) ............................................... Well - defined erythema .......................................................................... Moderate to severe erythema ................................................................. Severe erythema (beet redness) to slight eschar formation ( injuries in depth ) ..................................................................................................... Maximum possible - 4

Oedema Formation
No oedema

.............................................................................................

Very slight oedema ( barely perceptible ) ................................................ Slight Oedema ( edges of area well defined by definite raising ) ........... Moderate oedema (raised approximately 1 millimetre) ............................ Severe oedema (raised more than 1 millimetre and extending beyond area of exposure ) ................................................................................... Maximum possible - 4

2
3
4

Page 8 of 11

R111OO~IPSIII0

RESULTS

Skin Reactions Skin reactions at the intact and abraded sites of individual animals are presented in Table. No skin reaction was observed at abraded or intact site. Primary irritation score was found to be zero. The 'Inner lubricant layer material' of permanently lubricated HDPE Duct (40133 mm) did not cause irritation to skin in rabbit. The product i.e. 'Inner lubricant layer material' tested, did not show toxicity or dermatic hazards.

Page 9 of 11

CONCLUSION

'Inner lubricant layer material' of permanently lubricated HDPE Duct (40133 mm) when applied

to intact and abraded skin sites, did not cause irritation to skin in rabbit. Primary skin irritation score was found to be 0 (zero). The product i. e. 'Inner lubricant layer material' tested, did not show toxicity or dermatic hazards.

Page 10 of 11

TABLE

INDIVIDUAL ANIMAL SKlN IRRITATION SCORES

Animal No.

Sex

INTACT SKIN 24 hrs E Oe 0 0 0 0

0

ABRADED SKIN 24 hrs E 0

0
72 hrs

72 hrs

E
0 0

Oe 0 0

Oe 0 0 0 0 0 0 0 0

E
0

Oe
0

RE38481 RB8482 RB8483 R88484 RB8485 R88486 Total Mean

0 0 0 0 0 0 0
0

M M

0 0 0
0

0 0 0
0

0
0
0

0 0
0 0 0 0 0

0 0
0

F
F

0 0

0
0

0 0

0 0

0
0

Grand Total

E: Erythema
Primary skin irritation index:

Oe: Oedema

0/4=0

Page I 1 of 11