## DRAFT REPORT

Study Title



## ACUTE EYE IRRITATION/CORROSION STUDY WIT H

EXP1313100

IN THE RABBIT

Author

Test Facility

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s

- Hertogenbosch

The Netherlands

Laboratory Pr oject Identification

Project 505702

Substance 205622/A

- Page 1 -EXP1313100 Project 505702

1. CONTENTS

1. CONTENTS

................................................................................................ ...................................... 2

2. STATEMENT OF GLP COM PLIANCE

............................................................................................. 3

3. QUALITY ASSURANCE ST ATEMENT

............................................................................................ 4

4. SUMMARY

................................................................................................ ....................................... 5

5. INTRODUCTION

.............................................................................................................................. 6

5.1. Preface

................................................................................................ ..................................... 6

5.2. Aims of the study

..................................................................................................................... 6

5.3. Guidelines

................................................................................................ ................................ 6

5.4. Storage and retention of records and materials

....................................................................... 7

6. MATERIALS AND METHOD S

.......................................................................................................... 8

6.1. Test substance

......................................................................................................................... 8

6.1.1. Test substance information

............................................................................................ 8

6.1.2. Study specific test substance information

...................................................................... 8

6.2. Test substance preparation

..................................................................................................... 8

6.3. Test system

.............................................................................................................................. 8

6.4. Animal husbandry

.................................................................................................................... 9

6.5. Weight of evidence analysis

.................................................................................................... 9

6.6. Study design

............................................................................................................................ 9

6.9. O bservations

.......................................................................................................................... 10

6.10. Electronic data capture

.......................................................................................................... 11

6.11. Interpretation

.......................................................................................................................... 11

6.12. List of deviations

.................................................................................................................... 11

6.12.1. List of protocol deviations

........................................................................................ 11

6.12.2. List of standard operating procedures deviati ons

.................................................... 11

7. RESULTS

................................................................................................ ....................................... 12

7.1. Irritation (Table 1 )

................................................................................................................... 12

7.2. Corrosion

................................................................................................ ................................ 12

7.3. Coloration / Remnants

........................................................................................................... 12

7.4. Toxicity / Mortality

.................................................................................................................. 12

APPENDICES

APPENDIX 1: TABLES

APPENDIX 2: TEST SUBSTANCE CERTIFICATE OF ANALY SIS

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2. STATEMENT OF GLP COM PLIANCE

WIL Research Europe B.V., 's

- Hertogenbosch, The Netherlands

The study described in this report has been correctly reported and was conducted in compliance

with:

T he Organi z ation for Economic Co

- operation and Development (OECD) Principles of Good

Laboratory Practice (GLP) (as revised in 1997) ENV/MC/CHEM (98) 17

.

The S ponsor is responsible for all test substance information unless determined by WIL

Research Europe B.V.

.

WIL Research Europe B.V.

.

Date: ................................................... Date: ............

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

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3. QUALITY ASSURANCE ST ATEMENT

WIL Research Europe B.V., ‘s

- Hertogenbosch, The Netherlands

This report was inspected by the WIL Research Europe Quality Assurance Unit to confirm that

the methods and results accurately and completely reflect the raw data.

During the on

- site process inspections procedures applicable to this type of study were

inspected.

The dates of Quality Assurance inspections are given below.

\

WIL Research Europe B.V.

Quality Assurance

Date: ............................

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4. SU MMARY

Acute eye irritation/corrosion study with EXP1313100 in the rabbit.

The study was carried out based on the guidelines described in:

OECD No.405 ( 2012 ) "Acute Eye Irritation / Corrosion"

EC

, No 440/2008

, B5 : "Acute T oxicity : Eye Irritation/Corrosion "

EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"

JMAFF Guidelines (2000), including the most recent revisions.

A single sample of 100 mg of the test material was instilled into an eye of one rabbit. After t he

lids were then gently held together for s everal second s to prevent loss of the test substance.

Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation resulted in irritation of the conjunctivae, which consisted of redness and discharge

, which completely resolved within 2 4 hours. However, t he test substance fell out of the eye

immediately after releasing the eyelids after instillation. Therefore, application of the test

substance was considered to have resulted in an insufficiently long exposure period to allow a

meaningfu l interpretation of the eye irritation hazard

. No further rabbits were therefore treated

and no formal interpretation of the study results was done.

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