## FINAL 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 Projec t Identification

Project 507908

Substance 205622/AEXP1313100 Project 507908

- Page 2 - 1. CONTENTS

REPORT

................................................................................................ ................................................... 1

ACUTE EYE IRRITATION /CORROSION STUDY WITH

......................................................................... 1

EXP1313100

................................................................................................ ............................................ 1

IN THE RABBIT

................................................................................................ ........................................ 1

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

6.1.3. Test substance preparation

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

6.2. Test system

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

6.3. Animal husbandry

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

6.4. Weight of evidence analysis

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

6.5. Study design

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

6.6. Preemptive pain management

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

6.7. Treatment

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

6.8. Observations

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

6.9. Electronic data capture

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

6.10. Interpretation

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

6.11. List of deviations

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

6.11.1. List of protocol deviations

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

6.11.2. List of standard operating procedures deviations

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

7. RESULTS

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

7.1. Irritation

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

7.2. Corrosio n

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

7.3. Coloration / Remnants

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

7.4. Toxicity / Mortality

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

8. CONCLUSION

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

APPENDICES

APPENDIX 1: TABLES

APPENDIX 2: TEST SUBSTANCE CERTIFICATE OF ANALY SISEXP1313100 Project 507908

- Page 5 - 4. SUMMARY

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.

Single samples of 0.1 mL of the test substance formulation were instilled into one eye of each of three

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

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness,

chemosis and discharge. The irritation had completely resolved within 24 hours in one animal and

within 48 hours in the other two animals.

Remnants of the test substance noted for all animals on the outside of the eyelids on Day 1.

Based on these results, the test substance does not have to be classified and has no obligatory

labelling requirement for eye irritation according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United

Nations (2011) (including all amendments) ;

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

(including all amendments).