FINAL REPORT

Study Title

SCREENING FOR THE EYE IRRITANCY POTENTIAL OF 

EXP1313100 USING THE BOVINE CORNEAL OPACITY AND 

PERMEABILITY TEST (BCOP TEST) 

Author

Test Facility

WIL Research Europe B.V.

Hambakenwetering 7

5231 DD ‘s-Hertogenbosch

The Netherlands

 

Laboratory Project Identification

Project 505701

Substance 205622/A

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EXP1313100 Project 505701 

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1. CONTENTS 

1. CONTENTS ...................................................................................................................................... 2

2. STATEMENT OF GLP COMPLIANCE ............................................................................................. 3

3. QUALITY ASSURANCE STATEMENT ............................................................................................ 4

4. SUMMARY ........................................................................................................................................ 5

5. INTRODUCTION .............................................................................................................................. 6

5.1. Preface ...................................................................................................................................... 6

5.2. Aim of the study ........................................................................................................................ 6

5.3. Guidelines ................................................................................................................................. 6

5.4. Storage and retention of records and materials ........................................................................ 7

6. MATERIALS AND METHODS .......................................................................................................... 7

6.1. Test Substance ......................................................................................................................... 7

6.1.1. Test substance information ............................................................................................. 7

6.1.2. Study specific test substance information ...................................................................... 7

6.1.3. Test substance preparation ............................................................................................ 7

6.2. Reference substances .............................................................................................................. 7

6.3. Test system ............................................................................................................................... 8

6.4. Study design ............................................................................................................................. 8

6.4.1. Preparation of corneas ................................................................................................... 8

6.5. Cornea selection and Opacity reading ...................................................................................... 8

6.6. Treatment of corneas and opacity measurements.................................................................... 8

6.7. Opacity measurement ............................................................................................................... 9

6.8. Application of sodium fluorescein ............................................................................................. 9

6.9. Permeability determinations ...................................................................................................... 9

6.10. Electronic data capture ........................................................................................................... 9

6.11. Interpretation .......................................................................................................................... 9

6.11.1. In vitro irritancy score ................................................................................................... 9

6.11.2. Acceptability of the assay ...........................................................................................10

6.12. List of deviations ...................................................................................................................10

6.12.1. List of protocol deviations ...........................................................................................10

6.12.2. List of standard operating procedures deviations ......................................................10

7. RESULTS .......................................................................................................................................10

8. DISCUSSION AND CONCLUSION ................................................................................................11

9. REFERENCES ...............................................................................................................................12

TABLES 

Table 1 Summary of opacity, permeability and in vitro scores ..................................................13

Table 2 Opacity score ................................................................................................................14

Table 3 Permeability score individual values (uncorrected) ......................................................14

Table 4 Permeability score individual values (corrected) ..........................................................15

Table 5 In Vitro irritancy score ...................................................................................................15

Table 6 Historical control data for the BCOP studies ................................................................16

APPENDICES 

APPENDIX 1 SUMMARY TABLE .......................................................................................................13

APPENDIX 2 INDIVIDUAL OPACITY, PERMEABILITY AND IN VITRO SCORES ...........................14

APPENDIX 3 HISTORICAL CONTROL DATA ...................................................................................16

APPENDIX 4 CERTIFICATE OF ANALYSIS ......................................................................................17

Final Report


EXP1313100 Project 505701 

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4. SUMMARY 

Screening for the eye irritancy potential of EXP1313100 using the Bovine Corneal Opacity and 

Permeability test (BCOP test). 

This report describes the ocular irritation properties of EXP1313100 on an isolated bovine cornea. The 

possible ocular irritancy of EXP1313100 was tested through topical application for 10 ± 1 minutes. 

The study procedures described in this report were based on the most recent OECD and EC 

guidelines. 

Batch E00873-025-001 of EXP1313100 was a brown solid. The test substance was added as it is via 

a gauze patch of approximately 2 cm2 directly on top of the cornea (approximately 400 mg). 

The negative control responses for opacity and permeability were less than the upper limits of the 

laboratory historical range indicating that the negative control did not induce irritancy on the corneas. 

The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 126 

and was within the historical positive control data range. It was therefore concluded that the test 

conditions were adequate and that the test system functioned properly. 

EXP1313100 induced ocular irritation through both endpoints in the category mild to moderate, 

resulting in a mean in vitro irritancy score of 4.3 after 10 minutes of treatment. 

Since EXP1313100 induced an IVIS > 3 ≤ 55.1, no prediction on the classification can be made. 

Final Report