National Toxicology Program

Test Method Evaluation Report ICCVAM Test Method Evaluation Report: In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives NIH Publication No. 07-4517 Download complete report (13 MB, 484 pages) Please Note: Large files may take some time to download: times will vary based on the speed of the online connection. The complete report file may not be accessible to all readers; files of individual sections of the report linked below may provide improved accessibility. If you would like assistance in accessing this document, please send an email to the ICCVAM Webmaster [Send Email] or call NICEATM at 919-316-4729.

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Front matter sections:

Table of Contents

List of Tables

List of Abbreviations and Acronyms

ICCVAM Agency Representatives

Acknowledgements

Preface

Executive Summary

Main body sections:

1. Introduction


2. Bovine Corneal Opacity and Permeability (BCOP) Test Method
   1. BCOP Technical Summary
   2. ICCVAM Recommendations for the BCOP Test Method


3. Isolated Chicken Eye (ICE) Test Method
   1. ICE Technical Summary
   2. ICCVAM Recommendations for the ICE Test Method


4. Isolated Rabbit Eye (IRE) Test Method
   1. IRE Technical Summary
   2. ICCVAM Recommendations for the IRE Test Method


5. Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test Method
   1. HET-CAM Technical Summary
   2. ICCVAM Recommendations for the HET-CAM Test Method


6. Comparison of Performance Characteristics and General Recommendations for Four Evaluated In Vitro Test Methods


7. ICCVAM Recommendations on Substances for Validation of In Vitro Ocular Toxicity Test Methods for the Evaluation of Ocular Corrosives and Severe Irritants


8. References

Appendices:

1. Expert Panel Reports
   1. Expert Panel Report: Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
   2. Expert Panel Report: Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants - Addendum
   3. Summary Minutes from Expert Panel Meeting on January 11-12, 2005
   4. Summary Minutes from Expert Panel Teleconference on September 19, 2005


2. Comparison of Performance Characteristics of Four In Vitro Test Methods for the Identification of Severe Ocular Irritants or Corrosives
   1. Comparison of Performance Characteristics of Four In Vitro Test Methods for Identification of GHS Severe Ocular Irritants or Corrosives
   2. Comparison of Performance Characteristics of Four In Vitro Test Methods for Identification of EPA Severe Ocular Irritants or Corrosives
   3. Comparison of Performance Characteristics of Four In Vitro Test Methods for Identification of EU Severe Ocular Irritants or Corrosives


3. Relevant Federal Ocular Irritation Regulations and Testing Guidelines
   1. Table of Relevant Ocular Irritation Regulations
   2. 16CFR1500.42: Test for Eye Irritants
   3. 29CFR1910.1200: Hazard Communication
   4. EPA Health Effects Test Guidelines OPPTS 870.2400: Acute Eye Irritation


4. ICCVAM Recommended BCOP Test Method Protocol


5. ICCVAM Recommended ICE Test Method Protocol
   Please contact NICEATM to obtain this document


6. ICCVAM Recommended IRE Test Method Protocol


7. ICCVAM Recommended HET-CAM Test Method Protocol
   Please contact NICEATM to obtain this document


8. ICCVAM Recommended Reference Substances List


9. Federal Register Notices And Public Comments
   
   
   1. Federal Register Notices
      • 69 FR 13859 (March 24, 2004): Request for Public Comment on the Nomination for Ocular Toxicity Test Methods and Related Activities and Request for Data on Chemicals Evaluated by In Vitro or In Vivo Ocular Irritancy Test Methods
      • 69 FR 21565 (April 21, 2004): Request for Nominations of Scientific Experts for Independent Expert Panel Evaluations and/or other Reviews of In Vitro Testing Methods for Identifying Potential Ocular Irritants
      • 69 FR 64081 (November 3, 2004): Notice of an Expert Panel Meeting To Assess the Current Validation Status of In Vitro Testing Methods for Identifying Potential Ocular Irritants; Request for Comments
      • 69 FR 70268 (December 3, 2004): Notice of Additional Data and Analyses for the Assessment of the Current Validation Status of In Vitro Testing Methods for Identifying Potential Ocular Irritants
      • 70 FR 9661 (February 28, 2005): Second Request for Data on Chemicals Evaluated by In Vitro or In Vivo Ocular Irritancy Test Methods
      • 70 FR 13513 (March 21, 2005): Availability of Expert Panel Report on the Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
      • 70 FR 18037 (April 8, 2005): Ocular Toxicity Scientific Symposia: Mechanisms of Chemically-Induced Ocular Injury and Recovery and Minimizing Pain and Distress in Ocular Toxicity Testing
      • 70 FR 43149 (July 26, 2005): Availability of Revised Analyses and Proposed Reference Substances for In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
      • 70 FR 53676 (Sept. 9, 2005): Announcement of Expert Panel Meeting To Evaluate Revised Analyses and Proposed Reference Substances for In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
      • 70 FR 66451 (Nov. 2, 2005): Availability of a Second Expert Panel Report on the Evaluation of the Current Validation Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
   
   
   2. ICCVAM Consideration of Public Comments Received in Response to Federal Register Notices