National Toxicology Program

National Toxicology Program
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Test Method Evaluation Report on In Vitro Ocular Test Methods


Ocular TMER CoverICCVAM Test Method Evaluation Report:
In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives

NIH Publication No. 07-4517

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Complete Report

Front Matter

Main Body

  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

Appendix A: 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

Appendix B: 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

Appendix C: 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

Appendix D: ICCVAM Recommended BCOP Test Method Protocol

Appendix E: ICCVAM Recommended ICE Test Method Protocol

Appendix F: ICCVAM Recommended IRE Test Method Protocol

Appendix G: ICCVAM Recommended HET-CAM Test Method Protocol

Appendix H: ICCVAM Recommended Reference Substances List

Appendix I: Federal Register Notices And Public Comments

  1. Federal Register Notices
  2. ICCVAM Consideration of Public Comments Received in Response to Federal Register Notices
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