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In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants
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Test Method Evaluation Report

November 2006

View entire report in PDF format (13 MB)

Table of Contents

Table of Contents
List of Tables
List of Abbreviations and Acronyms
ICCVAM Agency Representatives
Acknowledgements
Preface
Executive Summary

 Ocular TMER Cover
I.   Introduction

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

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

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

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

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

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

VIII.  References

APPENDICES

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
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
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. Health Effects Test Guidelines OPPTS 870.2400: Acute Eye Irritation
D:  ICCVAM Recommended BCOP Test Method Protocol

E:  ICCVAM Recommended ICE Test Method Protocol

F:  ICCVAM Recommended IRE Test Method Protocol

G:  ICCVAM Recommended HET-CAM Test Method Protocol

H:  ICCVAM Recommended Reference Substances List

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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