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Test Method Evaluation Report

Cover of ICCVAM 2010 report on refinement methods for ocular safety testing

ICCVAM Test Method Evaluation Report: Recommendations for Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing

NIH Publication No. 10-7514

Please note: The complete report is a large document and may take a few moments to download. It may also not be accessible to readers using assistive technologies. Viewing the individual sections below may be faster and provide improved accessibility.

View Test Method Evaluation Report on a Proposed In Vitro Testing Strategy for EPA Classification and Labeling of Antimicrobial Cleaning Products

Complete Report

Main Body

  • Front Matter
    Includes Table of Contents, Lists of Tables and Figures, List of Abbreviations and Acronyms, Acknowledgements, Preface, and Executive Summary
  • Section 1: Introduction
  • Section 2: ICCVAM Recommendations for the Routine Use of Topical Anesthetics and Systemic Analgesics to Avoid or Minimize Pain and Distress in Ocular Safety Testing
  • Section 3: Validation Status: Routine Use of Topical Anesthetics and Systemic Analgesics in Ocular Safety Testing
  • Section 4: ICCVAM Recommendations for the Use of Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing
  • Section 5: Validation Status of the Use of Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing
  • Section 6: ICCVAM Consideration of Public and SACATM Comments
  • Section 7: References

Appendix A: ICCVAM Evaluation Timeline

Appendix B: ICCVAM-Recommended Test Protocol: Revised OECD Test Guideline 405 (Draize Test for Acute Eye Irritation/Corrosion) 

Appendix C: Background Review Document: Use of Topical Anesthetics, Systemic Analgesics, and Earlier Humane Endpoints to Minimize Pain and Distress in Ocular Toxicity Testing

  • Front matter: Includes Table of Contents, Acknowledgements, Preface, and Executive Summary
  • Main Body
    • Section 1: Background
    • Section 2: Clinical Identification of Ocular Pain in Animals
    • Section 3: Options for Pain Relief in Animals
    • Section 4: Biomarkers for Severe/Irreversible Ocular Effects as Earlier Humane Endpoints
    • Section 5: Summary
    • Section 6: References
    • Section 7: Glossary
  • Annex I: Minimizing Pain and Distress in Ocular Toxicity Testing: Summary of an ICCVAM/NICEATM/ECVAM Scientific Symposium
  • Annex II: Effect of Topical Anesthetic Pretreatment on In Vivo Ocular Irritation Hazard Classification
  • Annex III: Comparative Evaluation of Topical Anesthetics Proparacaine and Tetracaine

Appendix D: Independent Scientific Peer Review Panel Assessment

  • Appendix D1: Summary Minutes from the Peer Review Panel Meeting on May 19-21, 2009
  • Appendix D2: Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches

Appendix E: Federal Register Notices and Public Comments

  • Appendix E1: Federal Register Notices
    • 70 FR 13512 (March 21, 2005): Request for Data on Non-Animal Methods and Approaches for Determining Skin and Eye Irritation Potential of Antimicrobial Cleaning Product Formulations; Request for Nominations for an Independent Expert Panel
    • 72 FR 26396 (May 9, 2007): Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing
    • 72 FR 31582 (June 7, 2007): Request for Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies Using Standardized Testing Methods
    • 73 FR 18535 (April 4, 2008): Non-Animal Methods and Approach for Evaluating Eye Irritation Potential for Antimicrobial Cleaning Products (AMCPs): Request for Nominations for an Independent Expert Panel and Submission of Relevant Data
    • 74 FR 14556 (March 31, 2009): Announcement of an Independent Scientific Peer Review Panel on Alternative Ocular Safety Testing Methods; Availability of Draft Background Review Documents (BRD); Request for Comments
    • 74 FR 8974 (April 29, 2009): Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
    • 74 FR 33444 (July 13, 2009): Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches: Notice of Availability and Request for Public Comments
  • Appendix E2: Public Comments Received in Response to Federal Register Notices
  • Appendix E3: Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) Comments: SACATM Meeting on June 25-26, 2009
    View relevant excerpts from SACATM Minutes
    Full meeting minutes available on SACATM meeting page: refer to materials for 2009 meeting

Appendix F: Relevant U.S. Federal and International Ocular Toxicity Regulations, Labeling, and Test Guidelines

  • Appendix F1: Table of Relevant U.S. Federal and International Ocular Testing Regulations for Hazard Classification and Labeling
  • Appendix F2: U.S. Environmental Protection Agency Health Effects Test Guidelines: OPPTS 870.2400 - Acute Eye Irritation
  • Appendix F3: U.S. Environmental Protection Agency Office of Pesticide Programs Label Review Manual
    View on U.S. Environmental Protection Agency website
  • Appendix F4: Organisation for Economic Co-operation and Development Test Guideline 405: Acute Eye Irritation/Corrosion
    Please note: Appendix F4 is the version of OECD Test Guideline 405 that was adopted in April 2002. An updated Test Guideline 405 that reflects the recommendations made in this report was issued by OECD in October 2012.