National Toxicology Program

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Test Method Evaluation Report

Cover of the Anesthetics TMERICCVAM 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
Download complete report (364 pages, 5.9 MB)

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


View Test Method Evaluation Report by Section

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 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.
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