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Test Method Evaluation Report: Low Volume Eye Test

ICCVAM Test Method Evaluation Report: Recommendation to Discontinue Use of the Low Volume Eye Test for Ocular Safety Testing

NIH Publication No. 10-7515

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.

Complete Report

Front Matter

Includes Table of Contents, Lists of Tables and Figures, List of Abbreviations and Acronyms, Acknowledgements, Preface, and Executive Summary

Main Body

  • Section 1: Introduction
  • Section 2: ICCVAM Recommendations for the LVET Test Method
  • Section 3: Validation Status of the LVET Test Method
  • Section 4: ICCVAM Consideration of Public and SACATM Comments
  • Section 5: References

Appendix A: ICCVAM Evaluation Timeline

Appendix B: ICCVAM Summary Review Document: The Low Volume Eye Test

  • Front matter: Includes Table of Contents, Acknowledgements, Preface, and Executive Summary
  • Section 1: Background on Ocular Safety Testing
  • Section 2: Regulatory Testing Requirements for Ocular Hazards
  • Section 3: Principle of the Low Volume Eye Test
  • Section 4: Performance of the Low Volume Eye Test vs. the Draize Rabbit Eye Test
  • Section 5: Performance of the Low Volume Eye Test vs. the Draize Rabbit Eye Test Considering Human Data and Experience
  • Section 6: Summary
  • Section 7: References
  • Section 8: Glossary

Appendix C: Independent Scientific Peer Review Panel Assessment

  • Appendix C1: Summary Minutes from the Peer Review Panel Meeting on May 19-21, 2009
  • Appendix C2: Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches

Appendix D: ECVAM Scientific Advisory Committee Statement of the Use of Existing LVET Data for Weight of Evidence Decisions on Classification and Labeling of Cleaning Products and Their Main Ingredients

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 U.S. National Toxicology Program website: 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