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

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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 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