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In Vitro Testing Strategy for Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products
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Low Volume Eye Test

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
Download complete report (296 pages, 5.1 MB) [PDF]

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 Cover of the LVET TMER

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Front Matter [PDF]
Includes Table of Contents, Lists of Tables and Figures, List of Abbreviations and Acronyms, Acknowledgements, Preface, and Executive Summary

Main Body [PDF]

  • 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 [PDF]

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

  • 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 [PDF]
  • Appendix C2: Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches [PDF]

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 [PDF]

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 [PDF]
    • 72 FR 26396 (May 9, 2007): Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing [PDF]
    • 72 FR 31582 (June 7, 2007): Request for Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies Using Standardized Testing Methods [PDF]
    • 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 [PDF]
    • 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 [PDF]
    • 74 FR 8974 (April 29, 2009): Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) [PDF]
    • 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 [PDF]

  • 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 [PDF]
    Full meeting minutes available on U.S. National Toxicology Program website: refer to materials for 2009 meeting Exiting the ICCVAM website

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 [PDF]
  • Appendix F2: U.S. Environmental Protection Agency Health Effects Test Guidelines: OPPTS 870.2400 - Acute Eye Irritation [PDF]
  • Appendix F3: U.S. Environmental Protection Agency Office of Pesticide Programs Label Review Manual
    View on U.S. Environmental Protection Agency website Exiting the ICCVAM website
  • Appendix F4: Organisation for Economic Co-operation and Development Test Guideline 405: Acute Eye Irritation/Corrosion PDF]
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