National Toxicology Program

National Toxicology Program
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Test Method Evaluation Report: AMCP Strategy


Cover of the AMCP TMERICCVAM Test Method Evaluation Report on a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products

NIH Publication No. 10-7513

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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 AMCP Testing Strategy
  • Section 3: Validation Status of the AMCP Testing Strategy
  • Section 4: ICCVAM Consideration of Public and SACATM Comments
  • Section 5: References

Appendix A: ICCVAM Evaluation Timeline

Appendix B: ICCVAM-recommended Test Method Protocols

  • Appendix B1: ICCVAM-recommended Bovine Corneal Opacity and Permeability Test Method Protocol
  • Appendix B2: ICCVAM-recommended Cytosensor Microphysiometer Test Method Protocol
  • Appendix B3: ICCVAM-recommended EpiOcular Test Method Protocol

Appendix C: Summary Review Document: Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products Using In Vitro Alternative Methods

  • Front matter: Includes Table of Contents, Acknowledgements, Preface, and Executive Summary
  • Main Body
    • Section 1: Introduction and Rationale for the Use of a Testing Strategy for U.S. Environmental Protection Agency Classification and Labeling of Antimicrobial Cleaning Products
    • Section 2: Testing Strategies for Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products
    • Section 3: Substances Used for Validation of the Testing Strategies for EPA Classification of Antimicrobial Cleaning Products
    • Section 4: In Vivo Reference Data
    • Section 5: Test Method Data and Results
    • Section 6: Test Method Accuracy
    • Section 7: Reliability of the Test Methods Used in the Antimicrobial Cleaning Product Testing Strategy
    • Section 8: Data Quality: Antimicrobial Cleaning Product Background Review Document
    • Section 9: Other Scientific Reports and Reviews
    • Section 10: Animal Welfare Considerations
    • Section 11: Practical Considerations
    • Section 12: References
    • Section 13: Glossary
  • Annex I: Background Review Document of an In Vitro Approach for EPA Toxicity Labeling of Antimicrobial Cleaning Products
    Prepared by the Institute for In Vitro Sciences
  • Annex II: Supplement to a Background Review Document of an In Vitro Approach for EPA Toxicity Labeling of Antimicrobial Cleaning Products
    Prepared by the Institute for In Vitro Sciences
  • Annex III: Composition of Substances Evaluated in the Alternate AMCP Testing Strategy
  • Annex IV: Data Used for the Performance Analysis of the Alternate AMCP Testing Strategy

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
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