National Toxicology Program

Overview Test Method Evaluation Report: AMCP Strategy Test Method Evaluation Report: Low Volume Eye Test Test Method Evaluation Report: AMCP Strategy ICCVAM 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 Download complete report (678 pages, 12 MB) [PDF] Please Note: Large files may take some time to download: times will vary based on the speed of the online connection. The complete report file may not be accessible to all readers; files of individual sections of the report linked below may provide improved accessibility. If you would like assistance in accessing this document, please send an email to the ICCVAM Webmaster [Send Email] or call NICEATM at 919-316-4729.

View Test Method Evaluation Report by Section

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 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 [PDF]

Appendix B: ICCVAM-recommended Test Method Protocols [PDF]

• 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 [PDF]

• 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
  • Main Body [PDF]
  • Submission Cover Letter from IIVS, Inc. [PDF]
  • Background Review Document Annexes available on request - please contact NICEATM
• Annex II: Supplement to a Background Review Document of an In Vitro Approach for EPA Toxicity Labeling of Antimicrobial Cleaning Products [PDF]
  Prepared by the Institute for In Vitro Sciences
• Annex III: Composition of Substances Evaluated in the Alternate AMCP Testing Strategy [PDF]
• Annex IV: Data Used for the Performance Analysis of the Alternate AMCP Testing Strategy [PDF]

Appendix D: Independent Scientific Peer Review Panel Assessment

• Appendix D1: Summary Minutes from the Peer Review Panel Meeting on May 19-21, 2009 [PDF]
• Appendix D2: Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of Alternative Ocular Safety Testing Methods and Approaches [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
  • Responses to 70 FR 13512
  • Responses to 72 FR 26396
  • Responses to 72 FR 31582 (no responses received)
  • Responses to 73 FR 18535
  • Responses to 74 FR 14556
  • Responses to 74 FR 8974
    • Humane Society of the United States/Humane Society Legislative Fund [PDF]
    • Sharon Meyer, PhD, University of Louisiana at Monroe [PDF]
    • People for the Ethical Treatment of Animals [PDF]
  • Responses to 74 FR 33444 (no responses received)


• 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

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
• Appendix F4: Organisation for Economic Co-operation and Development Test Guideline 405: Acute Eye Irritation/Corrosion [PDF]