Test Method Evaluation Report: In Vitro Cytotoxicity Test Methods

Cover of the November 2006 ICCVAM Test Method Evaluation Report on In Vitro Test Methods for Acute Oral ToxicityICCVAM Test Method Evaluation Report (TMER): In Vitro Cytotoxicity Test Methods for Estimating Starting Doses For Acute Oral Systemic Toxicity Testing

November 2006 — NIH Publication No. 07-4519

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Complete Report

Front Matter and Main Body

  • Front Matter
      • Table of Contents
      • List of Tables
      • List of Abbreviations and Acronyms
      • ICCVAM Designated Agency Representatives
      • Acknowledgments
      • Preface
      • Executive Summary
    • Section 1: Introduction
    • Section 2: ICCVAM Recommendations for In Vitro Neutral Red Uptake (NRU) BASAL Cytotoxicity Test Methods
    • Section 3: ICCVAM Recommended Performance Standards
    • Section 4: References

Appendix A - Peer Review Panel Reports

  • Appendix A1 - Peer Review Panel Report: The Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing
  • Appendix A2 - Summary Minutes from Peer Review Panel Meeting on May 23, 2006

Appendix B - Relevant Federal Acute Oral Toxicity Regulations and Testing Guidelines

  • Appendix B1 - Table of Relevant Acute Oral Toxicity Regulations
    Please note: Regulations may be updated in the future. Please check applicable Federal government websites for current versions of U.S. regulations.
  • Appendix B2 - OECD Guideline 425: Acute Oral Toxicity - Up-and-Down Procedure
  • Appendix B3 - OECD Guideline 423: Acute Oral Toxicity - Acute Toxic Class Method
  • Appendix B4 - OECD Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure
  • Appendix B5 - OECD Guidance Document 24: Acute Oral Toxicity Testing

Appendix C - Recommended Test Method Protocols

  • Appendix C1 - Test Method Protocol for the BALB/c 3T3 NRU Cytotoxicity Test Method
  • Appendix C2 - Test Method Protocol for the NHK NRU Cytotoxicity Test Method

Appendix D - Federal Register Notices and Public Comments

  • Appendix D1 - Federal Register Notices
    • 65 FR 37400 - Notice of an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity; Request for Data and Suggested Expert Scientists
    • 65 FR 57203 - Notice of an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity: Workshop Agenda and Registration Information
    • 66 FR 49686 - Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity; Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity; Notice of Availability and Request for Public Comment
    • 69 FR 11448 - Notice of Availability of Agency Responses to ICCVAM Test Recommendations for the Revised Up-and-Down Procedure for Determining Acute Oral Toxicity and In Vitro Methods for Assessing Acute Systemic Toxicity
    • 69 FR 61504 - Availability of Updated Standardized In Vitro Cytotoxicity Test Method Protocols for Estimating Acute Oral Systemic Toxicity; Request for Existing In Vivo and In Vitro Acute Toxicity Data
    • 70 FR 14473 - Request for Nominations for an Independent Peer Review Panel to Evaluate In Vitro Testing Methods for Estimating Acute Oral Systemic Toxicity and Request for In Vivo and In Vitro Data
    • 71 FR 14229 - Announcement of an Independent Scientific Peer Review Meeting on the Use of In Vitro Testing Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests and Request for Comments
    • 71 FR 39122 - Availability of Peer Review Panel Report on the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing and Request for Comments
  • Appendix D2 - ICCVAM Consideration of Public Comments Received in Response to Federal Register Notices

Appendix E - ICCVAM Recommendations from the 2000 International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity