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Test Method Evaluation Report

Test Method Evaluation Report

ICCVAM Final Report: ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)

National Toxicology Program (NTP) Interagency Center for
the Evaluation of Alternative Toxicological Methods (NICEATM)

National Institute of Environmental Health Sciences
National Institutes of Health
U.S. Public Health Service
Department of Health and Human Services

NIH Publication No: 03-4503
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Full text of report May 2003 [PDF - 8.6 MB]

Addendum September 2006 [PDF - 2.0 MB]

Table of Contents

ICCVAM - NICEATM Overview
Table of Contents
List of Tables
List of Abbreviations and Acronyms
ICCVAM Representatives
Acknowledgements
Preface
Executive Summary
  1. ICCVAM Evaluation and Recommendations on Estrogen and Androgen Receptor Binding and Transcriptional Activation Assays
    1. Introduction
    2. ICCVAM Proposed Substances for Validation of In Vitro Endocrine Disruptor Assays
    3. Public Comments
    4. ICCVAM Recommendations

  2. Proposed Substances and Selection Criteria for Validation of In Vitro Endocrine Disruptor Screening Assays
    1. Introduction
    2. Draft Background Review Document Recommendations
    3. Expert Panel Recommendations on Proposed Substances for Validation Studies
    4. ICCVAM, EDWG and NICEATM Proposed List of Substances for Validation

  3. In Vitro Estrogen Receptor Binding Assays
    1. Minimum Procedural Standards
    2. Recommended Substances for Validation of In Vitro Estrogen Receptor Binding Assays

  4. In Vitro Estrogen Receptor Transcriptional Activation Assays
    1. Minimum Procedural Standards
    2. Recommended Substances for Validation of In Vitro Estrogen Receptor Transcriptional Activation Assays

  5. In Vitro Androgen Receptor Binding Assays
    1. Minimum Procedural Standards
    2. Recommended Substances for Validation of In Vitro Androgen Receptor Binding Assays

  6. In Vitro Androgen Receptor Transcriptional Activation Assays
    1. Minimum Procedural Standards
    2. Recommended Substances for Validation of In Vitro Androgen Receptor Transcriptional Activation Assays

  7. References

Appendices

A. Expert Panel Evaluation of the Validation Status of In Vitro Test Methods for Detecting Endocrine Disruptors

B. Evaluation Guidance to the Expert Panel for the Review of In Vitro Test Methods for Detecting Endocrine Disruptors

  1. Evaluation Guidance for Estrogen Receptor and Androgen Receptor Binding Assays
  2. Evaluation Guidance for Estrogen Receptor and Androgen Receptor Transcriptional Activation Assays

C. Expert Panel Evaluation Meeting Agenda

D. Expert Panel Meeting Minutes

E. ICCVAM Expert Panel Evaluation Federal Register Notices

  1. Vol. 66, No. 57, pp. 16278-16279, March 23, 2001
    Request for Data and Nominations of Expert Scientists
  2. Vol. 67, No. 66, pp. 16415-16416, April 5, 2002
    Notice of an Expert Panel Meeting and Request for Comments
  3. Vol. 67, No. 204, pp. 64902-64903, October 22, 2002
    Announcing Availability of Expert Panel Report, Proposed List of Substances and Final Background Review Documents

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