National Toxicology Program

Test Method Evaluation Report: Review of In Vitro Endocrine Disruptor Screening Assays

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

NIH Publication No: 03-4503

Full text of report May 2003
(Please note: This is a large document (8.6 Mb) and may take some time to open.)

Addendum September 2006

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

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

Appendix 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

Appendix C: Expert Panel Evaluation Meeting Agenda

Appendix D: Expert Panel Meeting Minutes

Appendix E. ICCVAM Expert Panel Evaluation Federal Register Notices

1. Request for Data and Nominations of Expert Scientists: 66 FR 16278, March 23, 2001
   (No public comments received in response to this notice)
2. Notice of an Expert Panel Meeting and Request for Comments: 67 FR 16415, April 5, 2002
   View public comments recieved in response to this notice
3. Announcing Availability of Expert Panel Report, Proposed List of Substances and Final Background Review Documents: 67 FR 64902, October 22, 2002
   View public comments recieved in response to this notice