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Test Method Evaluation Report on the BG1Luc ER TA Test Method

Cover of the ICCVAM BG1Luc ER TA Test Method Evaluation ReportICCVAM Test Method Evaluation Report
The LUMI-CELL® ER (BG1Luc ER TA) Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals

NIH Publication No. 11-7850
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Front Matter and Main Body
Front Matter includes Table of Contents, List of Tables, List of Abbreviations and Acronyms, Acknowledgements, Preface, Executive Summary

Main Body Sections:

  • Section 1: Introduction
  • Section 2: ICCVAM Recommendations: Usefulness and Limitations of the BG1Luc ER TA Test Method
    • Background and Introduction
    • ICCVAM Recommendations: Test Method Usefulness and Limitations
    • ICCVAM Recommendations: Test Method Protocol for the the BG1Luc ER TA Test Method
    • ICCVAM Recommendations: Future Studies for the the BG1Luc ER TA Test Method
    • ICCVAM Recommendations: Performance Standards for the the BG1Luc ER TA Test Method
  • Section 3: Validation Status for Use of the BG1Luc ER TA as a Screening Test to Identify In Vitro ER Agonists and Antagonists
  • Section 4: BG1Luc ER TA Test Method Performance Standards
  • Section 5: ICCVAM Consideration of Public Comments
  • Section 6: References

Appendix A: ICCVAM Evaluation of the BG1Luc ER TA (LUMI-CELL®) Test Method – Timeline

Appendix B: Updated ICCVAM-Recommended Protocols: BG1Luc ER TA

Users of the ICCVAM-recommended protocols for the BG1Luc ER TA test method may find the Excel data reporting templates helpful. Please contact NICEATM if you have questions about their use.

Appendix C: Final Background Review Document: Validation Study of the BG1Luc4E2 Estrogen Receptor (ER) Transcriptional Activation (TA) Test Method

Front Matter and Main Body
Front Matter includes Table of Contents, List of Tables, List of Figures, List of Abbreviations and Acronyms, Acknowledgements, Preface, Executive Summary

Main Body Sections:

  • Section 1: Introduction
  • Section 2: BG1Luc ER TA Test Method Protocol Components
  • Section 3: Substances Used for the Validation of the BG1Luc ER TA Test Method
  • Section 4: Test Method Data and Results
  • Section 5: Accuracy of the BG1Luc ER TA Test Method
  • Section 6: Test Method Reliability
  • Section 7: BG1Luc ER TA Data Quality
  • Section 8: Other Scientific Reports
  • Section 9: Animal Welfare Considerations (Reduction, Refinement, and Replacement)
  • Section 10: Practical Considerations
  • Section 11: References
  • Section 12: Glossary
  • Background Review Document Annexes

Appendix D: Independent Scientific Peer Review Panel Assessment

Appendix E: Federal Register Notices and Public Comments

  • Appendix E1: 69 FR 21564 (April 20, 2004): In Vitro Endocrine Disruptor Test Methods: Request for Comments and Nominations

  • Appendix E2: 71 FR 13597: Notice of Availability of a Revised List of Recommended Reference Substances for Validation of In Vitro Estrogen and Androgen Receptor Binding and Transcriptional Activation Assays: Request for Comments and Submission of In Vivo and In Vitro Data

  • Appendix E3: 74 FR 62317 (November 27, 2009): Evaluation of In Vitro Estrogen Receptor Transcriptional Activation and In Vitro Cell Proliferation Assays for Endocrine Disruptor Chemical Screening: Request for Nominations for an Independent Expert Peer Review Panel and Submission of Relevant In Vitro and In Vivo Data

  • Appendix E4: 76 FR 4113 (January 24, 2011): Announcement of an Independent Scientific Peer Review Panel Meeting on an In Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical Screening; Availability of Draft Background Review Document (BRD); Request for Comments

  • Appendix E5: 76 FR 23323 (April 26, 2011): Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)

  • Appendix E6: 76 FR 28781 (May 18, 2011): Independent Scientific Peer Review Panel Report: Evaluation of the Validation Status of an In Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical Screening: Notice of Availability and Request for Public Comments

  • Appendix E7: Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) Comments: SACATM Meeting on June 16-17, 2011

Appendix F: Relevant Endocrine Disruptor Regulations and Testing Guidelines

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