Test Method Evaluation Report
ICCVAM 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 [PDF]
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
[PDF]
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.
Download Excel viewer 
Appendix C: Final Background Review Document:
Validation Study of the BG1Luc4E2 Estrogen Receptor (ER) Transcriptional Activation (TA) Test Method
Front Matter and Main Body [PDF]
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 D1: Summary Minutes from the Independent Scientific Peer Review Panel Meeting on March 29-30, 2011
[PDF]
- Appendix D2: Independent Scientific Peer Review Panel Report:
Evaluation of the LUMI-CELL® ER (BG1Luc ER TA) Test Method
[PDF]
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
- Federal Register Notice
[PDF]
- Responses to 69 FR 21564 (no responses received)
- 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
- Federal Register Notice
[PDF]
- Responses to 71 FR 13597 (no responses received)
- 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
- Federal Register Notice
[PDF]
- Responses to 76 FR 28781 (no responses received)
- Appendix E7: Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) Comments: SACATM Meeting on June 16-17, 2011
[PDF]
Appendix F: Relevant Endocrine Disruptor Regulations and Testing Guidelines
- Appendix F1: Table of Relevant Endocrine Disruptor Test Regulations [PDF]
Note: Regulations may be updated in the future. It is recommended that users review the most current version of all regulations identified.
Link to United States Code on U.S. Government Printing Office website
Link to U.S. Code of Federal Regulations on
U.S. Government Printing Office website
- Appendix F2: EPA Endocrine Disruptor Screening Program Test Guideline OPPTS 890.1300:
Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903)) (October 2009)
[PDF]
- Appendix F3: OECD Test Guideline 455:
Stably Transfected Human Estrogen Receptor-α
Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals (Adopted September 2009)
[PDF]
- Appendix F4: Weight of Evidence Guidance: Evaluating Results of EDSP Tier 1
Screening to Identify Candidate Chemicals For Tier 2 Testing
(Draft for Public Comment)
[PDF]
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