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Steroidogenesis H295R Assay Peer Review Materials

EPA announced in a July 2007 Federal Register Notice (PDF) (4 pp, 67K, About PDF) the approach it intends to take for conducting peer reviews of the Tier 1 screening assays and Tier 2 testing assays that are being validated.  As described in the Federal Register Notice, peer review materials will be posted as they become available. Materials may include the documents to be peer reviewed, background documents, the charge to the peer reviewers, and reports that summarize the results of peer reviews. Peer review materials for the Steroidogenesis H295R Assay can be accessed below:

You will need the free Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more. If you need help accessing these PDF documents, please contact William Wooge at 202-564-8476 or wooge.william@epa.gov for assistance.

Charge to Peer Reviewers

Charge to Peer Reviewers (PDF) (2 pp, 16K)

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Interim Final Validation Report

Multi-Laboratory Validation of the H295R Steroidogenesis Assay to Identify Modulators of Testosterone and Estradiol Production (PDF) (91 pp, 1.1MB)

Appendix 1. H295R Cell Culture Protocol

H295R Cell Culture Protocol (PDF) (22 pp, 162K)

Appendix 2. H295R Cell Exposure Protocol

H295R Cell Exposure Protocol (PDF) (25 pp, 221K)

You will need the free Microsoft Excel (XLS) Viewer Exit Disclaimer to view some of the files on this page. If you need help accessing these documents, please contact William Wooge at 202-564-8476 or wooge.william@epa.gov for assistance.

Appendix 3. Data Entry Sheet Template

Data Entry Sheet Template (PDF) (10 pp, 51K)

Appendix 4. Raw data sheets Laboratory 1

Raw data sheets Laboratory 1 (XLS) (352K)

Appendix 5. Raw data sheets Laboratory 2

Raw data sheets Laboratory 2 (XLS) (476K)

Appendix 6. Raw data sheets Laboratory 3

Raw data sheets Laboratory 3 (XLS) (326K)

Appendix 7. Raw data sheets Laboratory 4

Raw data sheets Laboratory 4 (XLS) (246K)

Appendix 8. Raw data sheets Laboratory 5

Raw data sheets Laboratory 5 (XLS) (43K)

Appendix 9. Raw data sheets Laboratory 6

Raw data sheets Laboratory 6 (XLS) (175K)

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Background Documents

Final Report - Development of an Assay Using the H295R Cell Line to Identify Chemical Modulators of Steroidogenesis and Aromatase Activity (PDF) (45 pp, 433K)

Draft Report – Standardization and Refinement of the H295R Cell- Based Assay to Identify Chemical Modulators of Steroidogenesis and Aromatase Activity (Repeat of Inter-Laboratory Study) (PDF) (52 pp, 683K)

Preliminary Report - Response of H295R Cells to the Exposure to Four Model Chemicals (Prochloraz, Aminoglutethimide, Forskolin & Vinclozolin) (PDF) (8 pp, 152K)

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Peer Review Results 

Peer Review Results for the Steroidogenesis H295R Assay (PDF) (77 pp, 311K)

EPA Response to Peer Review Comments (PDF) (9 pp, 47K)

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