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Aromatase 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 Aromatase 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, 22K)

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Integrated Summary Report

Integrated Sumary Report for Validation of the Aromatase Assay as a Potential Screen in the Endocrine Disruptor Screening Program Tier-1 Battery (PDF) (223 pp, 2.7M)

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Background Documents

Reference 1. Final Detailed Review Paper on Aromatase Assay (PDF) (93 pp, 316K)

Reference 2. Prevalidation of the Aromatase Assay Using Human, Bovine and Porcine Placental Microsomes and Human Recombinant Microsomes (PDF) (224 pp, 1.7M)

Reference 3. Microsomal Aromatase Prevalidation Supplementary Study: Determine Day to Day and Technician Variability (PDF) (110 pp, 40.6M)

Reference 4. Microsomal Aromatase Prevalidation Supplementary Study: Establish Inhibition Curves and IC50s for Two Reference Chemicals (PDF) (138 pp, 34.3M)

Reference 5. Microsomal Aromatase Prevalidation Supplementary Study: Compare Estrone and Tritiated Water Measurement Methods (PDF) (138 pp, 34.3M)

*NOTE: References 4 and 5 are found in the same document (i.e., PDF file).

Reference 6. Microsomal Aromatase Prevalidation Supplementary Study: Summation of Findings and Revised Aromatase Protocol (PDF) (22 pp, 832K)

Reference 7. Placental Aromatase Assay Validation: Positive Control Study (PDF) (36 pp, 980K)

Placental Aromatase Assay Validation: Appendix A (Battelle Memorial Institute Report) (PDF) (175 pp, 4.6M)

Placental Aromatase Assay Validation: Appendix B (In Vitro Technologies, Inc. Report) (PDF) (178 pp, 6.2M)

Placental Aromatase Assay Validation: Appendix C (WIL Research Laboratories, LLC Report) (PDF) (174 pp, 4.5M)

Placental Aromatase Assay Validation: Appendix D (Draft Interlaboratory Statistical Analysis Report) (PDF) (19 pp, 609K)

Reference 8. Placental Aromatase Assay Validation: Multiple Chemicals Studies with Centrally Prepared Microsomes

Vol. 1 – Draft Final Report & Appendix A (PDF) (387 pp, 36.4M)

Vol. 2 – Appendices B, C, D (PDF) (775 pp, 26.9M)

Reference 9. Placental Aromatase Assay Validation: Prepare Microsomes in Two Participating Laboratories

Vol. 1 – Draft Final Report & Appendix A (PDF) (290 pp, 11M)

Vol. 2 – Appendices B, C, D, E (PDF) (620 pp, 25.5M)

Reference 10. Placental Aromatase Validation Study: Conduct Multiple Chemical Studies with Microsomes Prepared in Participating Laboratories

Vol. 1 - Overall Summary, Appendices A & B (PDF) (960 pp, 44.4M)

Vol. 2 - Appendices C, D, E, F & G (PDF) (1,252 pp, 50.3M)

Reference 11. Human Recombinant Microsomal Aromatase Assay Validation Study: Positive Control Study (PDF) (564 pp, 20.8M)

Reference 12. Recombinant Aromatase Validation Study: Conduct Multiple Chemical Studies With Recombinant Microsomes

Vol. 1 - Overall Summary, Appendices A & B (PDF) (962 pp, 42.8M)

Vol. 2 - Appendices C, D, E, F & G (PDF) (1,230 pp, 43.4M)

Reference 13. Characterization of the Inhibition of Aromatase Activity by Nonylphenol (PDF) (158 pp, 5.2M)

Reference 14. Supplementary Testing of 16 Chemicals in the Recombinant Aromatase Assay (PDF) (717 pp, 13.6M)

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Peer Review Results

Peer Review Results for the Aromatase Assay (PDF) (105 pp, 588K)

EPA Response to Peer Review Comments (PDF) (20 pp, 145K)

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