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Amphibian Metamorphosis 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 Amphibian Metamorphosis 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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Integrated Summary Report

Integrated Summary Report for Validation of a Test Method that Assesses the Potential of Chemicals to Interfere with HPT Axis Structure and Function, as a Potential Screen in the Endocrine disruptor Screening Program Tier 1 Battery (PDF) (95pp, 774 K)

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Background Documents

Attachment A: Test Method for the Amphibian Metamorphosis Assay (ZIP) (3 files, 4.8M)

Test Method for the Amphibian Metamorphosis Assay (PDF) (26pp, 224K)

Appendix 1 for the Test Method of the Amphibian Metamorphosis Assay - Guidance Document on Amphibian Thyroid Histology Part 1: Technical Guidance for Morphologic Sampling and Histological Preparation (PDF) (16pp, 215K)

Appendix 2 for the Test Method of the Amphibian Metamorphosis Assay - Guidance Document on Amphibian Thyroid Histology Part 2: Approach to Reading Studies, Diagnostic Criteria, Severity Grading, and Atlas (PDF) (47pp, 4.24M)

Attachment B: Final Report of the Validation of the Amphibian Metamorphosis Assay for the Detection of Thyroid Active Substances: Phase 1, Optimisation of the Test Protocol

Final Report for Phase 1 of the Validation of the Amphibian Metamorphosis Assay (PDF) (90pp, 717K)

Attachment C: Final Report of the Validation of the Amphibian Metamorphosis Assay: Phase 2 - Multi-Chemical Interlaboratory Study

Final Report for Phase 2 of the Validation of the Amphibian Metamorphosis Assay (PDF) (96pp, 790K)

Attachment D: Draft Report of the Phase 3 of the Validation of the Amphibian Metamorphosis Assay

Draft Report of the Phase 3 of the Validation of the Amphibian Metamorphosis Assay (PDF) (73pp, 320 K)

Attachment E: Detailed Review Paper for the Amphibian Metamorphosis Assay

OECD Detailed Review Paper for the Amphibian Metamorphosis Assay (PDF) (106pp, 522K)

Attachment F: Endocrine Disruptor Screening Program Validation Paper

Paper Describing EDSP's Approach to Validation for the Tier 1 Screening Battery (PDF) (21pp, 131K)

Attachment G: Power Analysis for Determining Study Design for the Amphibian Metamorphosis Assay

Power Analysis Within the Proposal for Phase 1 of Validation of the Amphibian Metamorphosis Assay (PDF) (66pp, 1.72M)

Attachment H : Final Report (Battelle) for the Multi-Chemical Study (ZIP) (2 files, 32.5M)

Final report for the Multi-Chemical Study Performed by a Contractor for the Amphibian Metamorphosis Assay Validation (PDF) (54pp, 355K)

Appendices to the Final Report (Battelle) for the Multi-Chemical Study (PDF) (903pp, 34.7M)

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Peer Review Results

Peer Review Results for the Amphibian Metamorphosis Assay (PDF) (181 pp, 715K)

EPA Response to Peer Review Comments (PDF) (40 pp, 397K)

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