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Pubertal Male Rat 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 Pubertal Male Rat Assay can be accessed below:
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Charge to Peer Reviewers
Charge to Peer Reviewers (PDF) (2 pp, 17K)
Integrated Summary Report
Background Documents
Appendix 1. Male Pubertal Protocol
Protocol for the Male Pubertal Rat Assay (PDF) (19pp, 111K)
Image of Slide 30576F1C5 (see above) (PDF) (1pp, 374K)
Image of Slide 30590F3C3 (see above) (PDF) (1pp, 424K)
Image of Slide 30593F4C2 (see above) (PDF) (1pp, 420K)
Image of Slide 30594F5C1 (see above) (PDF) (1pp, 434K)
Image of Slide 30648F2C4 (see above) (PDF) (1pp, 413K)
Appendix 2. Detailed Review Paper
The detailed review paper for the Male Pubertal Rat Assay, Endocrine-disrupting chemicals: prepubertal exposures and effects on sexual maturation and thyroid function in the male rat. A focus on the EDSTAC recommendations is copyrighted material and cannot be disseminated.If you wish to locate a copy of the paper, please use the following citation:
Stoker, T. E., Parks, L. G., Gray, L. E., and Cooper, R. L. (2000). Endocrine-disrupting chemicals: prepubertal exposures and effects on sexual maturation and thyroid function in the male rat. A focus on the EDSTAC recommendations. Crit Rev.Toxicol. 30, 197-252.
Appendix 3. Literature Studies since the Detailed Review Paper
You will need the free Microsoft Excel (XLS) Viewer 
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.
Table of Literature Studies since the Detailed Review Paper (PDF) (5pp, 75K)
List of References from which Data were Extracted by Contractor for the Male Pubertal Assay: Pubertal Assays since 2000 (PDF) (2pp, 5K)
Extracted DataAshby and Lefevre (2000) (XLS) (12pp, 340K)
Blystone et al 2007 (XLS) (12pp, 75K)
Grote et al 2004 (XLS)(10pp, 57K)
Marty et al 2001a (XLS) (12pp, 67K)
Marty et al 2001b (XLS) (12pp, 75K)
Romualdo et al 2002 (XLS) (11pp, 34K)
Shin et al 2002 (XLS) (11pp, 40K)
Stoker et al 2000 (XLS) (10pp, 49K)
Stoker et al 2002 (XLS) (10pp, 86K)
Stoker et al 2004 (XLS) (10pp, 65K)
Stoker et al 2005 (XLS) (10pp, 35K)
Stoker et al 2006 (XLS) (11pp, 45K)
Tan et al 2003 (XLS) (11pp, 40K)
Yamasaki et al 2002 (XLS) (11pp, 37K)
Appendix 4. Transferability Study (TherImmune 1) Summary Report
Appendix 5. Transferability Study (TherImmune 1) Detailed Table of Results
Appendix 6. Multi-Chemical Study (RTI) Summary Report
Appendix 7. Multi-Chemical Study (RTI) Detailed Table of Results
Appendix 8. Multi-Chemical Study (RTI) ANCOVA with Body Weight at Weaning
Appendix 9. Multi-Dose Study (TherImmune 2) Summary Report
Appendix 10. Multi-Dose Study (TherImmune 2) Detailed Table of Results
Appendix 11. Multi-Dose Study (TherImmune 2) ANCOVA with Body Weight at Weaning
Appendix 12. White Paper on Rat Strain Differences
White Paper on Species/Strain/Stock in Endocrine Disruptor Assays (PDF) (97pp, 563K)
Appendix 13. Reviewer's Comments on White Paper on Rat Strain Differences
Reviewer’s Appendix to the White Paper on Species/Stock/Strain in Endocrine Disruptor Assays (PDF) (97pp, 546K)
Appendix 14. Interlaboratory Validation Study Summary Report (Charles River/Argus)
Summary Report for the CR-DDS Argus Division’s Interlaboratory Validation of the Male Pubertal Assay (PDF) (48pp, 311K)
Appendix 15. Interlaboratory Validation Study Summary Report (Huntingdon)
Summary Report for the Huntingdon Life Science’s Interlaboratory Validation of the Male Pubertal Assay (PDF) (49pp, 1.9M)
Appendix 16. Interlaboratory Validation Study Summary Report (WIL)
Summary Report for the WIL Research Laboratories’ Interlaboratory Validation of the Male Pubertal Assay (PDF) (59pp, 651K)
Appendix 17. Interlaboratory Validation Study Analysis Report (Battelle)
Appendix 18. Interlaboratory Validation Study Detailed Table of Results
Appendix 19. Interlaboratory Validation Study Comparison of Results Table
Table with the Comparison of Results from the Male Pubertal Interlaboratory Validation Study (PDF) (18pp, 115K)
Peer Review Results
Peer Review Results for the Pubertal Male Rat Assay (PDF) (80 pp, 355K)
EPA Response to Peer Review Comment (PDF) (52 pp, 188K)