![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Pubertal Female 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 Female Rat 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)
Integrated Summary Report
Background Documents
Appendix 1. Male Pubertal Protocol
Protocol for the Female Pubertal Rat Assay (PDF) (19pp, 91K)
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 Female Pubertal Rat Assay Endocrine-Disrupting Chemicals: Prepubertal Exposures and Effects on Sexual Maturation and Thyroid Activity in the Female 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:
Goldman, J.M., Laws, S.C., Balchak, S.K., Cooper, R.L., Kavlock, R.J.. (2000). Endocrine-Disrupting Chemicals: Prepubertal Exposures and Effects on Sexual Maturation and Thyroid Activity in the Female Rat. A Focus on the EDSTAC Recommendations. Crit Rev.Toxicol. 30(2), 135-196.
Appendix 3. Transferability Study (TherImmune 1) Summary Report
Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats (Study 101) (PDF) (184pp, 4.7M)
Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats (Study 103) (PDF) (184pp, 4.8M)
Appendix 4. Transferability Study (TherImmune 1) Detailed Table of Results
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.
Detailed Table of Results from Transferability Study - TherImmune Research Corporation Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats (XLS) (5pp, 179K)
Appendix 5. Multi-Chemical Study (RTI) Summary Report
Appendix 6. Multi-Chemical Study (RTI) Detailed Table of Results
Notes for Appendix 6 - Multi-chemical study - RTI - Summary Table (PDF) (4pp, 16K)
Appendix 7. Multi-Chemical Study (RTI) ANCOVA with Body Weight at Weaning
Appendix 8. Multi-Dose Study (TherImmune 2) Summary Report
Appendix 9. Multi-Dose Study (TherImmune 2) Detailed Table of Results
Notes for Appendix 9 - Multi-dose study - TherImmune 2 - Summary Table (PDF) (4pp, 20K)
Appendix 10. Multi-Dose Study (TherImmune 2) ANCOVA with Body Weight at Weaning
Appendix 11. White Paper on Rat Strain Differences
White Paper on Species/Strain/Stock in Endocrine Disruptor Assays (PDF) (97pp, 563K)
Appendix 12. 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 13. Interlaboratory Validation Study Summary Report (Charles River/Argus)
Summary Report for the CR-DDS Argus Division's Interlaboratory Validation of the Female Pubertal Assay (PDF) (38 pp., 311KB)
Appendix 14. Interlaboratory Validation Study Summary Report (Huntingdon)
Summary Report for the Huntingdon Life Science's Interlaboratory Validation of the Female Pubertal Assay (PDF) (51 pp, 1.9M)
Appendix 15. Interlaboratory Validation Study Summary Report (WIL)
Summary Report for the WIL Research Laboratories' Interlaboratory Validation of the Female Pubertal Assay (PDF) (53 pp, 850K)
Appendix 16. Interlaboratory Validation Study Analysis Report (Battelle)
Appendix 17. Interlaboratory Validation Study Detailed Table of Results
Appendix 18. Interlaboratory Validation Study Comparison of Results Table
Table with the Comparison of Results from the Female Pubertal Interlaboratory Validation Study (PDF) (10pp, 81K)
Peer Review Results
Peer Review Results for the Female Pubertal Rat Assay (PDF) (106 pp, 424K)
EPA Response to Peer Review Comments (PDF) (82 pp, 287K)