Jump to main content.


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)

Top of page


Integrated Summary Report

Integrated Summary Report for Validation of a Test Method for Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats as a Potential Screen in the Endocrine Disruptor Screening Program Tier-1 Battery (PDF) (122pp, 351K)

Top of page


Background Documents

Appendix 1. Male Pubertal Protocol

Protocol for the Female Pubertal Rat Assay (PDF) (19pp, 91K)

Explanation of the 5 Thyroid Slides (attached below) and How they are Used in the Protocol for the Female Pubertal Assay (PDF) (1pp, 8K)

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 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.

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

Final Report from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Female CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 22 to 42/43 (PDF) (182pp, 543K)

Pathology Report from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Female CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 22 to 42/43 (PDF) (52pp, 16.9M)

Feed Analysis Reports from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Female CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 22 to 42/43 (PDF) (5pp, 239K)

Caveat regarding the Analysis of the Covariance in Organ Weights in the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Female CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 22 to 42/43 (PDF) (1pp, 8K)

Appendix 6. Multi-Chemical Study (RTI) Detailed Table of Results

Detailed Table of Results from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Female CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 22 to 42/43 (XLS) (11pp, 115K)

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

Analysis of Covariance (ANCOVA) with Body Weight at Weaning of Data from the RTI Multi-Chemical Study Report - Assessment of Pubertal Development and Thyroid Function in Juvenile Female CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 22 to 42/43 (PDF) (33pp, 48K)

Appendix 8. Multi-Dose Study (TherImmune 2) Summary Report

Final Report - Pubertal Toxicity Study of Vinclozolin, Flutamide and Phenobarbital in Male Sprague Dawley Rats and Methoxychlor, Ethinyl Estradiol and Phenobarbital in Female Sprague Dawley Rats when Administered in Corn Oil by Oral Gavage (PDF) (844pp, 14.7M)

Caveat regarding the Analysis of the Covariance in Terminal Body Weights in the TherImmune Research Corporation Pubertal Toxicity Study of Vinclozolin, Flutamide and Phenobarbital in Male Sprague Dawley Rats and Methoxychlor, Ethinyl Estradiol and Phenobarbital in Female Sprague Dawley Rats when Administered in Corn Oil by Oral Gavage (PDF) (1pp, 8K)

Appendix 9. Multi-Dose Study (TherImmune 2) Detailed Table of Results

Detailed Table of Results from TherImmune Research Corporation Report Study Pubertal Toxicity Study of Vinclozolin, Flutamide and Phenobarbital in Male Sprague Dawley Rats and Methoxychlor, Ethinyl Estradiol and Phenobarbital in Female Sprague Dawley Rats when Administered in Corn Oil by Oral Gavage (XLS) (16pp, 74K)

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

Analysis of Covariance (ANCOVA) with Body Weight at Weaning of Data from the TherImmune Research Corporation Report Study Pubertal Toxicity Study of Vinclozolin, Flutamide and Phenobarbital in Male Sprague Dawley Rats and Methoxychlor, Ethinyl Estradiol and Phenobarbital in Female Sprague Dawley Rats when Administered in Corn Oil by Oral Gavage (PDF) (4pp, 58K)

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)

Battelle Report on the Analysis of the Interlaboratory Validation of the Female Pubertal Assay Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats (PDF) (225pp, 7M)

Appendix 17. Interlaboratory Validation Study Detailed Table of Results

Detailed Table of Results Extracted from the Battelle Report on the Analysis of the Interlaboratory Validation of the Female Pubertal Assay Assessment of Pubertal Development and Thyroid Function in Juvenile Female Rats (XLS) (13pp, 148K)

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)

Top of page


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)

Top of page


 


Local Navigation


Jump to main content.