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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:

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, 17K)

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Integrated Summary Report

Integrated Summary Report for the Validation of the Male Pubertal Rat Assay as a Potential Screen in the Endocrine Disruptor Screening Program Tier-1 Battery (PDF) (128pp, 550K)

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Background Documents

Appendix 1. Male Pubertal Protocol

Protocol for the Male Pubertal Rat Assay (PDF) (19pp, 111K)

Explanation of the 5 Thyroid Slides (attached below) and How they are Used in the Protocol for the Male 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 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 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.

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 Data

Ashby 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

Summary Report of Transferability Study (Block 1) - TherImmune Research Corporation: Assessment of Pubertal Development and Thyroid Function in Juvenile Male Rats (PDF) (190pp, 5M)

Summary Report of Transferability Study (Block 2) - TherImmune Research Corporation: Assessment of Pubertal Development and Thyroid Function in Juvenile Male Rats (PDF) (198pp, 5.4M)

Appendix 5. Transferability Study (TherImmune 1) Detailed Table of Results

Detailed Table of Results from Transferability Study - TherImmune Research Corporation: Assessment of Pubertal Development and Thyroid Function in Juvenile Male Rats (XLS) (39pp, 239K)

Appendix 6. Multi-Chemical Study (RTI) Summary Report

Summary Report from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Male CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 23 to 52/53 (PDF) (972pp, 16.1M)

Final Pathology Report from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Male CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 23 to 52/53 (PDF) (62pp, 5.2M)

Feed Analysis Reports from the RTI Multi-Chemical Study - Assessment of Pubertal Development and Thyroid Function in Juvenile Male CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 23 to 52/53 (PDF) (8pp, 388K)

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 Male CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 23 to 52/53 (PDF) (1pp, 8K)

Appendix 7. 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 Male CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 23 to 52/53 (XLS) (13pp, 121K)

Appendix 8. 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 Male CD® (Sprague-Dawley) Rats After Exposure to Selected Chemicals Administered by Gavage on Postnatal Days 23 to 52/53 (PDF) (274pp, 353K)

Appendix 9. Multi-Dose Study (TherImmune 2) Summary Report

Final Report from 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) (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 10. 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) (13pp, 121K)

Appendix 11. 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) (72pp, 121K)

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)

Battelle Report on the Analysis of the Interlaboratory Validation of the Male Pubertal Assay: Assessment of Pubertal Development and Thyroid Function in Juvenile Male Rats (PDF) (127pp, 13.5M)

Appendix 18. 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 Male Pubertal Assay: Assessment of Pubertal Development and Thyroid Function in Juvenile Male Rats (PDF) (18pp, 276K)

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)

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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)

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