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Estrogen Receptor Binding Assay Using Rat Uterine Cytosol (ER-RUC) 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 Estrogen Receptor (ER) Binding 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) (2pp, 33K)

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Integrated Summary Report

Integrated Summary Report for Validation of an Estrogen Receptor Binding Assay using Rat Uterine Cytosol as Source of Receptor as a Potential Screen in the Endocrine Disruptor Screening Program Tier 1 Battery (PDF) (94pp, 553K)

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Background Documents

Appendix 1. Estrogen Receptor Binding (RUC) Assay Protocol
Protocol for the Estrogen Receptor Binding Assay using rat uterine cytosol (PDF) (94pp, 444K)

Appendix 2. Background Review Document (excerpts)
Executive summary, conclusions, and recommendations from Background Review Document: Current status of test methods for detecting endocrine disruptors – in vitro estrogen receptor binding assays. ICCVAM 2002. (PDF) (65pp, 32K)

Appendix 3. Standardized Approach for Testing Low Solubility Chemicals
Development of a standardized approach for evaluating environmental chemicals with low solubility in the estrogen receptor (ER) binding assay (PDF) (7pp, 230K)

Appendix 4. Statistical Methods Report
Report on statistical methods for evaluating variability and setting up performance criteria for receptor binding assays (PDF) (27pp, 802K)

Appendix 5. Second Interlaboratory Validation Study: Laboratory Summary Report
Summary report covering all three laboratories in the second interlaboratory validation study of the ER-RUC assay (PDF) (130pp, 4.27M)

Appendix 6. Second Interlaboratory Validation Study: Lab X Data and Report
Lab X’s data and report from the second interlaboratory validation study of the ER-RUC assay (PDF) (184pp, 4.34M)

Appendix 7. Second Interlaboratory Validation Study: Lab Y Data and Report
Lab Y’s data and report from the second interlaboratory validation study of the ER-RUC assay (PDF) (279pp, 3.07M)

Appendix 8. Second Interlaboratory Validation Study: Lab Z Data and Report
Lab Z’s data and report from the second interlaboratory validation study of the ER-RUC assay (PDF) (664pp, 151M)

Appendix 9. Second Interlaboratory Validation Study: Uniform Statistical Analysis
Methods and results of the uniform statistical analysis of the second interlaboratory validation study of the ER-RUC assay (PDF) (138pp, 1.02M)

Appendix 10. Second Interlaboratory Validation Study: Lab X Data (Re-nomralized, Outliers Excluded)
Lab X data, re-normalized and fit with outliers excluded (PDF) (54pp, 269K)

Appendix 11. Second Interlaboratory Validation Study: Lab Y Data (Re-nomralized, Outliers Excluded)
Lab Y data, re-normalized and fit with outliers excluded (PDF) (149pp, 865K)

Appendix 12. Second Interlaboratory Validation Study: Lab Z Data (Re-nomralized, Outliers Excluded)
Lab Z data, re-normalized and fit with outliers excluded (PDF) (93pp, 660K)

Appendix 13. Second Interlaboratory Validation Study: Superimposed Graphs of Acceptable Runs
Superimposed graphs of acceptable runs for reference standard (estradiol), weak positive (norethynodrel), and test chemicals, by laboratory (PDF) (29pp, 1.15M)

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Peer Review Results

Peer Review Results for the Estrogen Receptor Binding Assay Using Rat Uterine Cytosol (ER-RUC) Assay (PDF) (81pp, 362K)

EPA Response to Peer Review Comments (55 pp, 206K)


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