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Assay Status Table

The assay status table provides information for each of the assays in each stage of the validation process. The assay validation process is composed of five steps:

EPA announced 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 well as EPA’s approach for conducting the peer review of the Tier 1 battery in a July 2007 Federal Register Notice (PDF) (4pp, 67K).

In response to stakeholder questions regarding technical aspects of the EDSP Tier 1 assays, EPA has developed a clarification document (PDF) (37pp, 622K) to answer these questions.

A fact sheet for each assay, if available, can be accessed by clicking on the assay name in the table below. Note that information related to scientific peer review and regulatory acceptance and implementation will be posted when it becomes available.

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.

Assay Title

Assay Development

Pre-Validation

Validation and Peer Review

Amphibian Metamorphosis (Tier 1) (PDF) (3pp, 124K)

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Revised Draft Detailed Review Paper (PDF) (93pp, 424K)

Revised Draft Detailed Review Paper Appendix A (PDF) (86pp, 304K)

Revised Draft Detailed Review Paper Appendix B (PDF) (11pp, 161K)

OECD Detailed Review Paper (PDF) (106pp, 521K)

OECD Draft Report of the Validation of the Amphibian Metamorphosis Assay for the Detection of Thyroid Active Substances: Phase 1 - Optimisation of the Test Protocol (PDF) (83pp, 2.8M)

-- U.S. Pathology Report for PTU (PDF) (18pp, 522K)

-- Japan Histology Results for 14-day PTU Assay (PDF) (3pp, 57K)

-- Germany Thyroid Histology Report (PDF) (17pp, 972K)

Integrated Summary Report (PDF) (95pp, 774 K)

Peer Review Results for the Amphibian Metamorphosis Assay (PDF) (181pp, 715K)

EPA Response to Peer Review Comments (PDF) (40pp, 397K)

Androgen Receptor (AR) Binding (Tier 1) (PDF) (2pp, 85K)

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ICCVAM Evaluation of In Vitro - AR Binding and Transcriptional Activation

Expert Panel Evaluation of the Validation Status - AR Binding and Transcriptional Activation

ICCVAM-NICEATM Executive Summary- Current Status of Test Methods (PDF) (6pp, 22K)

ICCVAM-NICEATM Transcriptional Activation Executive Summary (PDF) (6pp, 22K)

Integrated Summary Report (PDF) (236pp, 9.1M)

Peer Review Results for the AR Binding Assay (PDF) (77pp, 311K)

EPA Response to Peer Review Comments (PDF) (9pp, 47K)

Aromatase (Tier 1) (PDF) (2pp, 93K)

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Final Detailed Review Paper (PDF) (93pp, 314K)

Pre-validation Study Plan and Protocol Using Human, Bovine, and Porcine Placenta, and Human Recombinant Microsomes (PDF) (18pp, 13K)

Phase I Pre-Optimization Experiments for Substrate Characterization for Porcine Microsomes (PDF) (6pp, 141K)

Letter Report on Phase I Pre-Optimization Experiments for Substrate Characterization for Bovine Placental Microsomes (PDF) (5pp, 130K)

Letter Report on Phase I Pre-Optimization Experiments for Substrate Characterization for Human Recombinant and Human Placental Microsomes (PDF) (13pp, 1.15M)

Human Placental and Recombinant Data:

-- Aromatase Optimization Supplementary Studies - Experiment #1 (PDF) (29pp, 237K)

-- Estrogen Production in Human Placental Assay Results (PDF) (28pp, 218K)

-- Figure 9 - Graphic Representation of Control Means and Standard Deviations (PDF) (4pp, 1.2M)

-- Figure 10 - Placental Aromatase Response Curves (PDF) (5pp, 1.5M)

-- Figure 11- Recombinant Aromatase Assay Response Curves (PDF) (5pp, 1.5M)

Integrated Sumary Report (PDF) (223pp, 2.7M)

Peer Review Results for the Aromatase Assay (PDF) (105pp, 588K)

EPA Response to Peer Review Comments (PDF) (20pp, 145K)

Estrogen Receptor (ER) Binding (Tier 1) (PDF) (2pp, 117K)

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ICCVAM Evaluation of In Vitro - AR Binding and Transcriptional Activation

Expert Panel Evaluation of the Validation Status - AR Binding and Transcriptional Activation

ICCVAM-NICEATM Executive Summary-Current Status of Test Methods (PDF) (7pp, 22K)

ICCVAM-NICEATM Transcriptional Activation Executive Summary (PDF) (6pp, 22K)

Integrated Summary Report (ISR) (PDF) (94pp, 553K)

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

Fish Screen (Tier 1) (PDF) (3pp, 97K)

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Draft Detailed Review Paper (PDF) (123pp, 992K)

U.S. EPA/ORD Report: Short-term Test Method (PDF) (170pp, 7.3M) or HTML version

OECD Detailed Review Paper (PDF) (170pp, 909K)

Draft Study Plan on the Comparative Evaluation (Fathead) (PDF) (31pp, 362K)

Draft Study Plan on the Comparative Evaluation (Vitellogenin) (PDF) (9pp, 171K)

Draft Final Report on Comparative Evaluation of the Fathead Minnow:

-- Section 1 and 2: Introduction and Methods (PDF) (49pp, 1.72M)

-- Section 3: Methoxychlor (PDF) (69pp, 472K)

-- Section 4: Trenbolone (PDF) (62pp, 1M)

-- Section 5: Flutamide (PDF) (64pp, 900K)

-- Section 6: Fadrozole (PDF) (67pp, 780K)

-- Section 7-8: Discussion and References (PDF) (13pp, 250K)

Draft Final Report on Comparative Evaluation of Vitellogenin Methods in Fathead Minnow (PDF) (51pp, 519K)

Draft Final Report on Survey of Vitellogenin Methods in Zebrafish and Medaka (PDF) (34pp, 954K)

OECD Proposed Guideline Nov 2002 (PDF) (18pp, 346K)

Draft Final Report on Multi-Chemical Evaluation of the Short-Term Reproduction Assay with the Fathead Minnow (PDF) (165pp, 925K)

Best Practices Guideline: Toxicologic Histopathology (PDF) (6pp, 63K)

Ankley/Johnson Review Paper: Small Fish Models for Identifying and Assessing the Effects of Endocrine-disrupting Chemicals (PDF) (15pp, 228K)

Integrated Summary Report (PDF) (104pp, 461K)

OECD Revised Draft Report Phase 1B of the Validation of the 21-day Fish Assay for the Detection of Endocrine Active Substances (PDF) (92pp, 754K)

Peer Review Results for the Fish Short-Term Reproduction (Fish Screen) Assay (PDF) (110pp, 491K)

EPA Response to Peer Review Comments (PDF) (26pp, 249K)

Hershberger (Tier 1) (PDF) (2pp, 90K)

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Final OECD Report of the Initial Work Towards the Validation of the Rat Hershberger Assay: Phase-1: Androgenic Response To Testosterone Propionate, And Anti-Androgenic Effects of Flutamide (PDF) (209pp, 1.8M)

Draft Report of the OECD Validation of the Rat Hershberger Bioassay: Phase-2: Testing of Androgen Agonists, Androgen Antagonists and a 5α-Reductase Inhibitor in Dose Response Studies by Multiple Laboratories (PDF) (110pp, 780K)

Draft Report of the OECD Validation of the Rat Hershberger Bioassay: Phase 3: Coded Testing of Androgen Agonists, Androgen Antagonists and Negative Reference Chemicals by Multiple Laboratories. Surgical Castrate Model Protocol (PDF) (145pp, 1.8M)

Draft OECD Guideline for the Testing of Chemicals: The Hershberger Bioassay in Rats (PDF) (17pp, 184K)

Male Pubertal (Tier 1) (PDF) (2pp, 89K)

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Detailed Review Paper equivalent (males). (Stoker TE et al. 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(2):197-252)

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)

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)

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)

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)

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)

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)

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)

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)

Restricted feeding study (Laws SC et al. 2007. Effects of altered food intake during pubertal development in male and female Wistar rats. Toxicol Sci 100(1):194-202).

Integrated Summary Report (PDF) (128pp, 550K)

Interlaboratory Validation Study Summary Report (Charles River/Argus) (PDF) (48pp, 311K)

Interlaboratory Validation Study Summary Report (Huntingdon) (PDF) (49pp, 1.9M)

Interlaboratory Validation Study Summary Report (WIL) (PDF) (59pp, 651K)

Interlaboratory Validation Study Analysis Report (Battelle) (PDF) (127pp, 13.5M)

Peer Review Results for the Pubertal Male Rat Assay (PDF) (80pp, 355K)

EPA Response to Peer Review Comments (PDF) (52pp, 188K)

Female Pubertal (Tier 1) (PDF file, 2pp, 88K)

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Detailed Review Paper equivalent (females). (Goldman JM et al. 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)

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)

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 Female Rats (XLS) (5pp, 179K)

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)

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)

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)

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)

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)

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)

Restricted feeding study (Laws SC et al. 2007. Effects of altered food intake during pubertal development in male and female Wistar rats. Toxicol Sci 100(1):194-202).

Integrated Summary Report (PDF) (122pp, 351K)

Interlaboratory Validation Study Summary Report (Charles River/Argus) (PDF) (38pp., 311KB)

Interlaboratory Validation Study Summary Report (Huntingdon) (PDF) (51pp, 1.9M)

Interlaboratory Validation Study Summary Report (WIL) (PDF) (53pp, 850K)

Interlaboratory Validation Study Analysis Report (Battelle) (PDF) (225pp, 7M)

Peer Review Results for the Female Pubertal Rat Assay (PDF) (106pp, 424K)

EPA Response to Peer Review Comments (PDF) (82pp, 287K)

Steroidogenesis - Sliced Testes (Tier 1) (PDF file, 2pp, 79K)

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Final Detailed Review Paper (PDF) (215pp, 1.2M)

Optimization of Assay Aug 2003 (PDF) (243pp, 6.1M)

Draft Prevalidation Plan Aug 2003 (PDF) (78pp, 450K)

Sliced Testis Assay Prevalidation: Multi-Chemical Study (PDF) (56pp, 237K)

Sliced Testis Assay Prevalidation: Multi-Laboratory Baseline/Positive Control Study (PDF) (98pp, 1.6M)

EDMVAC Consensus Recommendation on the Continued Development of the Sliced Testis Steroidogenesis Assay (PDF) (3pp, 166K)

EPA agrees with the EDMVAC recommendation (PDF) (1pp, 44 K)

 

Steroidogenesis - Cell-based H295R (Tier 1) (PDF file, 2pp, 88K)

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Final Detailed Review Paper (PDF) (217pp, 1.2M)

Presentation: Development and Pre-Validation of a H295R Cell Line Screening Test to Evaluate Toxicant-Induced Effects on Steroidogenesis (PDF) (58pp, 2.4M)

Peer Review Results for the Steroidogenesis H295R Assay (PDF) (77pp, 311K)

EPA Response to Peer Review Comments (PDF) (9pp, 47K)

Uterotrophic (Tier 1) (PDF) (2pp, 84K)

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Detailed Background Review of the Uterotrophic Bioassay (PDF) (217pp, 1.6M)

OECD Report of the Initial Work Towards the Validation of the Rodent Uterotrophic Bioassay: Phase 1 (PDF) (140pp, 622K)

OECD Draft Report of the Validation of the Rodent Uterotrophic Bioassay: Phase 2. Testing of Potent and Weak Oestrogen Agonists by Multiple Laboratories (PDF) (138pp, 939K)

Cover Letter Describing the Uterotrophic Peer Review Report Package (PDF) (2pp, 40K)

OECD Report of the Peer Review Panel for the Uterotrophic Bioassay (PDF) (12pp, 80K)

Responses from Peer Review Panel Members to Charge Questions (PDF) (51pp, 292K)

Proposal for the Uterotrophic Bioassay Validation Peer Review Process (PDF) (11pp, 63K)

Report of the Validation of the Uterotrophic Bioassay: Additional Data Supporting the Test Guideline on the Uterotrophic Bioassay In Rodents
(PDF)
(104pp, 1.3M)

OECD Guideline for the Testing of Chemicals: Uterotrophic Bioassay in Rodents: A Short-Term Screening Test for Oestrogenic Properties (PDF) (21pp, 257K)

15-Day Intact Adult Male Rat Assay (Tier 1) (PDF) (3pp, 93K)

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Reference List of Publications from the Lead Industrial Laboratories Developing the 15-Day Intact Adult Male Rat Assay (PDF) (1pp, 17K)

Development of an In Vivo Battery for Identifying Endocrine Modulators in Male Sprague Dawley Rats - Protocol, Generic Example (PDF) (9pp, 37K)

Reference Chemical Laboratory List for Developing the 15-Day Intact Adult Male Rat Assay (PDF) (1pp, 8K)

Summary Reports of Results from other Industry and Industry-Sponsored Contract Research Laboratories (PDF) (3pp, 24K)

Integrated Sumary Report (PDF) (223pp, 2.7M)

Final Report - Inter-Laboratory Validation (Charles River Laboratories) (PDF) (458pp, 17.3M)

Final Report - Inter-Laboratory Validation (RTI International) (PDF) (479pp, 16M)

Final Report - Inter-Laboratory Validation (WIL Research Laboratories, LLC) (PDF) (643pp, 15M)

Peer Review Results for the 15-Day Intact Adult Male Rat Assay (PDF) (101pp, 524K)

EPA Response to Peer Review Comments (PDF) (6pp, 33K)

Amphibian 2-Generation
(Tier 2)

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Detailed Review Paper (PDF) (137pp, 2M)

 

 

Avian 2-Generation
(Tier 2)

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Detailed Review Paper (PDF) (174pp, 905K)

 

Draft Study Plan Feb 2002 (PDF) (44pp, 526K)

Avian Comparison Report and Data (PDF) (41pp, 720K)

References with Abstracts (PDF) (8pp, 307K)

Avian Dosing Study by Battelle dated July 22, 2005 (PDF) (337pp, 2.2M)

EPA Analysis of the Avian Dosing Study dated October 31, 2005 (PDF) (34pp, 210K)

SAS Output for the Statistical Re-analysis on the Avian Dosing Study dated October 28, 2005 (PDF) (249pp, 1.1M)

OECD Guideline for Testing of Chemicals (proposal for a new test guideline for the avian 2-generation Toxicity testing in the Japanese Quail) dated November 2005 (PDF) (10pp, 77K)

Draft Final Report Appendices

  Appendix A: Candidate Test Substances (PDF) (2pp, 17K)

  Appendix B: Chemistry Report for ß Estradiol in Bird Feed (PDF) (37pp, 472K)

  Appendix C: Certified Purity of Carrier (Acetone) used in Test Diet Preparation (PDF) (1pp, 31K)

  Appendix D: Chemistry Report for 17 ß Estradiol Extraction and Measurement from Dosed Game Bird Feed (Avian Dosing Study) (PDF) (25pp, 637K)

  Appendix E: Assay for Endocrine-Active Agents in Basal Diet (PDF) (141pp, 3.1M)

  Appendix F: Egg Composites for Steroid Analysis (P1 and F1) (PDF) (17pp, 3.1M)

  Appendix G: Descriptive Statistics (PDF) (195pp, 2.7M)

  Appendix H: Power Statistics (PDF) (53pp, 530K)

  Appendix I: Genetic Sexing of Japanese Quail (Animal Genetics Inc.) (PDF) (10pp, 979K)

  Appendix J: Pathology Report for Avian Dosing Study (Experimental Pathology Laboratories, Inc.)

   J0. Text of Draft Pathology Report (PDF) (12pp, 36K)

   J1. Summary Incidence Tables P1 Generation Sacrifice (PDF) (21pp, 171K)

   J2. Summary Incidence Tables F1 Generation Sacrifice (PDF) (25pp, 197K)

   J3. Summary Incidence Tables F2 Generation Sacrifice (PDF) (23pp, 189K)

  Appendix K: Avian dosing Study Quality Assurance Project Plan and Revised Study Plan / Protocol (February 2003)

   K1. Quality Assurance Plan (PDF) (51pp, 2.9M)

   K2. Revised Study Plan (PDF) (48pp, 2.4M)

 

Fish Lifecycle (Tier 2)

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Detailed Review Paper (PDF) (133pp, 947K)

 

 

Invertebrate (Mysid) Lifecycle
(Tier 2)

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Draft Detailed Review Paper (PDF) (143pp, 2.1M)

   

Mammalian 2-Generation
(Tier 2)

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One Generation Extension Protocol (PDF) (40pp, 100K)

One Generation Extension Study Results (PDF) (69pp, 368K)

Selection of Dose Discussion Points (PDF) (3pp, 82K)

Two Generation Reproduction Toxicity Study of PTU (PDF) (130pp, 1.2M)

 

In Utero through Lactation
(Tier ?) (PDF)
(2pp, 84K)

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Detailed Review Paper (PDF) (159pp, 5.9M)

Study Plan Jan 2002 (PDF) (41pp, 480K)

 

 

Other Topics Related to the Assays

Preliminary Draft Under Development - EDSP and Other Validation Chemicals at a Glance (December 2005) (PDF) (35pp, 181K)

Draft Thyroid Detailed Review Paper (PDF) (283pp, 1.8M)

Update on Reference Chemicals (December 2003) (PDF) (3pp, 437K)

White Paper on Species/Strain/Stock in Endocrine Disruptor Assays (PDF) (97pp, 564K)

Reviewer’s Appendix to the White Paper on Species/Stock/Strain in Endocrine Disruptor Assays (PDF) (97pp, 546K)

Presentation: Pubertal Male and Female Rat Assay by Dr.Earl Gray (PDF) (109pp, 2M)

Update on Chemicals Used in EDMVS (August 2003)

Disclaimer and Questions for the EDMVS (August 2003) (PDF) (2pp, 56K)

ER Modality (August 2003) (PDF) (1pp, 39K)

AR Modality (August 2003) (PDF) (1pp, 39K)

Other Modalities (August 2003) (PDF) (2pp, 44K)

EPA's approach to Addressing Low Dose Issues (March 2002) (PDF) (1pp, 23K)

PLEASE NOTE:

Some of the documents presented may not be accessible using alternative access devices. If you need access to these documents please contact William Wooge at 202-564-8476. We will post accessible documents as soon as possible.

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