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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).

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 file, 3pp, 124K)

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

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

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

OECD Detailed Review Paper (PDF file, 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 file, 83pp, 2.8M)

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

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

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

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

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

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

Androgen Receptor (AR) Binding (Tier 1) (PDF file, 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 file, 6pp, 22K)

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

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

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

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

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

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

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

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

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

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

Human Placental and Recombinant Data:

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

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

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

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

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

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

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

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

Estrogen Receptor (ER) Binding (Tier 1) (PDF file, 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 file, 7pp,22K)

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

 

 

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

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

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

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

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

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

Draft Final Report on Comparative Evaluation of the Fathead Minnow:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hershberger (Tier 1) (PDF file, 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) (209 pp, 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) (110 pp, 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) (145 pp, 1.8M)

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

Male Pubertal (Tier 1) (PDF file, 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) (80 pp, 355K)

EPA Response to Peer Review Comment (PDF) (52 pp, 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).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

 

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

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

OECD Report of the Initial Work Towards the Validation of the Rodent Uterotrophic Bioassay: Phase 1 (PDF file, 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 file, 138pp, 939K)

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

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

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

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

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

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

15-Day Intact Adult Male Rat Assay (Tier 1) (PDF file, 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 file, 1pp, 17K)

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

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

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

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

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

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

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

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

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

Amphibian 2-Generation
(Tier 2)

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

 

 

Avian 2-Generation
(Tier 2)

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

 

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

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

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

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

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

SAS Output for the Statistical Re-analysis on the Avian Dosing Study dated October 28, 2005 (PDF file, 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 file, 10pp, 77K)

Draft Final Report Appendices

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

Fish Lifecycle (Tier 2)

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

 

 

Invertebrate (Mysid) Lifecycle
(Tier 2)

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

   

Mammalian 2-Generation
(Tier 2)

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

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

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

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

 

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

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

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

 

 

Other Topics Related to the Assays

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

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

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

White Paper on Species/Strain/Stock in Endocrine Disruptor Assays (PDF file, 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 file, 109pp, 2M)

Update on Chemicals Used in EDMVS (August 2003)

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

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

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

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

EPA's approach to Addressing Low Dose Issues (March 2002) (PDF file, 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.

Documents presented on this page may be in Microsoft PowerPoint (PPT), Microsoft Excel (XLS), or Lotus Freelance Format (PRZ). To view or print them you will need to have their associated programs installed on your computer. The programs can be downloaded and used with no charge from the following links.


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