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:
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.
Assay Title
|
Assay
Development
|
Pre-Validation
|
Validation and Peer Review
|
Amphibian Metamorphosis (Tier 1) (PDF file, 3pp, 124K)
Top of page
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
|
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
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)
Top of page
|
Detailed Review Paper (PDF file, 137pp, 2M) |
|
|
Avian 2-Generation
(Tier 2)
Top of page
|
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)
Top of page |
Detailed
Review Paper (PDF file, 133pp, 947K)
|
|
|
Invertebrate (Mysid) Lifecycle
(Tier 2)
Top of page |
Draft Detailed Review Paper (PDF file, 143pp, 2.1M)
|
|
|
Mammalian 2-Generation
(Tier 2)
Top of page
|
|
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)
Top of page
|
Detailed
Review Paper (PDF file, 159pp, 5.9M)
|
Study
Plan Jan 2002 (PDF file, 41pp, 480K)
|
|