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Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC)

November 30 - December 2, 2005 Meeting

Agenda

PDF File [3 pp., 48KB, About PDF] HTML File [18KB]

Federal Register Notices Announcing Meeting | Copy for Public Comment

Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting [PDF file, 3 pp., 81KB, About PDF]

Background Documents and Corresponding Presentation(s)

EDMVAC Workplan [PDF file, 23 pp., 161KB, About PDF]

EDSP's Applied Approach to Validation

Validation Paper [PDF file, 14pp., 81KB, About PDF]

Presentation: EDSP's Applied Approach to Validation [PDF file, 34 pp., 39KB, About PDF]

Steroidogenesis Assay Using H295R Cell Line

Updated Steroidogenesis Short Story [PDF file, 5 pp.,123KB, About PDF]

Presentation: Development and Pre-Validation of a H295R Cell Line Screening Test to Evaluate Toxicant-Induced Effects on Steroidogenesis [PDF file, 51 pp., 2.4MB, About PDF]

Avian Species Comparison Study

Avian Comparison Report and Data [PDF file, 41 pp., 720KB, About PDF]

References with Abstracts [PDF file, 8 pp., 307KB, About PDF]

Presentation: A Protocol Development Study for the Avian 2-Generation Tier II Assay [PDF file, 37 pp., 894KB, About PDF]

Avian Dosing Study

Avian Dosing Study by Battelle dated July 22, 2005 [PDF file, 337 pp., 2.2MB, About PDF]

Presentation: Avian Dosing Study [PDF file, 45 pp., 180KB, About PDF]

EPA Analysis of the Avian Dosing Study dated October 31, 2005 [PDF file, 34 pp., 210KB, About PDF]

SAS Output for the Statistical Re-analysis on the Avian Dosing Study dated October 28, 2005 [PDF file, 249 pp., 1.1MB, About PDF]

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, 10 pp., 77KB, About PDF]

Draft Final Report Appendices

Appendix A: Candidate Test Substances [PDF file, 2 pp., 17KB, About PDF]

Appendix B: Chemistry Report for ß Estradiol in Bird Feed [PDF file, 37 pp., 472KB, About PDF]

Appendix C: Certified Purity of Carrier (Acetone) used in Test Diet Preparation [PDF file, 1 pp., 31KB, About PDF]

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

Appendix E: Assay for Endocrine-Active Agents in Basal Diet [PDF file, 141 pp., 3.1MB, About PDF]

Appendix F: Egg Composites for Steroid Analysis (P1 and F1) [PDF file, 17 pp., 3.1MB, About PDF]

Appendix G: Descriptive Statistics [PDF file, 195 pp., 2.7MB, About PDF]

Appendix H: Power Statistics [PDF file, 53 pp., 530KB, About PDF]

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

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

  J0. Text of Draft Pathology Report [PDF file, 12 pp., 36KB, About PDF]

  J1. Summary Incidence Tables P1 Generation Sacrifice [PDF file, 21 pp., 171KB, About PDF]

  J2. Summary Incidence Tables F1 Generation Sacrifice [PDF file, 25 pp., 197KB, About PDF]

  J3. Summary Incidence Tables F2 Generation Sacrifice [PDF file, 23 pp., 189KB, About PDF]

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

  K1. Quality Assurance Plan [PDF file, 51 pp., 2.9MB, About PDF]

  K2. Revised Study Plan [PDF file, 48 pp., 2.4MB, About PDF]

Questions for EDMVAC Response and Discussion [PDF file, 1 pp., 11KB, About PDF]

Pubertals

Pubertals Short Story [PDF file, 2 pp., 21KB, About PDF]

Presentation: Status of the Male and Female Pubertal Assay [PDF file, 14 pp., 124KB, About PDF]

Uterotrophic (Tier 1, OECD) Assay

Cover Letter Describing the Uterotrophic Peer Review Report Package [PDF file, 2 pp., 40KB, About PDF]

OECD Report of the Peer Review Panel for the Uterotrophic Bioassay [PDF file, 12 pp., 80KB, About PDF]

Responses from Peer Review Panel Members to Charge Questions [PDF file, 51 pp., 292KB, About PDF]

Proposal for the Uterotrophic Bioassay Validation Peer Review Process [PDF file, 11 pp., 63KB, About PDF]

Presentation: The Uterotrophic Bioassay Peer Review [PDF file, 15 pp., 45KB, About PDF]

Presentation: Uterotrophic Assay Post Peer Review Options [PDF file, 3 pp., 12KB, About PDF]

Preliminary Draft Under Development - EDSP and Other Validation Chemicals at a Glance [PDF file, 35 pp., 181

Public Comments

Comments by Dr. Ellen Mihaich on behalf of the American Chemistry Council [PDF file, 7 pp., 198KB, About PDF]

Comments by Dr. Abraham Tobia, Toxicology Fellow Bayer CropScience [PDF file, 6 pp., 134KB, About PDF]

Comments by Sue Marty on behalf of Richard Becker of the American Chemistry Council [PDF file, 6 pp., 197KB, About PDF]

EDMVAC Recommendations

Meeting Summary


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