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EPA/630/R-96/012February 1997SPECIAL REPORT ONENVIRONMENTAL ENDOCRINE DISRUPTION:AN EFFECTS ASSESSMENTAND ANALYSISPrepared for theRisk Assessment ForumU.S. Environmental Protection AgencyWashington, D.C. 20460Technical PanelOffice of Research and DevelopmentThomas M. Crisp, Ph.D. (Chair)Eric D. Clegg, Ph.D.Ralph L. Cooper, Ph.D.Office of Prevention, Pesticides, and Toxic SubstancesDavid G. Anderson, Ph.D. Donald J. Rodier, M.S.Karl P. Baetcke, Ph.D. John E. Schaeffer, M.S.Jennifer L. Hoffmann, B.S. Leslie W. Touart, Ph.D.Melba S. Morrow, D.V.M. Maurice G. Zeeman, Ph.D.Office of WaterYogendra M. Patel, Ph.D.Risk Assessment Forum StaffWilliam P. Wood, Ph.D., Executive DirectorRisk Assessment ForumU.S. Environmental Protection AgencyWashington, D.C. 20460iiDISCLAIMERThis document has been reviewed in accordance with U.S. Environmental ProtectionAgency policy and approved for publication. Mention of trade names or commercial productsdoes not constitute endorsement or recommendation for use.iiiCONTENTSLIST OF ACRONYMS/ABBREVIATIONS.................................................................... viPREFACE ................................................................viiI. EXECUTIVE SUMMARY ..................................................1A. PURPOSE OF DOCUMENT AND AREAS CONSIDERED ...................1B. GENERAL BACKGROUND ...........................................21. Nature of Hormones .................................................22. Role of the Endocrine System ..........................................2C. TECHNICAL PANEL’S MAJOR FINDINGS ..............................21. Human Health Effects ................................................2a. Types of Effects .................................................2i. Female Reproductive System .....................................2ii. Male Reproductive System ......................................3iii. Hypothalamus and Pituitary .....................................4iv. Thyroid .....................................................5b. Strengths and Weaknesses of the Data ................................5c. Conclusions ....................................................62. Ecological Effects ...................................................6a. Types of Studies ................................................6b. Strengths and Weaknesses of the Data ...............................8c. Conclusions ....................................................8d. Agency Actions .................................................93. Further Research ...................................................10II. INTRODUCTION .......................................................11A. GENERAL BACKGROUND ..........................................11B. HORMONES ......................................................13C. ENDOCRINE/HORMONE DISRUPTORS ...............................131. Altered Hormone Synthesis ...........................................142. Altered Hormone Storage and/or Release ................................153. Altered Hormone Transport and Clearance ...............................154. Altered Hormone Receptor Recognition/Binding ...........................165. Altered Hormone Postreceptor Activation ................................17D. RISK ASSESSMENT PARADIGM .....................................17E. CONTROVERSY WITHIN THE SCIENTIFIC COMMUNITY ................19III. SPECIFIC ENDPOINTS OF CONCERN .....................................21A. HUMAN HEALTH EFFECTS .........................................211. Female Reproductive and Developmental Effects ..........................21a. Ovary and Reproductive Tract .....................................21ivI. Background .................................................22ii. Toxicity Testing in Animals and Extrapolation to Humans ..............25iii. Conclusions ................................................27b. Endometriosis ..............................................28i. Background .................................................28ii. Toxicity Testing in Animals and Extrapolation to Humans ..............29iii. Conclusions ................................................29c. Breast Cancer .................................................29i. Background .................................................29ii. Toxicity Testing in Animals and Extrapolation to Humans ..............31iii. Conclusions ................................................322. Male Reproductive System Effects .....................................33a. Background ...................................................33b. Influence of Hormones on the Mammalian Male Reproductive System .......35i. Antiandrogens ...............................................35ii. Estrogens ..................................................36iii. Ah receptor agonists ..........................................38c. Testicular Cancer ...............................................39i. Germ Cell Tumors ............................................39ii. Leydig Cell Hyperplasia and Tumors ..............................40d. Conclusions ...................................................41e. Prostate Cancer ................................................42i. Background .................................................42ii. Toxicity Testing in Animals and Extrapolation to Humans ..............43iii. Conclusions ................................................443. Hypothalamus and Pituitary ...........................................44a. Mammalian Development .........................................44b. Multiple Control of Pituitary Hormones ..............................464. Thyroid Effects ....................................................48a. Background ...................................................485. Endocrine Disruptors and Immunotoxicology .............................52B. EFFECTS ON AQUATIC LIFE AND WILDLIFE ..........................541. Background ......................................................54a. Synthetic Chemicals (Xenobiotics) ..................................54b. Phytoestrogens ................................................552. Endocrine-Related Effects ............................................553. Representative Examples .............................................56a. Invertebrates ..................................................56b. Fish .........................................................59c. Amphibians


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