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Guidelines for Reproductive Toxicity Risk Assessment

By Environmental Protection Agency

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Book Id: WPLBN0000126500
Format Type: PDF eBook
File Size: 0.4 MB
Reproduction Date: 2007
Full Text

Title: Guidelines for Reproductive Toxicity Risk Assessment  
Author: Environmental Protection Agency
Volume:
Language: English
Subject: Ecology, Natural resource issues, Environemtal protection
Collections: Environmental Awareness Library Collection
Historic
Publication Date:
Publisher: United States Environmental Protection Agency

Citation

APA MLA Chicago

Agency, E. P. (n.d.). Guidelines for Reproductive Toxicity Risk Assessment. Retrieved from http://worldebookfair.com/


Description
Excerpt: This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.

Table of Contents
CONTENTS List of Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Federal Register Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Part A: Guidelines for Reproductive Toxicity Risk Assessment 1. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. Definitions and Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3. Hazard Characterization for Reproductive Toxicants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3.1. Laboratory Testing Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.1.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.1.2. Duration of Dosing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.1.3. Length of Mating Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3.1.4. Number of Females Mated to Each Male . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3.1.5. Single- and Multigeneration Reproduction Tests . . . . . . . . . . . . . . . . . . . . . . . . . . 8 3.1.6. Alternative Reproductive Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.1.7. Additional Test Protocols That May Provide Reproductive Data . . . . . . . . . . . . . 12 3.2. Endpoints for Evaluating Male and Female Reproductive Toxicity in Test Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 3.2.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 3.2.2. Couple-Mediated Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3.2.2.1. Fertility and Pregnancy Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3.2.2.2. Sexual Behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3.2.3. Male-Specific Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 3.2.3.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 3.2.3.2. Body Weight and Organ Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 3.2.3.3. Histopathologic Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.2.3.4. Sperm Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3.2.3.5. Paternally Mediated Effects on Offspring . . . . . . . . . . . . . . . . . . . . . . . 33 3.2.4. Female-Specific Endpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 3.2.4.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 3.2.4.2. Body Weight, Organ Weight, Organ Morphology, and Histology . . . . . 35 3.2.4.3. Oocyte Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 3.2.4.4. Alterations in the Female Reproductive Cycle . . . . . . . . . . . . . . . . . . . 42 3.2.4.5. Mammary Gland and Lactation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 3.2.4.6. Reproductive Senescence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 3.2.5. Developmental and Pubertal Alterations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 3.2.5.1. Developmental Effects . . . . . . . . . . . . . . . . . . . . . . . .

 

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