A Practical Approach, Second Edition=Ronald D. Ho.pdf

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Published in 2006 byCRC PressTaylor & Francis Group6000 Broken Sound Parkway NW, Suite 300Boca Raton, FL 33487-2742© 2006 by Taylor & Francis Group, LLCCRC Press is an imprint of Taylor & Francis GroupNo claim to original U.S. Government worksPrinted in the United States of America on acid-free paper10 9 8765 4321International Standard Book Number-10: 0-8493-1254-X (Hardcover)International Standard Book Number-13: 978-0-8493-1254-0 (Hardcover)Library of Congress Card Number 2005043988This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted withpermission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publishreliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materialsor for the consequences of their use.No part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, orother means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any informationstorage or retrieval system, without written permission from the publishers.For permission to photocopy or use material electronically from this work, please access www.copyright.com(http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC) 222 Rosewood Drive, Danvers, MA01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. Fororganizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged.Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only foridentification and explanation without intent to infringe.Library of Congress Cataloging-in-Publication DataDevelopmental and reproductive toxicology : a practical approach / edited by Ronald D. Hood. -- 2nd ed.p. cm.First ed. published in 1997 under title: Handbook of developmental toxicology.ISBN 0-8493-1254-X1. Developmental toxicology--Handbooks, manuals, etc. 2. Reproductive toxicology--Handbooks,manuals, etc. I. Hood, Ronald D. II. Handbook of developmental toxicology.RA1224.2.H36 2005615.9--dc22 2005043988Taylor & Francis Groupis the Academic Division of T&F Informa plc.Visit the Taylor & Francis Web site athttp://www.taylorandfrancis.comand the CRC Press Web site athttp://www.crcpress.com© 2006 by Taylor & Francis Group, LLC
CONTENTSPART IPRINCIPLES AND MECHANISMS .............................................................................................1Chapter 1 Principles of Developmental Toxicology Revisited ..................................................3Ronald D. HoodChapter 2Chapter 3Chapter 4Chapter 5Experimental Approaches to Evaluate Mechanisms of DevelopmentalToxicity.....................................................................................................................15Elaine M. Faustman, Julia M. Gohlke, Rafael A. Ponce,Thomas A. Lewandowski, Marguerite R. Seeley, Stephen G. Whittaker,and William C. GriffithPathogenesis of Abnormal Development.................................................................61Lynda B. Fawcett and Robert L. BrentMaternally Mediated Effects on Development........................................................93Ronald D. Hood and Diane B. MillerPaternally Mediated Effects on Development.......................................................125Barbara F. Hales and Bernard RobaireChapter 6 Comparative Features of Vertebrate Embryology .................................................147John M. DeSessoPART IIHAZARD AND RISK ASSESSMENT AND REGULATORY GUIDANCE........................199Chapter 7 Developmental Toxicity Testing — Methodology ................................................201Rochelle W. Tyl and Melissa C. MarrChapter 8 Nonclinical Juvenile Toxicity Testing ...................................................................263Melissa J. Beck, Eric L. Padgett, Christopher J. Bowman,Daniel T. Wilson, Lewis E. Kaufman, Bennett J. Varsho,Donald G. Stump, Mark D. Nemec, and Joseph F. HolsonChapter 9Significance, Reliability, and Interpretation of Developmental andReproductive Toxicity Study Findings .................................................................329Joseph F. Holson, Mark D. Nemec, Donald G. Stump, Lewis E. Kaufman,Pia Lindström, and Bennett J. VarshoChapter 10 Testing for Reproductive Toxicity .........................................................................425Robert M. ParkerChapter 11The U.S. EPA Endocrine Disruptor Screening Program: In Vitro and In VivoMammalian Tier I Screening Assays.....................................................................489Susan C. Laws, Tammy E. Stoker, Jerome M. Goldman, Vickie Wilson,L. Earl Gray, Jr., and Ralph L. Cooper© 2006 by Taylor & Francis Group, LLC
Page 2 and 3: Second EditionDEVELOPMENTALandREPRO
Page 6 and 7: Chapter 12Chapter 13Chapter 14Chapt
Page 8 and 9: The EditorRonald D. Hood, Ph.D., is
Page 10 and 11: Alan M. HobermanArgus ResearchHorsh
Page 12 and 13: APPENDIX ATerminology of Anatomical
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Organ/StructureCervicalcentrumCodeN
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Organ/Structure10689 Misshapen thor
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TERMINOLOGY OF ANATOMICAL DEFECTS 9
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968 DEVELOPMENTAL REPRODUCTIVE TOXI
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1000 DEVELOPMENTAL REPRODUCTIVE TOX
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Table 1Human Non-human Primate Rat
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Table 1 (continued)Sertoli CellsHum
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Table 2 (continued) Landmarks in th
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Table 2 (continued) Landmarks in th
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POSTNATAL DEVELOPMENTAL MILESTONES
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PART IPrinciples and Mechanisms© 2
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4 DEVELOPMENTAL REPRODUCTIVE TOXICO
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10 DEVELOPMENTAL REPRODUCTIVE TOXIC
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Table 2.6Receptor(Official Name a )
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Clearly, more research needs to be
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CHAPTER 6Comparative Features of Ve
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COMPARATIVE FEATURES OF VERTEBRATE
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Table 6.2Comparative reproductive a
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Maturation andRelease ofGametesSper
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Amniotic cavity 9.5 1.5 1-4 1-4,6,9
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Posteriorcardinal veinsestablishedT
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PosteriorcardinaldegenerationRight
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StomachappearsThirdpharyngealpouch;
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Table 6.6DescriptionComparative ges
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ParathyroidParathyroids 12.5 6.2 41
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Table 6.8DescriptionComparative ges
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Formation ofchoroid plexusof latera
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Optic nervefibers presentDifferenti
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Table 6.10DescriptionMuscular Syste
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Distalphalanges offingersseparatedF
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Table 6.11DescriptionIntermediateme
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Table 6.12DescriptionComparative ge
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CHAPTER 7Developmental Toxicity Tes
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DEVELOPMENTAL TOXICITY TESTING —
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Female 0.00-0.69 0.004-0.39 0.00-0.
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Figure 8.11775Pott DescribesScrotal
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The underlying physiology of juveni
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Table 8.5Total body composition by
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Table 8.6Serum chemistry values for
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Table 8.7Parameter bHematology valu
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CHAPTER 9Significance, Reliability,
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DEVELOPMENTAL AND REPRODUCTIVE TOXI
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Prior to the early 1980s, numerous
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Figure 9.51906Food andDrugs Act2000
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Table 9.18Selected comparison point
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Table 9.33Selected comparison point
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Table 9.48What do regulatorswant to
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CHAPTER 10Testing for Reproductive
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TESTING FOR REPRODUCTIVE TOXICITY 4
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We would like to acknowledge the ef
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CHAPTER 12Role of Xenobiotic Metabo
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ROLE OF XENOBIOTIC METABOLISM IN DE
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y ESR spectrometry. 122 Further ESR
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CHAPTER 13Use of Toxicokinetics in
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USE OF TOXICOKINETICS IN DEVELOPMEN
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CHAPTER 17Statistical Analysis for
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STATISTICAL ANALYSIS FOR DEVELOPMEN
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CHAPTER 19Perspectives on the Devel
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PERSPECTIVES ON THE DEVELOPMENTAL A
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Guideline OECD 415 (One Generation)
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The Office of Prevention, Pesticide
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CHAPTER 20Human Studies — Epidemi
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HUMAN STUDIES 801I. INTRODUCTIONEpi
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HUMAN STUDIES 803is actively trying
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HUMAN STUDIES 80940003500Mean birth
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HUMAN STUDIES 811from monstrous, us
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CHAPTER 21Developmental and Reprodu
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There are six factors that may affe
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