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

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Chapter 12Chapter 13Chapter 14Chapter 15Chapter 16Role of Xenobiotic Metabolism in Developmental and Reproductive Toxicity.......525Arun P. KulkarniUse of Toxicokinetics in Developmental and Reproductive Toxicology..............571Patrick J. WierCellular, Biochemical, and Molecular Techniques in DevelopmentalToxicology..............................................................................................................599Barbara D. Abbott, Mitchell B. Rosen, and Gary HeldFunctional Genomics and Proteomics in Developmental andReproductive Toxicology .......................................................................................621Ofer Spiegelstein, Robert M. Cabrera, and Richard H. FinnellIn Vitro Methods for the Study of Mechanisms of DevelopmentalToxicology..............................................................................................................647Craig Harris and Jason M. HansenChapter 17 Statistical Analysis for Developmental and Reproductive Toxicologists .............697James J. ChenChapter 18Chapter 19Chapter 20Chapter 21Quality Concerns for Developmental and Reproductive Toxicologists................713Kathleen D. Barrowclough and Kathleen L. ReedPerspectives on the Developmental and Reproductive Toxicity Guidelines.........733Mildred S. Christian, Alan M. Hoberman, and Elise M. LewisHuman Studies — Epidemiologic Techniques in Developmental andReproductive Toxicology .......................................................................................799Bengt KällénDevelopmental and Reproductive Toxicity Risk Assessmentfor Environmental Agents......................................................................................841Carole A. Kimmel, Gary L. Kimmel, and Susan Y. EulingChapter 22 Principles of Risk Assessment — FDA Perspective .............................................877Thomas F. X. Collins, Robert L. Sprando, Mary E. Shackelford,Marion F. Gruber, and David E. MorseAppendix A Terminology of Anatomical Defects.....................................................................911Appendix B Books Related to Developmental and Reproductive Toxicology.........................967Appendix C Postnatal Developmental Milestones ....................................................................969© 2006 by Taylor & Francis Group, LLC
PrefaceThe areas of developmental and reproductive toxicology are becoming increasingly important.Developmental toxicology encompasses the study of hazard and risk associated with exposure totoxicants during prenatal development and has been expanded in recent years to include effects onthe developmental process until the time of puberty, i.e., until the completion of all developmentalprocesses. It is well known that a considerable percentage of newborns have significant anatomicaldefects, that birth defects are a major cause of hospitalization of infants, that “spontaneous” abortionand perinatal death are common, and that numerous individuals suffer from congenital functionaldeficits such as mental retardation. Although considerable progress has been made in determiningthe cause of these defects, the etiology of the majority of birth defects is not yet known or onlypoorly established. We still must learn much about the mechanisms involved in eliciting congenitaldefects and the genetic and environmental factors and their interactions that trigger these mechanisms.Reproductive toxicology is the study of adverse effects of chemical or physical agents onthe reproductive processes of both sexes and the causes of such effects. Concern has been voicedregarding reproductive issues, such as the possibility that human sperm counts have decreased inat least some geographic areas in recent times and that early menarche and precocious breastdevelopment may have environmental causes. Thus it is certain that both mechanistic studies ofknown developmental and reproductive toxicants and the toxicological assessment of pharmaceuticalagents, food additives, pesticides, industrial chemicals, environmental pollutants, and the liketo which humans may be exposed will be of importance for the foreseeable future. This situationpoints to the need for useful references in the field of developmental toxicology, teratology, andreproductive toxicology, and provides the impetus for the current volume.The purpose of this book is to provide a practical guide to the practice of developmental andreproductive toxicology; inclusion in a single volume of material from these areas will be of valueto the many individuals with professional responsibilities in both. Further, this book providesinformation in one source that is currently scattered through the literature or has not been readilyavailable; it provides much of that information in considerable detail. Although the current workis primarily oriented toward research designed to establish the likelihood of harm to humans, itshould also prove useful to those who are primarily interested in effects on other organisms. Thisbook should be especially useful for individuals working in industry who are responsible for testingchemical agents for developmental or reproductive toxicity and for those who manage such endeavors.It should be helpful to regulatory scientists at all levels of government who must evaluate theadequacy of studies and who must interpret data on hazard and establish the potential risk fromexposures. This volume will also be useful in training students and technicians, and for individualsactive in other areas who find the need to become familiar with the principles and practice ofdevelopmental or reproductive toxicology.Developmental and Reproductive Toxicology: A Practical Approach is intended to be a practicalguide as well as informative, providing insights gained from hands-on experience along with atheoretical foundation. Although this book is intended to be a relatively comprehensive guide tothe fields of developmental and reproductive toxicology, there were practical limits to the numberand scope of areas that it could address. It should also be noted that mention of vendors, tradenames, or commercial products does not constitute an endorsement or recommendation for use.The editor wishes to especially thank the contributing authors, whose efforts and expertise madethis project a success. Thanks also go to Taylor & Francis and the following individuals in itsemploy: Stephen Zollo, who proposed that the current work be published as a follow-up to theHandbook of Developmental Toxicology, which I had previously edited, and who has providedinvaluable advice and encouragement on the project, and to Patricia Roberson, who has providedessential technical guidance during the process of bringing the book to publication.© 2006 by Taylor & Francis Group, LLC
Page 2 and 3: Second EditionDEVELOPMENTALandREPRO
Page 4 and 5: Published in 2006 byCRC PressTaylor
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/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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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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CHAPTER 21Developmental and Reprodu
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