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

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248 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITIONFRONT Centrum BACKTransverseprocessVertebralarchFRONTSpinous processSacralIIIIlliumIIIOssified areas are open, cartilage is shaded.Thoracic centraCaudal centraFigure 7.11Enlarged views of selected elements of the axial skeleton of a term (GD 20) rat fetus.manifested as lack of ossification of sternebrae (V, VI, and/or II in rats, VI in mice) and as bipartiteor dumbbell-shaped cartilage or unossified centra (in rats). There is less variability in the developmentof the skeleton if the sacrifice day is GD 21 for rats and GD 18 for mice, but the risk ofdelivery prior to scheduled sacrifice is increased.During the fetal examinations, all unusual (notable) observations are recorded or described bythe examining technician. This is done for each individual fetus on the appropriate data collectionsheet or in the appropriate locations on the computer terminal display. The observations willsubsequently be coded as malformations (M) or variations (V) by a designated staff member (withinput from the study director, laboratory supervisor, veterinarian, pathologist, etc., as appropriate),based on previously established criteria and designations (usually defined by the study director andlaboratory supervisor). The determination of M or V status for each observation is made in thecontext of three salient factors:• In the test animal and human literature on malformations, there is no case to date where ateratogenic agent causes a new, “never before seen” malformation. What is detected is an increasein the incidence of the malformation(s) above those seen in the general population. The current© 2006 by Taylor & Francis Group, LLC
DEVELOPMENTAL TOXICITY TESTING — METHODOLOGY 249Figure 7.12Detailed view of ribs from a term (GD 20) rat fetus.Figure 7.13Detailed view of forepaw and hindpaw skeletal elements from a term (GD 20) rat fetus.view is that teratogenic agents act on susceptible genetic loci or on susceptible developmentalevents. Therefore, the response seen is influenced by the genetic background and will vary byspecies, strain, race (in the case of humans), and individual (the last is more relevant to outbredstrains and/or to genetically heterogeneous populations than to inbred strains).• There is genetic predisposition to certain malformations that characterizes specific species, strains,races, and individuals. Historical control data are indispensable (along with concurrent controls)for determining the designation and occurrence of the present finding(s) in the context of the© 2006 by Taylor & Francis Group, LLC
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Second EditionDEVELOPMENTALandREPRO
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Published in 2006 byCRC PressTaylor
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Chapter 12Chapter 13Chapter 14Chapt
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The EditorRonald D. Hood, Ph.D., is
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Alan M. HobermanArgus ResearchHorsh
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APPENDIX ATerminology of Anatomical
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TERMINOLOGY OF ANATOMICAL DEFECTS 9
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Organ/StructureCodeNumberObservatio
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Organ/Structure10145 Ocular colobom
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Organ/StructurePulmonaryarteryPulmo
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Terminology of developmental abnorm
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Organ/StructureCervicalcentrumCodeN
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Organ/Structure10689 Misshapen thor
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Organ/StructureSacralcentrumSacralv
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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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Page 423 and 424: COMPARATIVE FEATURES OF VERTEBRATE
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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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CHAPTER 21Developmental and Reprodu
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