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

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736 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITIONTable 19.3List of useful research organizationsReproductive and Developmental ToxicologyTeratology SocietyMiddle Atlantic Reproduction andTeratology Association (MARTA)Midwest Teratology Association(MTA)Society of Toxicology Reproductiveand Developmental SpecialtySectionAustralian Teratology Society (ATS)European Teratology Society (ETS)Japanese Teratology Societyhttp://www.teratology.org/http://www.teratology.org/members/MARTAtext.htmhttp://www.midwest-teratology.org/http://www.toxicology.org/memberservices/specsection/specsection.htmlhttp://www.cchs.usyd.edu.au/bio/ats/atshome.htmhttp://www.etsoc.com/http://www.med.hiroshima-u.ac.jp/med/med/kiso/kaibo1/CongAnom/eWelcome.htmlToxicologySociety of Toxicology (SOT)American College of Toxicology(ACT)Mid-Atlantic Chapter of Society ofToxicology (MASOT)Italian Society of ToxicologyBritish Toxicology SocietyEurotoxAmerican Board of Toxicology (ABT)Academy of Toxicological Sciences(ATS)Society of Toxicology of Canadahttp://www.toxicology.org/http://www.landaus.com/toxicology/http://www.masot.org/http://users.unimi.it/~spharm/sit/engSIThome.htmlhttp://www.thebts.org/http://www.eurotox.com/http://www.abtox.org/http://www.acadtox.com/http://meds.queensu.ca/stcweb/index.htmlNeurotoxicologyNeurobehavioral Teratology Society(NBTS)Behavioral Toxicology SocietyThe Society for Neuroscience (SFN)The International NeurotoxicologyAssociationhttp://nbts.bsbe.umn.edu/http://www.behavioraltoxicology.org/BTS.htmlhttp://www.sfn.orghttp://www.neurotoxicology.org/Additional ResourcesReproductive Toxicology($850/year online)International Federation ofTeratology Societies (IFTS) Atlasof Developmental AbnormalitiesNational Institute of EnvironmentalHealth Sciences (NIEHS)Teratogen Information System(TERIS, $1000/year)http://www.elsevier.nl/locate/reprotoxhttp://www.ifts-atlas.org/http://www.niehs.nih.gov/http://depts.washington.edu/~terisweb/Recently, new guidelines have been developed to address specific political and economicconcerns, particularly regarding potential hazards to children. These guidelines are related toconcerns regarding treatment of neonatal and pediatric patients with pharmaceuticals and chronicand inadvertent exposure to food additives and other environmental chemicals, particularly late ingestation and/or before puberty, as described in the following information.The current FDA and ICH guidelines 2 for pharmaceuticals include postnatal evaluations inanimals for behavioral and functional alterations, in particular those concerning potential exposure© 2006 by Taylor & Francis Group, LLC
PERSPECTIVES ON THE DEVELOPMENTAL AND REPRODUCTIVE TOXICITY GUIDELINES 737of the central nervous system and other systems that continue to develop postnatally (e.g., pulmonary,immune, renal, osseous, and gastrointestinal) and thus may be potentially affected during lategestation and the early neonatal period. The FDA currently has a pediatric study requirement (1998Final Rule: Pediatric Studies). 37 To conform with this requirement, all new drugs, generally prescriptiondrugs (including biologics or drugs derived from living organisms), that are intended forcommon use in children or are important in medical treatment of children must include labelinginformation on safe pediatric use. Similar efforts are ongoing in the EU. 15More extensive increases in requirements for pediatric testing have been enacted or are underconsideration by the EPA and the OECD. In 1997, the EPA issued entirely new guidelines inresponse to children’s health concerns and established the Office of Children’s Health Protection(OCHP). 38 This federal agency identified four major environmental threats to children: (1) leadpoisoning; (2) pesticides in household chemicals and food, (3) asthma, and (4) drinking watercontaminants (principally microbial), polluted water, toxic waste dumps, PCBs, second-handtobacco smoke, UV light, and endocrine disruptors, and potential effects from particulate matterair pollution. These relatively new EPA guidelines are based on the perceived greater relativevulnerability of children to environmental threats. This perception is based on children havingimmature body organs and tissues, rapidly changing as they develop from infants to adolescents.They have weaker immune systems during infancy and are potentially exposed to more environmentalthreats while being least able to protect themselves from such hazards. One response tothese concerns was the issue of the EPA guidelines for developmental neurotoxicity. 24Another important response of the EPA is its endocrine disruption program, which was mandatedby the Food Quality Protection Act 39 and authorized by the amended Safe Water Act. 40 These twoacts resulted in formation of the Endocrine Disruptor Screening and Testing Advisory Committee(EDSTAC), which has completed its mandate. EDSTAC’s purpose was to develop recommendationsfor an endocrine disruptor screening program. 41 One of EDSTAC’s recommendations was expansionof the endocrine disruptor screening program to include not only pesticides but also chemicalsregulated under the TSCA, nutritional supplements, food additives, and cosmetics. EDSTAC alsorecommended that screens be performed to evaluate endocrine-mediated effects on the androgenand thyroid systems and other effects on fish and wildlife. 42,43The EDSTAC recommendations were used to design the EPA Endocrine Disruptor ScreeningProgram (EDSP). The Endocrine Disruptor Method Validation Subcommittee (EDMVS), which isunder a Federal Advisory Committee — the National Advisory Council for Environmental Policyand Technology (NACEPT) 44 — is one essential part of implementation of the EDSP. The EDMVSis responsible for evaluating the methods and the results of validation efforts for the new protocolsrecommended by EDSTAC. New protocols currently being considered for validation or in thevalidation process include a one-generation extension study 45 and a 20-day pubertal developmentand thyroid function study in juvenile male and female rats. 46,47Internationally, an OECD Task Force on Endocrine Disruptor Testing and Assessment (EDTA)was instituted in December, 1997 in an effort to: (1) consider and recommend priorities for thedevelopment of methods to detect estrogenic and androgenic effects and (2) harmonize test methodsand assessments of endocrine disruptors. Under the direction of the EDTA, OECD ValidationManagement groups were established to manage the technical conduct of validation work forscreening and testing for endocrine-mediated mammalian and ecotoxicological effects. The validationtesting phase has been completed for the rodent uterotrophic assay. 48 Revisions of the OECDTwo Generation Reproductive Toxicity 29 and Teratogenicity 27 guidelines have been issued as OECDTest Guidelines 416 and 414, respectively. Additional projects currently being addressed by theOECD include validation of the rodent Hershberger assay 48 and of studies to assess the feasibilityof enhancing the current OECD TG 407 (Repeated Dose Toxicity) guideline. 49 The EPA and OECDare working in close cooperation regarding the validation programs.© 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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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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Table 6.10DescriptionMuscular Syste
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Distalphalanges offingersseparatedF
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Table 6.11DescriptionIntermediateme
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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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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 9.48What 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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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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PERSPECTIVES ON THE DEVELOPMENTAL A
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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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There are six factors that may affe
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