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872 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITION101. Lau, C., Mole, M.L., Copeland, M.F., Rogers, J.M., Kavlock, R.J., Shuey, D.L., Cameron, A.M., Ellis,D.H., Logsdon, T.R., Merriman, J., and Setzer, R.W., Toward a biologically based dose-responsemodel for developmental toxicity of 5-fluorouracil in the rat: acquisition of experimental data, Toxicol.Sci., 59, 37, 2001.102. Setzer, R.W., Lau, C., Mole, M.L., Copeland, M.F., Rogers, J.M., and Kavlock, R.J., Toward abiologically based dose-response model for developmental toxicity of 5-fluorouracil in the rat: amathematical construct, Toxicol. Sci., 59, 49, 2001.103. Barton, H.A., Andersen, M.E., and Clewell, J.H., Harmonization: developing consistent guidelinesfor applying mode of action and dosimetry information to cancer and noncancer risk assessment,Human Ecol. Risk Assess., 4, 75, 1998.104. Barton, H.A., Deisinger, P.J., English, J.C., Gearhart, J.M., Faber, W.D., Tyler, T.R., Banton, M.I.,Teeguarden, J., and Andersen, M.E., Family approach for estimating reference concentrations/dosesfor series of related organic chemicals, Toxicol. Sci., 54, 251, 2000.105. Barton, H.A. and Clewell, J.H., Evaluating effects of trichloroethylene: dosimetry, mode of action,and risk assessment, Environ. Health Perspect., 108(Suppl. 2), 323, 2000.106. Clewell, J.H., Andersen, M.E., and Barton, H.A., A consistent approach for the application of pharmacokineticmodeling in cancer and noncancer risk assessment, Environ. Health Perspect., 110, 85, 2002.107. Crump, K.S., A new method for determining allowable daily intakes, Fund. Appl. Toxicol., 4, 854,1984.108. U.S. Environmental Protection Agency, Benchmark Dose Technical Guidance Document, ExternalReview Draft, EPA/630/R-00/001, October 2000; available at http://cfpub.epa.gov/ncea/raf/recordisplay.cfm?deid=20871.109. Jarabek, A.M., Consideration of temporal toxicity challenges current default assumptions, Inhal.Toxicol., 7, 927, 1995.110. Kimmel, G.L., Exposure-duration relationships: the risk assessment process for health effects otherthan cancer, Inhal. Toxicol., 7, 873, 1995.111. Witschi, H., The story of the man who gave us Haber’s Law, Inhal. Toxicol., 9, 201, 1997.112. Witschi, H., Some notes on the history of Haber’s Law, Toxicol. Sci., 50, 164, 1999.113. Eastern Research Group, Summary of the U.S. EPA Workshop on the Relationship Between ExposureDuration and Toxicity, Prepared for the U. S. Environmental Protection Agency, Risk AssessmentForum, Washington, D.C., under Contract No. 68-D5-0028, 1998; available from: Technical InformationStaff (202-564-3261).114. Pierano, W.B., Mattie, D., and Smith, P., Proceedings of the Conference on Temporal Aspects in RiskAssessment for Noncancer Endpoints, Inhal. Toxicol, 7, 837, 1995.115. Tzimas, G., Thiel, R., Chahoud, I., and Nau, H., The area under the concentration-time curve of alltrans-retinoicacid is the most suitable pharmacokinetic correlate to the embryotoxicity of this retinoidin the rat, Toxicol. Appl. Pharmacol., 143, 436, 1997.116. Weller, E., Long, N., Smith, A., Williams, P., Ravi, S., Gill, J., Henessey, R., Skornik, W., Brain, J.,Kimmel, C., Kimmel, G., <strong>Ho</strong>lmes, L. and Ryan, L., Dose-rate effects of ethylene oxide exposure ondevelopmental toxicity, Toxicol. Sci., 50, 259, 1999.117. Kimmel, G.L., Williams, P.L., Claggett, T.W., and Kimmel, C.A., Response-surface analysis ofexposure-duration relationships: the effects of hyperthermia on embryonic development of the rat invitro, Toxicol. Sci., 69, 391, 2002.118. U.S. Environmental Protection Agency, Methods for Derivation of Inhalation Reference Concentrationsand Application of Inhalation Dosimetry, EPA/600/8-90/066F, 1994; available from: NationalTechnical Information Service, Springfield, VA.119. Faustman, E.M., Allen, B.C., Kavlock, R.J., and Kimmel, C.A., Dose-response assessment for developmentaltoxicity: I. Characterization of data base and determination of NOAELs, Fundam. Appl.Toxicol., 23, 478, 1994.120. Allen, B.C., Kavlock, R.J., Kimmel, C.A., and Faustman, E.M., Dose-response assessment for developmentaltoxicity: II. Comparison of generic benchmark dose estimates with NOAELs, Fundam. Appl.Toxicol., 23, 487, 1994.121. Allen, B.C., Kavlock, R.J., Kimmel, C.A., and Faustman, E.M., Dose-response assessment for developmenttoxicity: III. Statistical models, Fundam. Appl. Toxicol., 23, 496, 1994.© 2006 by Taylor & Francis Group, LLC
DEVELOPMENTAL AND REPRODUCTIVE TOXICITY RISK ASSESSMENT 873122. Kavlock, R.J., Allen, B.C., Kimmel, C.A. and Faustman, E.M., Dose-response assessment for developmentaltoxicity. IV. Benchmark doses for fetal weight changes, Fundam. Appl. Toxicol., 26, 211, 1995.123. Moore, J.A. and an IEHR Expert Scientific Committee, An assessment of lithium using the IEHRevaluative process for assessing human developmental and reproductive toxicity of agents, Reprod.Toxicol., 9, 175, 1995.124. Moore, J.A. and an Expert Scientific Committee, An assessment of boric acid and borax using theIEHR Evaluative Process for assessing human developmental and reproductive toxicity of agents,Reprod. Toxicol., 11, 123, 1997.125. Dourson, M.L., Felter, S.P., and Robinson, D., Evolution of science-based uncertainty factors innoncancer risk assessment, Regul. Toxicol. Pharmacol., 24, 108, 1996.126. Renwick, AG., Toxicokinetics in infants and children in relation to the ADI and TDI, Food Addit.Contam., 15(Suppl), 17, 1998.127. Renwick, A.G. and Lazarus, N.R., Human variability and noncancer risk assessment — an analysisof the default uncertainty factor, Regul. Toxicol. Pharmacol., 27, 3, 1998.128. Calabrese, E.J., Assessing the default assumption that children are always at risk, Human Ecol. RiskAssess., 7, 37, 2001.129. Schilter, B., Renwick, A.G., and Huggett, A.C., Limits for pesticide residues in infant food: a safetybasedapproach, Regul. Toxicol. Pharmacol., 24, 126, 1996.130. Peleki, M., Gephart, L.A., and Lerman, S.E., Physiological-model-based derivation of the adult andchild pharmacokinetic intraspecies uncertainty factors for volatile organic compounds, Regul. Toxicol.Pharmacol., 33, 12, 2001.131. U.S. Environmental Protection Agency, Guidelines for estimating exposures, Fed. Reg., 51, 34042, 1986.132. U.S. Environmental Protection Agency, Guidelines for exposure assessment, Fed. Reg., 57, 22888,May 29, 1992.133. U.S. Environmental Protection Agency, Exposure Factors Handbook, Office of Health and EnvironmentalAssessment, Washington, D.C., EPA/600/8-98/043, 1990.134. U.S. Environmental Protection Agency, Child-Specific Exposure Factors Handbook (Interim Report),EPA-600-P-00-002B, 01 Sep 2002, Office of Research and Development, National Center for EnvironmentalAssessment, Washington Office, Washington, D.C., 2002, p. 448; available at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=55145135. Daston, G.P., Relationships between maternal and developmental toxicity, in Developmental Toxicology,2nd ed., Kimmel, C.A. and Buelke-Sam, J., Eds., Raven Press, New York, 1994, p. 189.136. Manton, W.I., Angle C.R., Stanek, K.L., Kuntzelman, D., Reese, Y.R., and Kuehnemann, T.J., Releaseof lead from bone in pregnancy and lactation, Environ. Res., 92, 139, 2003.137. Silbergeld, E.K., Lead in bone: implications for toxicology during pregnancy and lactation, Environ.Health Perspect., 91, 63, 1991.138. Silbergeld, E.K., Schwartz, J., and Mahaffey, K., Lead and osteoporosis: mobilization of lead frombone in postmenopausal women, Environ. Res., 47, 79, 1988.139. Watson, L.R., Gandley, R., and Silbergeld, E.K., Lead: interactions of pregnancy and lactation withlead exposure in rats, Toxicologist, 13, 349, 1993.140. Herbst, A.L., Ulfelder, H., and Poskanzer, D.C., Adenocarcinoma of the vagina. Association ofmaternal stilbestrol therapy with tumor appearance in young women, New Engl. J. Med., 284, 878,1971.141. Herbst, A.L., Hubby, M.M., Blough, R.R., and Azizi, F., A comparison of pregnancy experience inDES-exposed and DES-unexposed daughters, J. Reprod. Med., 24, 62, 1980.142. Olshan, A.F. and Mattison, D.R., Eds., Male-Mediated Developmental Toxicity, Plenum Press, NewYork, 1994.143. Robaire, B. and Hales, B.F., Eds., Advances in Male Mediated Developmental Toxicity, Advances inExperimental Medicine and Biology, Vol. 518, Kluwer Academic, New York, 2003, p. 298.144. Selevan, S.G., Kimmel, C.A., and Mendola, P., Identifying critical windows of exposure for children’shealth, Environ. Health Perspect., 108(Suppl 3), 451, 2000.145. U.S. Environmental Protection Agency, Pesticide products containing dinoseb; notices, Fed. Reg., 51,36645, 1986.© 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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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 811from monstrous, us
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HUMAN STUDIES 813A distinction is s
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HUMAN STUDIES 815G. Childhood Cance
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