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

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260 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITION93. Strong, R.M., The order, time and rate of ossification of the albino rat (Mus norvegicus albinus)skeleton, Am. J. Anat., 36, 313, 1928.94. Walker, D.G. and Wirtschafter, Z.T., The Genesis of the Rat Skeleton, Charles C. Thomas, Springfield,IL, 1957.95. Banerjee, B.N. and Durloo, R.S., Incidence of teratological anomalies in control Charles River CD ®strain rats, Toxicology, 1, 151, 1973.96. Perraud, J., Levels of spontaneous malformations in the CD ® rat and the CD-1 ® mouse, Lab. Anim.Sci., 26, 293, 1976.97. Charles River Laboratories, Embryo and Fetal Developmental Toxicity (Teratology) Control Data inthe Charles River Crl:CD ® BR Rat, Charles River Laboratories, Inc., Wilmington, MA, 1988.98. Woo, D.C. and Hoar, R.M., Reproductive performance and spontaneous malformations in controlCharles River CD ® rats: a joint study by MARTA, Teratology, 19, 54A, 1979.99. Fritz, H., Grauwiler, J., and Himmler, H., Collection of control data from teratological experimentsin mice, rat and rabbits, Arzneim-Forsch/Drug Res., 28, 1410, 1978.100. Palmer, A.K., Sporadic malformations in laboratory animals and their influence in drug testing, DrugsFetal Dev. Adv. Biol. Med., 27, 45, 1972.101. DePass, L.R. and Weaver, E. V., Comparison of teratogenic effects of aspirin and hydroxyurea in theFischer 344 and Wistar strains, J. Toxicol. Environ. Health, 15, 297, 1982.102. Wolkowski-Tyl, R., Jones-Price, C., Ledoux, T.A., Marks, T.A., and Langhoff-Paschke, L., Teratogenicityevaluation of technical grade dinitrotoluene in the Fischer 344 rat, Teratology, 23, 70A, 1981.103. Wolkowski-Tyl, R., Jones-Price, C., Ledoux, T.A., Marks, T.A., and Langhoff-Paschke, L., Teratogenicityevaluation of aniline HCl in the Fischer 344 rat, Teratology, 23, 70A, 1981.104. Wolkowski-Tyl, R., Phelps, M., and Davis, J.K., Structural teratogenicity evaluation of methyl chloridein rats and mice after inhalation exposure, Teratology, 27, 18, 1983.105. Wolkowski-Tyl, R., Jones-Price, C., Marr, M.C., and Kimmel, C.A., Teratologic evaluation of diethylhexylphthalate (DEHP) in Fischer 344 rats, Teratology, 27, 85A, 1983.106. Jones-Price, C., Wolkowski-Tyl, R., Marks, A., Langhoff-Paschke, L., Ledoux, T. A., and Reel, J. R.,Teratologic and postnatal evaluation of aniline hydrochloride in the Fischer 344 rat, Toxicology Appl.Pharmacol., 77, 465, 1985.107. Hayes, W.C., Cobel-Geard, S.R., Hanley, T.R., Murray, J.S., Freshour, N.L., Rao, K.S., and John,J.A., Teratogenic effects of vitamin A palmitate in Fischer 344 rats, Drug Chem. Toxicology, 4, 283,1981.108. Peters, M.A. and Hudson, P.M., Effects of totigestational exposure to ethchlorvynol on developmentand behavior, Ecotoxicology Environ. Safety, 5, 494, 1981.109. Peters, M.A., Hudson, P.M., and Dixon, R.L., Effect of totigestational exposure to methyl n-butylketone on postnatal development and behavior, Ecotoxicology Environ. Safety, 5, 291, 1981.110. John, J.A., Hayes, W.C., Hanley, T.R., Cobel-Geard, S.R., Quast, J.F., and Rao, K.S., Behavioral andteratogenic potential of vitamin A in the Fischer 344 rat, Teratology, 24, 55A, 1981.111. Keller, W.C., Inman, R.C., and Back, K.C., Evaluation of the embryotoxicity of JP10 in the rat,Toxicologist, 1, 30, 1981.112. Snellings, W.M., Pringle, J.L., Dorko, J.D., and Kintigh, W.J., Teratology and reproduction studieswith rats exposed to 10, 33, or 100 ppm of ethylene oxide (EO), Toxicol. Appl. Pharmacol., 48, A84,1979.113. Sunderman, F., Shen, S.K., Mitchell, J.M., Allpass, P.R., and Damjanov, I., Embryotoxicity and fetaltoxicity of nickel in rats, Toxicology Appl. Pharmacol., 43, 381, 1978.114. Sunderman, F., Allpass, P.R., Mitchell, J.M., Baselt, R.C., and Albert D.M., Eye malformations inrats: induction by prenatal exposure to nickel carbonyl, Science, 203, 550, 1979.115. Bus, J.S., White, E.L., Tyl, R.W., and Barrow, C.S., Perinatal toxicity and metabolism of n-hexane inFischer 344 rats after inhalation exposure during gestation, Toxicol. Appl. Pharmacol., 51, 295, 1979.116. Olson, C.T. and Back, K.C., Methods for teratogenic screening of air force chemicals, US NTIS ADReport, AD-A052002, 1978.117. Wolkowski-Tyl, R., Lawton, A.D., Phelps, M., and Hamm, Jr., T.E., Evaluation of heart malformationsin B6C3F1 mouse fetuses induced by in utero exposure to methyl chloride, Teratology, 27, 197, 1983.118. Cozens, D.D., Abnormalities of the external form and of the skeleton in the New Zealand Whiterabbit, Food. Cosmet. Toxicology, 3, 695, 1965.© 2006 by Taylor & Francis Group, LLC
DEVELOPMENTAL TOXICITY TESTING — METHODOLOGY 261119. DeSesso, J.M. and Jordan, R.L., Drug-induced limb dysplasias in fetal rabbits, Teratology, 15, 199,1977.120. Hartman, H.A., The fetus in experimental teratology, in The Biology of the Laboratory Rabbit,Weisbroth, S.H., Flatt, R.E., and Kraus, A.L., Eds., Academic Press, New York, 1974, p. 92.121. McClain, R.M. and Langhoff, L., Teratogenicity of diphenylhydantoin in the New Zealand whiterabbit, Teratology, 21, 371, 1980.122. Palmer, A.K., The design of subprimate animal studies, in Handbook of Teratology, Vol. 4, Wilson,J.G. and Fraser, F.C., Eds., Plenum Press, New York, 1978, p. 215.123. Stadler, J., Kessedjian, M.-J., and Perraud, J., Use of the New Zealand white rabbit in teratology:incidence of spontaneous and drug-induced malformations, Food Chem. Toxicol., 21, 631, 1983.124. Woo, D.C. and Hoar, R.M., Reproductive performance and spontaneous malformations in controlNew Zealand white rabbits: a joint study by MARTA, Teratology, 25, 82A, 1982.125. Kimmel, C.A. and Wilson, J.G., Skeletal deviations in rats: malformations or variations? Teratology,8, 309, 1973.126. Aliverti, V., Bonanomi, L., Giavini, E., Leone, V.G., and Mariani, L., The extent of fetal ossificationas an index of delayed development in teratogenic studies on the rat, Teratology, 20, 237, 1979.127. Woo, D.C. and Hoar, R.M., Apparent hydronephrosis as a normal aspect of renal development in lategestation of rats: the effect of methyl salicylate, Teratology, 6, 191, 1972.128. Weil, C.S., Selection of the valid number of sampling units and a consideration of their combinationin toxicological studies involving reproduction, teratogenesis, or carcinogenesis, Fd. Cosmet. Toxicol.,8, 177, 1970.129. U.S. Food and Drug Administration, Guidelines for Reproduction Studies for Safety Evaluation ofDrugs for Human Use, U.S. Food and Drug Administration, Washington, D.C., 1966.130. U.S. Food and Drug Administration, Federal Food, Drug, and Cosmetic Act, Commissioner of Foodand Drugs, Title 21, Chapter I of Code of Federal Regulations (FR), amended by addition of Part II:“Part II — Electronic Records, Electronic Signatures.” Fed. Regist., 62(54), 13464–13466 (March 20,1997)131. U.S. Environmental Protection Agency, Part V, 40 CFR parts 3, 51, et al., Establishment of ElectronicReporting: Electronic Records; Proposal Rule. Fed. Regist., 66(170), 46162–46195, 2001.© 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/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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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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Table 6.6DescriptionComparative ges
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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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Table 6.11DescriptionIntermediateme
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CHAPTER 7Developmental Toxicity Tes
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DEVELOPMENTAL TOXICITY TESTING —
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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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CHAPTER 13Use of Toxicokinetics in
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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 829B. The Formation o
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HUMAN STUDIES 837with spina bifida
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CHAPTER 21Developmental and Reprodu
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