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

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570 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITION253. Mattison, D.R., Shiromizu, K., and Nightingale, M.S., The role of metabolic activation in gonadaland gamete toxicity, in Occupational Hazards and Reproduction, Hemminki, K, Sorsa, M., and Vainio,H., Eds., Hemisphere, New York, 1985, chap.7.254. Miller, G.E. and Kulkarni, A.P., 1,2-dibromo-3-chloropropane as a substrate for hepatic, renal andtesticular glutathione S-transferases in the rat, Toxicologist, 3, 416A, 1983.255. Kulkarni, A.P. and Mitra, A., Pesticide contamination of food, in Food Contamination from EnvironmentalSources, Simons, M.S. and Nriagu, J., Eds., Adv. Environ. Sci. Technol., Vol. 23, John Wiley,New York, 1990, chap. 9.256. Babich, H., Davis, D.L., and Stotzky, G., Dibromochloropropane (DBCP): a review, Sci. Total Environ.,17, 207, 198.257. Miller, G.E., Brabec, M.J., and Kulkarni, A.P., Mutagenic activation of 1,2-dibromo-3-chloro-propaneby cytosolic glutathione S-transferases and microsomal enzymes, J. Toxicol. Environ. Hlth., 19, 503,1986.258. Guzelian, P.S., Comparative toxicology of chlordecone (kepone) in humans and experimental animals,Ann. Rev. Pharmacol. Toxicol., 22, 89, 1982.259. Gray, T.J.B. and Beamand, J.A., Effect of some phthalate esters and other testicular toxins on primarycultures of testicular cells, Food Cosmet. Toxicol., 22, 123, 1984.260. Boekelheide, K., 2,5-Hexanedione alters microtubule assembly: I. Testicular atrophy, not nervoussystem toxicity, correlates with enhanced tubulin polymerization, Toxic. Appl. Pharmacol., 88, 370,1987.261. Wang, W. and Chapin, R.E., Differential gene expression detected by suppression substractive hybridizationin ethylene glycol monomethyl ether-induced testicular lesion, Toxicol. Sci., 56, 165, 2000.262. Kulkarni, A.P., Treinen, K.A., and Bestervelt, L.L., Human placental Ca 2+ -ATPase: target for organochlorinepesticides? Trophoblast Res., 2, 329, 1987.263. Andersen, H.R., et al., Effects of currently used pesticides in assays for estrogenicity, adrogenicity,and aromatase activity in vitro, Toxicol. Appl. Pharmacol., 179, 1, 2002.264. Naidu, A.K., Naidu, A.K., and Kulkarni, A.P., Aldrin epoxidation: catalytic potential of lipoxygenasecoupled with linoleic acid oxidation, Drug Metab. Disp., 19, 758, 1991.265. Stresser, D.M. and Kupfer, D., Human cytochrome P450-catalyzed conversion of the proestrogenicpesticide methoxychlor into an estrogen. Role of CYP2C19 and CYP1A2 in O-demethylation, DrugMet. Disp., 26, 868, 1998.266. Nicoise, T., Chronic organophosphorus intoxication in women, J. Jpn. Assoc. Rural Med., 22, 756,1974.267. Naidu, A.K., Naidu, A.K., and Kulkarni, A.P., Role of lipoxygenase in xenobiotic oxidation: parathionmetabolism catalyzed by highly purified soybean lipoxygenase, Pestic. Biochem. Physiol., 41, 150,1991.268. Byczkowski, J.Z. and Kulkarni, A.P., Lipoxygenase-catalyzed epoxidation of benzo(a) pyrene-7,8-dihydrodiol, Biochem. Biophys. Res. Commun., 159, 1199, 1989.269. Byczkowski, J.Z. and Kulkarni, A.P., Linoleate-dependent co-oxygenation of benzo(a)pyrene-7,8-dihydrodiol by rat cytosolic lipoxygenase, Xenobiotica, 22, 609, 1992.270. Roy, S. and Kulkarni, A.P., Lipoxygenase: a new pathway for 2-aminofluorene bioactivation. CancerLett., 60, 33, 1991.271. Saillenfait, A.M., et al., Modulation of acrylonitrile-induced embryotoxicity in vitro by glutathionedepletion, Arch. Toxicol., 67, 164, 1993.272. Roy, P. and Kulkarni, A.P., Co-oxidation of acrylonitrile by soybean lipoxygenase and partially purifiedhuman lung lipoxygenase, Xenobiotica, 29, 511, 1999.273. Metzler, M., Biochemical toxicology of diethylstilbestrol, Rev. Biochem. Toxicol., 6, 191, 1984.274. Nunez-Delicado, E., Sanchez-Ferrer, A., and Garcia-Carmona, F., Hydroperoxidative oxidation ofdiethylstilbestrol by lipoxygenase, Arch. Biochem. Biophys., 348, 411, 1997.275. Hu, J. and Kulkarni, A.P., Metabolic fate of chemical mixtures. I. Shuttle oxidant effect of lipoxygenase-generatedradical of chlorpromazine and related phenothiazines on the oxidation of benzidineand other xenobiotics, Teratogen, Carcinogen. Mut., 20, 195, 2000.276. Persad, A.S., Stedeford, T.J., and Kulkarni, A.P., The hyperoxidation of L-dopa by chlorpromazine ina lipoxygenase catalyzed reaction, Toxicologist, 54, 1746A, 2000.© 2006 by Taylor & Francis Group, LLC
CHAPTER 13Use of Toxicokinetics in Developmental andReproductive ToxicologyPatrick J. WierCONTENTSI. Introduction ........................................................................................................................572II. Principles of Absorption, Distribution, Biotransformation, and Elimination ...................572A. Movement across Biological Membranes .................................................................572B. Plasma Protein Binding .............................................................................................573C. Volume of Distribution ..............................................................................................573D. Blood and Seminiferous Tubule Distribution ...........................................................574E. Placental Transfer ......................................................................................................574F. Biotransformation ......................................................................................................575G. Elimination.................................................................................................................576H. Physiological Changes in Pregnancy ........................................................................576I. Physiological Changes in Neonates ..........................................................................577III.Classical Pharmacokinetics................................................................................................578A. Simple Compartmental Models.................................................................................578B. Basic Pharmacokinetic Parameters............................................................................578IV. Physiologically Based Pharmacokinetics ..........................................................................582A. Physiologically Based Pharmacokinetic Models of Pregnancy................................582V. Sampling Strategies............................................................................................................583VI. Regulatory Expectations ....................................................................................................585A. ICH Reproduction Test Guideline.............................................................................585B. ICH Toxicokinetic Guideline.....................................................................................587VII.Toxicokinetics in Developmental and Reproductive Toxicology......................................587A. When Are Toxicokinetics Not Essential?..................................................................588B. Use of Toxicokinetics in Study Design.....................................................................588C. Use of Toxicokinetics in Study Interpretation ..........................................................588D. Use of Toxicokinetics in Risk Assessment ...............................................................590VIII. Conclusions ........................................................................................................................592References ......................................................................................................................................592571© 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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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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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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Formation ofchoroid plexusof latera
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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 9.33Selected 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 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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