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

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592 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITIONCAC 1C 2B15 30 60Time (minutes)Figure 13.5Theoretical blood plasma compound concentration (C) vs. time curves following a single bolusintravenous injection (A) or continuous intravenous infusion (B). The AUCs are comparable,whereas the elapsed time exceeding a certain concentration (C 1 or C 2 ) is different. The higherof these concentrations (C 1 ) is only exceeded following the bolus dose, while the duration of timeduring which C 2 is exceeded is greater following infusion.VIII. CONCLUSIONSThe rate and extent of absorption, distribution, biotransformation, and elimination influence thetoxicity potential of xenobiotics. Pharmacokinetic parameters reflecting these events are used indevelopmental and reproductive toxicology study design, in species selection, and in the rationalefor route and dose selection. Although general assessments of systemic exposure and metabolismcan be collected in a relatively standardized manner, toxicokinetic assessments are ideally madein the context of having first identified the nature of the toxicity, critical “windows” of exposure,and sensitive vs. nonresponsive species. This is because toxicokinetics is not merely the assessmentof pharmacokinetics in the toxicology laboratory but is the determination of the relationshipsbetween the compound’s absorption, distribution, biotransformation, and elimination, and theexpression of toxicity. These relationships, based on classical pharmacokinetic parameters andphysiologically based models, can be used to explain experimental results and to extrapolate amongdifferent exposure conditions or between species. In that regard, toxicokinetics plays an integralrole in the risk assessment of developmental and reproductive toxicity.REFERENCES1. Crawford, J.S., The placenta, drugs, and the fetus, in Principles and Practice of Obstetric Anesthesia,5th ed., Blackwell Scientific Publications, Oxford, 1984, p. 132.2. Morriss, Jr., F.H. and Boyd, R.D.H., Placental Transport, in The Physiology of Reproduction, Knobil,E. and Neill, J., Eds., Raven Press Ltd., New York, 1988, chap. 50.3. Rozman, K.K. and Klaassen, C.D., Absorption, distribution, and excretion of toxicants, in Casarettand Doull’s Toxicology: The Basic Science of Poisons, 6th ed., Klaassen, C.D., Ed., McGraw-Hill,New York, 2001, chap. 5.4. Landas, G.R., et al., Placental p-glycoprotein deficiency enhances susceptibility to chemically inducedbirth defects in mice, Reprod. Toxicol., 12, 457, 1998.5. Goldstein, A., Aronow, L., and Kalman, S.M., Principles of Drug Action: The Basics of Pharmacology,2nd ed., John Wiley & Sons, New York, 1974, chap 2.6. Goldstein, A., Aronow, L., and Kalman, S.M., Principles of Drug Action: The Basics of Pharmacology,2nd ed., John Wiley & Sons, New York, 1974, p. 821.© 2006 by Taylor & Francis Group, LLC
USE OF TOXICOKINETICS IN DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY 5937. Dym, M. and Fawcett, D.W., The blood-testis barrier in the rat and the physiological compartmentationof the seminiferous epithelium, Biol. Reprod., 3, 300, 1970.8. Setchell, B.P., Vogimayr, J.K., and Waites, G.M.H., A blood-testis barrier restricting passage fromblood lymph into rete testis fluid but not into lymph, J. Physiol., 200, 73, 1969.9. Okumura, K., Lee, I.P., and Dixon, R.L., Permeability of selected drugs and chemicals across theblood-testis barrier of the rat, J. Pharmacol. Exp. Ther., 194, 89, 1975.10. Hendrikse, N.H., et al., Complete in vivo reversal of p-glycoprotein pump function in the blood-brainbarrier visualized with positron emission tomography, Br. J. Pharmacol., 124, 1413, 1998.11. Hughes, C.S., et al., Modulation of doxorubicin concentration by cyclosporin A in brain and testicularbarrier tissues expressing p-glycoprotein in rats, J. Neuro-Oncology, 37, 45, 1998.12. Choo, E.F., et al., Pharmacological inhibition of p-glycoprotein transport enhances the distribution ofHIV-1 protease inhibitors into brain and testes, Drug Metabol. Disposition, 28, 655, 2000.13. Sieber, S.M. and Fabro, S., Identification of drugs in the preimplantation blastocyst and in the plasma,uterine secretion and urine of the pregnant rabbit, J. Pharmacol. Exp. Ther., 176, 65, 1971.14. McLachlan, J.A., et al., Accumulation of nicotine in the uterine fluid of the six-day pregnant rabbit,Fertil. Steril., 27, 1204, 1967.15. Beck, F., Comparative placental morphology and function, in Developmental Toxicology, Kimmel,C.A. and Buelke-Sam, J., Eds., Raven Press, New York, 1981, p. 35.16. Amoroso, E.C., Placentation, in Marshall’s Physiology of Reproduction, 3rd ed., Parkes, A.S., Ed.,Longmans, London, 1952, Vol. II, chap. 15.17. Mirkin, B.L., Perinatal pharmacology: placental transfer, fetal localization, and neonatal dispositionof drugs, Anesthesiology, 43, 156, 1975.18. Williams, R.T., Detoxification Mechanisms, 2nd ed., Wiley, New York, 1971.19. Parkinson, A., Biotransformation of xenobiotics, in Casarett and Doull’s Toxicology: The BasicScience of Poisons, 6th Ed., Klaassen, C.D., Ed., McGraw-Hill, New York, 2001, chap. 6.20. Juchau, M.R., Mechanisms of drug biotransformation reactions in the placenta, Fed. Proc., 31, 48,1972.21. Juchau, M.R., Drug biotransformation in the placenta, Pharmacol. Ther., 8, 501, 1980.22. Heinrichs, W.L. and Juchau, M.R., Extrahepatic drug metabolism: the gonads, in Extrahepatic Metabolismof Drugs and Other Foreign Compounds, Gram, T.E., Ed., SP Medical and Scientific Books,New York, 1980, p. 313.23. Ishimura, K., et al., Ultrastructural and immunohistochemical studies on steroid-secreting cells oftestis and ovary of normal and 3-methylcholanthrene-treated mice, Cell & Tissue Research, 245, 681,1986.24. Batt, A.M., et al., Enzyme induction by drugs and toxins, Clinica Chimica Acta, 209, 109, 1992.25. Krishna, D.R. and Klotz, U., Extrahepatic metabolism of drugs in humans, Clin. Pharmacokinet., 26,144, 1994.26. Slikker, W. and Miller, R.K., Placental metabolism and transfer: role in developmental toxicology, inDevelopmental Toxicology, 2nd ed., Kimmel, C.A. and Buelke-Sam, J., Eds., Raven Press, New York,1994, p. 245.27. Ring, J.A., et al., Fetal hepatic drug elimination, Pharmacol. Ther., 84, 429, 1999.28. Thomas, J.A., Curto, K.A., and Thomas, M.J., MEHP/DEHP gonadal toxicity and effects on rodentaccessory sex organs, Environ. Health Perspect., 45, 85, 1982.29. Foster, P.M.D., et al., Testicular toxicity of 2-methoxyacetaldehyde, a possible metabolite of ethyleneglycol monomethyl ether in the rat, Toxicol. Lett., 32, 73, 1986.30. Boekelheide, K., 2,5-Hexanedione alters microtubule assembly: I. Testicular atrophy, not nervoussystem toxicity, correlates with enhanced tubulin polymerization, Toxicol. Appl. Pharmacol., 88, 370,1987.31. Gerber, N. and Lynn, R.K., Excretion of methadone in semen from methadone addicts; comparisonwith blood levels, Life Sci., 19, 787, 1976.32. Swanson, B.N., et al., Seminal excretion, vaginal absorption, distribution and whole blood kineticsof d-methadone in the rabbit, J. Pharmacol. Exp. Ther., 206, 507, 1978.33. Taylor, S.M., et al., The seminal excretion, plasma elimination, tissue distribution and metabolism ofnaltrexone in the rabbit, J. Pharmacol. Exp. Ther., 213, 289, 1980.© 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/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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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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Table 6.6DescriptionComparative ges
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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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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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CHAPTER 10Testing for Reproductive
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CHAPTER 12Role of Xenobiotic Metabo
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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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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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CHAPTER 21Developmental and Reprodu
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