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

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NONCLINICAL JUVENILE TOXICITY TESTING 30155000500004500040000Activity (U/brain)Activity (U/g tissue)403530Activity (U/brain)3500030000250002000015000100005000252015105Activity (U/g tissue)0FetusPND 4PND 11AgePND 21PND 42Dam0Figure 8.19Ontogeny of female Crl:CD ® (SD)IGS BR rat brain cholinesterase (fetal tissue pooled regardlessof sex). Data were collected at WIL Research Laboratories, LLC.the first month following birth. As neonatal dogs develop from birth to 3 months of age, thesevalues decline to normal adult ranges. In contrast, many of the other hematology values (neutrophil,lymphocyte, and platelet counts) have similar values from birth through adolescent development.4. Macroscopic and Microscopic EvaluationsMacroscopic and microscopic evaluations are also recommended by the FDA draft guidancedocument for nonclinical juvenile studies. 51 The importance of gross examinations is similar to thatfor standard toxicity studies, although with less emphasis on chronic lesions. Macroscopic changesconsistent with hypoplasia may correlate with changes in growth in juvenile studies. One exampleis a change in the relative size of organs or structures such as the kidneys, liver, testes, or bones.If there are known target organs, based on data from adult animals or humans, these organs shouldbe examined in the juvenile. <strong>Ho</strong>wever, histopathology varies with stage of organ maturity (e.g.,reproductive organs, such as the testes), and these differences between developing and adult animalsmust be considered. As an example, basophilic tubules observed in regenerating tubular epitheliumin an adult kidney are considered evidence of ongoing degeneration of the renal tubule and areconsidered an adverse finding. 127 <strong>Ho</strong>wever, in a juvenile study of the angiotensin converting enzyme(ACE) inhibitor, ramipril, the finding of basophilic tubules on PND 17 and 28 was noted for bothwell-developed tubules and for clusters of relatively undeveloped tubules in both control and treatedanimals. 92 In that study, the adverse change caused by ramipril was the increased incidence ofbasophilic tubules in the treated animals, potentially suggesting a delay in development of thekidneys of these animals. Another ACE inhibitor was also shown to cause arrested maturation ofthe developing kidney (immature glomeruli, distorted and dilated tubules, and relatively few andshort, thick arterioles) when administered to newborn rats. 1285. Physical and Sexual Developmental Landmarks and Behavioral AssessmentsThe assessment of growth can involve evaluation of a variety of different parameters, includingbody weights and landmarks of physical and sexual development. Physical developmental landmarksare commonly included as endpoints in reproductive and developmental toxicity studies© 2006 by Taylor & Francis Group, LLC
Table 8.6Serum chemistry values for beagle dogsPostnatal Day aParameter b 7 14 21 28 42 60 85 108 135ALB (g/dl)M 2.3 ± 0.22 (8) 2.3 ± 0.13 (8) 2.5 ± 0.17 (9) 2.9 ± 0.17 (7) 3 ± 0.13 (7) 2.9 ± 0.13 (7) 3 ± 0.12 (7) 3 ± 0.12 (7) 3.1 ± 0.13 (7)F 2.3 ± 0.1 (9) 2.3 ± 0.1 (9) 2.5 ± 0.16 (10) 2.9 ± 0.17 (8) 3 ± 0.15 (8) 3 ± 0.14 (8) 3.1 ± 0.09 (8) 3.1 ± 0.1 (8) 3.2 ± 0.13 (8)ALP (U/l)M 223 ± 50.3 (8) 199 ± 38.2 (9) 168 ± 7.5 (7) 178 ± 12.3 (7) 232 ± 34.1 (7) 246 ± 55.3 (7) 253 ± 29 (7) 209 ± 27.4 (7) 167 ± 19.6 (7)F 214 ± 45 (9) 183 ± 53.3 (10) 168 ± 16.7 (8) 167 ± 12 (8) 217 ± 41.8 (8) 247 ± 51.6 (8) 253 ± 22.5 (8) 213 ± 26.6 (8) 168 ± 25.9 (8)ALAT (U/l)M 28 ± 17.2 (8) 15 ± 3.1 (9) 17 ± 2.6 (7) 24 ± 5.3 (7) 36 ± 11.9 (7) 33 ± 5.7 (7) 37 ± 6.7 (7) 39 ± 7.5 (7) 40 ± 3.2 (7)F 24 ± 11.5 (9) 17 ± 6.4 (10) 17 ± 3.5 (8) 21 ± 7.5 (8) 32 ± 13.7 (8) 31 ± 6.3 (8) 38 ± 5.5 (8) 39 ± 7.4 (8) 41 ± 2.9 (8)ASAT (U/l)M 53 ± 25 (8) 34 ± 11.7 (9) 29 ± 6.2 (7) 28 ± 6.4 (7) 30 ± 1.8 (7) 34 ± 8.3 (7) 35 ± 12.1 (7) 36 ± 7 (7) 30 ± 3.3 (7)F 49 ± 26.6 (9) 31 ± 10.6 (10) 28 ± 8 (8) 23 ± 6.5 (8) 29 ± 4.6 (8) 32 ± 6 (8) 31 ± 7.9 (8) 34 ± 3 (8) 31 ± 4 (8)TOT. BIL (mg/dl)M 0.7 ± 0.22 (8) 0.5 ± 0.28 (8) 0.4 ± 0.11 (9) 0.4 ± 0.13 (7) 0.2 ± 0.07 (7) 0.2 ± 0.06 (7) 0.2 ± 0.03 (7) 0.1 ± 0.05 (7) 0.1 ± 0.03 (7)F 0.9 ± 0.49 (9) 0.5 ± 0.24 (9) 0.4 ± 0.06 (10) 0.3 ± 0.1 (8) 0.3 ± 0.11 (8) 0.2 ± 0.06 (8) 0.2 ± 0.08 (8) 0.2 ± 0.04 (8) 0.2 ± 0.03 (8)UREA N (mg/dl)M 30 ± 17 (8) 21 ± 5.5 (9) 16 ± 1.6 (7) 15 ± 2.6 (7) 13 ± 3.3 (7) 11 ± 2.4 (7) 15 ± 4.7 (7) 15 ± 5.1 (7) 11 ± 2 (7)F 26 ± 3.7 (9) 21 ± 4.6 (10) 16 ± 3.2 (8) 14 ± 1.4 (8) 13 ± 2.9 (8) 11 ± 3 (8) 13 ± 1.8 (8) 14 ± 3.5 (8) 12 ± 2.9 (8)CHOL (mg/dl)M 285 ± 128.8 (8) 218 ± 46.1 (9) 233 ± 41.9 (7) 239 ± 46 (7) 156 ± 36.3 (7) 127 ± 14 (7) 143 ± 10.8 (7) 166 ± 10.5 (7) 183 ± 10.7 (7)F 249 ± 39.4 (9) 241 ± 39.7 (10) 263 ± 49 (8) 259 ± 42.1 (8) 171 ± 37.5 (8) 126 ± 11.7 (8) 143 ± 19.4 (8) 166 ± 16.5 (8) 174 ± 14.7 (8)CREAT (mg/dl)M 0.1 ± 0.061 (8) 0.06 ± 0.046 (9) 0.03 ± 0.039 (7) 0.04 ± 0.045 (7) 0.06 ± 0.059 (7) 0.14 ± 0.057 (7) 0.14 ± 0.073 (7) 0.19 ± 0.099 (7) 0.29 ± 0.078 (7)F 0.08 ± 0.067 (9) 0.06 ± 0.066 (10) 0.05 ± 0.039 (8) 0.04 ± 0.048 (8) 0.07 ± 0.051 (8) 0.16 ± 0.044 (8) 0.13 ± 0.057 (8) 0.21 ± 0.065 (8) 0.32 ± 0.079 (8)302 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITION© 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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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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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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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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DEVELOPMENTAL AND REPRODUCTIVE TOXI
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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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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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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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