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

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1124 DEVELOPMENTAL REPRODUCTIVE TOXICOLOGY: A PRACTICAL APPROACH, SECOND EDITIONHumansIn humans, the periodicity of wakefulness and sleep is observed by between 10-11 weeks of age(de Roquefeuil et al., 1993; Hellbrügge, 1960). Between the ages of 18 to 21 weeks, the longestduration of sleep occurred between 11 pm and 5 am (Kleitman and Engelmann, 1953) (Moore andUcko, 1957). De Roquefeuil et al. (de Roquefeuil et al., 1993) examined the sleep-wake rhythmsof 12 children admitted to a day-care at 4-5 months of age until approximately 15 months of age.The circadian rhythm of wakefulness and sleep is well established by 4 months of age. In this samestudy, the results indicated that at 7, 11 and 15 months of age the number of sleep spans continuedto decrease in a 24-hr period (4, 3 and 2, respectively), and the duration of an individual sleep spanprogressively increased (200, 210 and 260 minutes, respectively).RatsUp until PND12, nursing and burrowing for preferred sleeping and nursing positions are thedominant activities in rats (Bolles and Woods, 1964). Any movement by one pup is likely to disturbthe entire litter. Gradually after PND 12, activities such as exploring and grooming occur withincreasing frequency. By PND 15, some rats prefer to bury their heads under the litter to sleepwhile others prefer to climb on top. By PND 19, sleeping becomes quieter with less twitching andmoving around. By PND 27, an individual rat can sleep soundly while littermates are playing ontop of him. Interestingly during the first 3 weeks of life, rat pups do not exhibit the normal diurnalsleep cycle of adult animals, i.e., sleep during daylight, and activity at night (Bolles and Woods,1964). Alföldi et al. (Alföldi et al., 1990) demonstrated that by PND 23 waking activities predominatedduring the 12-h dark period.DogsThe development of electrocortical activity as measured by EEG in the dog has been well describedby Fox (Fox, 1971). The results of the EEG analysis indicated changes in behavioral state (e.g.,sleep, alertness) were not accompanied by significant changes in the EEG during the first twoweeks of life. Up until 7 days of age, sleep in the puppy consisted of mainly body jerks and twitchesincluding occasional vocalizations, sucking, crawling and scratching movements (which couldeasily be mistaken for an alert state). After the second week of life, slow-wave activity began toemerge and was associated with the development of quiet sleep. Three weeks of age marks atransitional point when the relative durations of wakefulness (or attentiveness) and activated sleepare similar, and the duration of quiet sleep is increasing. The onset of the mature EEG occursbetween 3 and 4 weeks of age, which also marks a critical period of socialization (Scott, 1962).By 4-5 weeks of age, the EEG has developed the full range of activity that is present in the adult.Non-Human PrimatesInfant monkeys have a less well-defined sleep/wake pattern than adult animals. By 2 to 8 days ofage, neonatal monkeys already tend to sleep more frequently at night than during the day (Bowmanet al., 1970).Conclusions for Sleep-Wake Cycle DevelopmentWhile development of adult-like sleep-wake cycles occurs postnatally, utilizing sleep-wake cyclesas a measure in juvenile toxicity studies will provide limited insight because its development isnot well understood.© 2006 by Taylor & Francis Group, LLC
POSTNATAL DEVELOPMENTAL MILESTONES 1125Table 8“Semi-Adult-like”Sleep CycleSummary of Sleep-Wake CycleApproximate Postnatal AgeAbility Begins to EmergesHuman3–15 monthsRat PND 15–23Dog2–4 weeksNon-Human Primate 2–8 daysOverall ConclusionsThere is no species that provides a direct correlation to human neurological development for allfunctional measures discussed. However, when development is tracked within particular functionaldomains (e.g., sensory or locomotor development), the common laboratory species are born insimilar states of CNS development as the human, and there is an extended period of postnatal lifewhere these species develop similar to humans. Both the rat and dog are appropriate models forcomparative CNS development, with neither showing a clear advantage. Non-human primates aremore advanced at birth for several of the most commonly measured endpoints of CNS development.Because of their advanced cognitive evolution monkeys are more similar to humans in cognitivedevelopment. However, for most applications, the rat is likely to be the preferred species forevaluation of CNS function in juvenile toxicity testing, but should not be chosen as the defaultspecies for all studies. It is important to select the species that most appropriately correlates tohumans within the functional domain of concern.Additional Research NeedsThe ontogeny of memory is less well understood than adult memory systems for several reasons.First, unlike adults, infants do not typically suffer discrete brain lesions, which have helpedresearchers make associations between different types of memory and specific brain regions.Second, cognitive and linguistic limitations in infants provide additional challenges, which makestudies of the development of early memory challenging.Also, there is a strong need have additional reviews on postnatal development of the CNS whichinclude both neuroanatomical and neurochemical maturation. Further research on the ontogeny ofneurological development in all species is necessary in order to design better cognitive assessmentsof juvenile toxicity.REFERENCESAdams-Curtis LE, and Fragaszy DM (1994) Development of manipulation in capuchin monkeys during thefirst 6 months. Developmental Psychobiology 27: 123-136Adams J (1986) Methods of Behavioral Teratology. In: Riley EP, Vorhees CV (eds) Handbook of BehavioralTeratology. Plenum Press, New York, pp 67-97Alberts JA (1984) Sensory-perceptual development in the Norway rat: A view toward comparative studies.In: R.Kail, Spear NE (eds) Comparative Perspectives on the Development of Memory. Erlbaum,Hillsdale, NJ, pp 65-101Alföldi P, Tobler, and Borbely A (1990) Sleep regulation in rats during early development. American Journalof Physiology 258: R634-R644Almli CR, and Fisher RS (1977) Infant rats: sensorimotor ontogeny and effects of substantia nigra destruction.Brain Res. Bull. 2: 425-459Altman J, and Sudarshan K (1975) Postnatal development of locomotion in the laboratory rat. Anim. Behav.23: 896-920© 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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46 DEVELOPMENTAL REPRODUCTIVE TOXIC
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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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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 805100908070Induced a
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HUMAN STUDIES 80940003500Mean birth
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HUMAN STUDIES 811from monstrous, us
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HUMAN STUDIES 829B. The Formation o
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HUMAN STUDIES 837with spina bifida
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HUMAN STUDIES 83926. Haglund, B. an
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CHAPTER 21Developmental and Reprodu
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There are six factors that may affe
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