Postnatal studies

No information was located concerning whether the developmental process is altered in humans exposed to endosulfan either prenatally or postnatally. Studies in animals have provided inconclusive evidence (FMC 1980b, 1981 Gupta et al. 1978 Hoechst 1982, 1984a), and further well-conducted research would be helpful to clarify this issue. 

Stewart J (2009) Developmental toxicity testing of monoclonal antibodies an enhanced pre- and postnatal study design option. Reprod Toxicol 28 220-225... 

Key words Enhanced pre-and postnatal study, ePPND, Nonhuman primates, Cynomolgus monkey... 

Weinbauer GF, Fuchs A, Niehaus M, Luetjens CM (2011) The enhanced pre- and postnatal study for nonhuman primates updates and perspectives. Birth Defects Res C Embryo Today Reviews 93 324-333... 

PYAP Tablet coatings/ink component for capsules Single dose in various species, repeat dose (oral gavage or diet and up to 2 yrs in duration in rat and dog) and reproduction (fertility study in rat, embryo-fetal studies in rat and rabbit, and peri-postnatal study in rat) toxicity Well tolerated [limited extreme high-dose effects seen (Table 3)]... 

Hass, U. Jakobsen, B.M. (1993) Prenatal toxicity of xylene inhalation in the rat A teratogenicity and postnatal study. Pharmacol. Toxicol., 73, 20-23... 

Note In case of continued maternal dosing, milk can be collected for further analysis. Parameters refer to cynomolgus monkey. Pre-/postnatal studies are considered feasible in the marmoset model (italicized parameters should be accessible in the marmoset model). 

For reproduction studies, tabulate fertility and reproductive performance studies (segment I) and perinatal and postnatal studies (segment III) if differences are observed from controls. Teratology study data (segment II) should be tabulated showing differences and similarities in gross viscera and skeletal anomalies. 

A two-generation reproduction study is needed with at least 6 hr/d exposure continuing to pups after weaning and into the F2 generation to determine the effects of long-term exposures. Developmental neurotoxicity endpoints should be included in this study based on the types of effects seen in the peri- and postnatal study with the snout-only 1 hr/d exposure. 

Figure 1 US governmental guidelines for study designs of developmental toxicity assessments in animal models, (a) FDA Segment I developmental toxicity study (b) FDA Segment III - perinatal and postnatal study (c) ERA developmental neurotoxicity study.

The complete reproductive toxicity package, including the rodent peri-and postnatal studies, must be submitted with the marketing application. 

Within the last few years emphasis has shifted from postnatal studies of acute lead intoxication to chronic low dose experimentation. Different areas of the CNS, especially the hippocampus and cerebellum, have been shown to be affected by low levels of lead exposure. 

Postnatal study groups examined cross-sectionally... 

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