Developmental toxicity organogenesis

Ema M, Kurosaka R, Amano H, Ogawa Y (1996) Comparative developmental toxicity of di-, tri- and tetrabutyltin compounds after administration during late organogenesis in rats. Journal of Applied Toxicology, 16(1) 71-76. 

Short RD, Minor JL, Ferguson B, et al. 1976. The developmental toxicity of ethylene dibromide inhaled by rats and mice during organogenesis. US Environmental Protection Agency. Washington, D.C. US Environmental Protection Agency. EPA-560/6-76-018 NTIS no. PB-256659, 11. 

Oral or dermal exposure of rats to diethanolamine during organogenesis was not associated with any sign of developmental toxicity, while inhalation exposure to diethanolamine aerosols caused signs of developmental toxicity. Dermal exposure of rabbits during organogenesis caused no sign of developmental toxicity. 

ICH 4.1.3 Assessment of Developmental Toxicity. This is almost identical to the segment II study protocol. Pregnant animals are exposed from implantation through organogenesis. The parameters measured in the segment II study are similar. However, the study is usually conducted using at least two species. More specifically, at least one rodent and one nonrodent species. 

The developmental toxicity of a 20% lipid emulsion containing a 3 1 ratio of medium-chain to long-chain triglycerides has been examined in animals. Administration was once-daily intravenously to rats and rabbits during organogenesis. Maternal and embryo/fetal toxicity were also assessed. There were no adverse effects on fetal parameters for rats even in the presence of maternal toxicity. However, embryo and fetal toxicity (resorptions) and skeletal abnormahties were noted in rabbits (135). The adverse fetal effects were probably the result of dietary deprivation, maternal toxicity, or both rather than representing a direct teratogenic effect. 

Cumene is not a primary developmental toxicant. Exposure of rats to cumene vapor during organogenesis resulted in clinical signs of maternal irritation and toxicity at 500 and 1200 ppm with a no-observed-effect level of 100 ppm. No developmental toxicity was observed at any dose level tested. Exposure of New Zealand rabbits to cumene vapor during organogenesis also resulted in clinical signs of irritation and maternal toxicity at 2300 ppm with less severe effects at 1200 and 500 ppm the noobserved-effect level was <500 ppm. No developmental toxicity was observed at any dose level tested. 

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