Reproductive, teratologic, and mutagenic studies with some polydimethylsiloxanes

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Abstract
The purpose of these studies was to evaluate the effects of selected polydimethylsiloxanes on reproduction and fetal development in rats and rabbits and to determine the mutagenic potential of 1 such material in mice. In 2 separate 3-phase studies in rats and rabbits with a 350 centistoke [cs] medical grade fluid, the only significant effect noted was an apparent dose-related incidence of in utero mortality at dose levels of 200 and 1000 mg/kg s.c. in rats in 1 study. No evidence of fetotoxicity was obtained in the 2nd study at the same dose levels. The incidence of talipes varus at a s.c. dose level of 200 mg/kg in rabbits (8.8%) is at or above that expected for control populations. The nonoccurrence of talipes varus at the higher level of 1000 mg/kg and the absence of this defect in the companion study casts doubt on the significance of this finding. A 7-cs pump fluid was nonteratogenic in rats at oral doses as high as 1000 mg/kg and was nonmutagenic in male mice at i.p. doses of 5 and 10 g/kg. A 10-cs fluid was nonteratogenic in rabbits at a dermal dose level of 200 mg/kg.