Teratogenicity and in vitro mutagenicity studies on nonoxynol-9 and -30.

Polyoxyethylene alkylphenols (PA) are a group of non-ionic surfactants with a widespread use. As part of the safety evaluation of PA a teratology study with nonoxynol-9 and -30 (NP-9 and NP-30) administered perorally and epicutaneously to rats was performed. In addition the mutagenicity of NP-9 was tested in the Ames test. Treatment of pregnant rats with NP-30 (up to 1 g/kg b.wt./day, orally) did not reveal any signs of adverse effects. Pregnant rats given 250 mg or 500 mg NP-9/kg b.wt./day orally exhibited a statistically significant decrease in weight gain. A concomitant effect in these dams on reproduction, and an increase in the incidence of extra ribs and dilated pelvic cavity in their foetuses was interpreted as a consequence of a toxic effect of high doses of NP-9. No clear cut effect was observed when pregnant rats were dosed epicutaneously with up to 500 mg of NP-9/kg b.wt./day. A slight but persistent response in one tester strain in the Ames test was not interpreted as a clear mutagenic effect of NP-9.