Teratological evaluation of gamma-glycidoxypropyltrimethoxysilane in rats.

ABSTRACT

The embryotoxic and teratogenic potential of gamma- glycidoxypropyltrimethoxysilane ( GPTS ) was evaluated in rats. Pregnant Sprague-Dawley rats were administered 0, 50, 500, or 1,000 mg/kg/day of GPTS by gavage on days 6 through 15 of gestation. No treatment related signs of toxicity, behavioral alterations or mortalities were observed in any of the pregnant animals. There was no evidence of adverse effects in mean maternal body weight, liver weight or food consumption of the treated females. The number of implantation sites, number of live fetuses per litter, the mean litter size, the sex ratio, the fetal body weight or the crown-rump length were not affected by treatment. The incidence of resorptions among the total fetal population was not altered by the administration of GPTS to pregnant rats, indicating that the test material is not embryolethal in rats at the tested dose levels. Few scattered incidences of fetal alterations in the external, soft tissue or skeletal examinations were seen both among treated and untreated litters, however, no single alteration was observed in treated litters at an incidence which was significantly different from the control. In conclusion GPTS was not embryotoxic or teratogenic in rats at dose levels up to 1000 mg/kg/day.