Abstract
Synthetic amorphous silica is a nanostructured material, which is produced and used in a wide variety of technological applications and consumer products. No regulatory prenatal toxicity studies with this substance were reported yet. Therefore, synthetic amorphous silica was tested for prenatal toxicity, according to OECD guideline 414 in Wistar rats following oral (gavage) administration at the dose levels 0, 100, 300, or 1000 mg/kg bw/d from gestation day 6–19. At gestation day 20, all pregnant animals were examined by cesarean section. Numbers of corpora lutea, implantations, resorptions, live and dead fetuses were counted. Fetal and placental weights were determined. Fetuses were examined for external, visceral and skeletal abnormalities. No maternal toxicity was observed at any dose level. Likewise, administration of the test compound did not alter cesarean section parameters and did not influence fetal or placental weights. No compound-related increase in the incidence of malformations or variations was observed in the fetuses. The no observed adverse effect level (NOAEL) was 1000 mg/kg bw/d.
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