Assessment of embryo/fetotoxicity and teratogenicity of azadirachtin in rats

To evaluate the potential effect of exposure to azadirachtin technical 12% throughout major organogenesis, rats were fed orally with 500, 1000 and 1500 mg/kg/day azadirachtin on gestation days 6–15 and examined for evidence of embryo/fetotoxicity and teratogenic effects. Technical azadirachtin at different doses did not produce any significant adverse effects in reproductive parameters. Significant embryo/fetotoxic effects were not observed at tested dose levels as evidenced by total number of implantations, post-implantation loss and fetal weight. There were no major malformations, while some minor variants found in high doses were not compound or dose related. The absence of anomalies in fetal gross, visceral morphology and skeleton suggests that technical azadirachtin is not teratogenic in rats at the doses tested.