Prenatal developmental toxicity study of the pyridoindole antioxidant SMe1EC2 in rats.

OBJECTIVE: The 2-ethoxycarbonyl-8-methoxy-2,3,4,4a,5,9b-hexahydro-1H-pyrido-[4,3b] indolinium chloride (SMe1EC2) is a prospective antioxidant and neuroprotectant drug. The aim of the study was to evaluate the effect of SMe1EC2 on embryofetal development of rats.

METHODS: The substance tested was administered orally to Wistar/DV rats from day 6 to day 15 of gestation at the doses 5, 50 and 250 mg/kg/day. The animals were killed on day 20 of gestation and uterine content was inspected. Live fetuses were examined for gross, skeletal and visceral anomalies.

RESULTS: Administration of SMe1EC2 did not induce any signs of maternal toxicity. No adverse effect of the substance tested was found on reproductive variables. Morphological examination of fetuses revealed no evidence of teratogenesis.

CONCLUSION: The prenatal toxicity study showed that the substance SMe1EC2 tested did not have embryotoxic and teratogenic effects on developing rats. Neither were any signs of maternal toxicity found.

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