Reproductive and developmental toxicological evaluation of sanguinaria extract

Reproductive and developmental toxicology studies were conducted with orally administered sanguinaria extract in rats and rabbits. Groups of animals which received no test article served as controls in all studies reported. No adverse effects on estrous cycling, male or female copulatory and fertility indices or gestation/lactation parameters were observed in rats given 10-100 mg/kg/day. Reduced body weights in the offspring during lactation were observed at the 100 mg/kg/day treatment level concomitant with maternal toxicity. No developmental toxicity, including teratogenicity, was observed on the fetuses of rats following maternal administration of 5-60 mg/kg/day. An increase in post-implantation loss was observed at maternally toxic dosage levels of 50 and 75 mg/kg/day in rabbits. Oral administration of sanguinaria extract in a perinatal and postnatal study in rats caused no adverse effects on litter size, parturition, or lactation of female rats nor on survival and growth of their offspring at dosage levels of 5-60 mg/kg/day. Maternal oral toxicity thresholds were 60 mg/kg/day in rats and 25 mg/kg/day in rabbits. It was concluded that the oral intake of sanguinaria extract has no selective effect on fertility, reproduction or fetal and neonatal development in rats or rabbits.