Reproductive and Developmental Toxicity of Orally Administered Botanical Composition, UP446-Part II: Effects on...

Almost all herbal remedies could be therapeutic at one dose and toxic at another. These facts become more troubling and a double threat when uncharacterized medicinal herbs are blended together and used by expectant mothers as a supplement to conventional pregnancy management with an inherent belief of considering herbal remedies as harmless. Here we describe the potential adverse effects of UP446, a standardized bioflavonoid composition from the roots of Scutellaria baicalensis and the heartwoods of Acacia catechu, on the maternal and their first filial generation (F1) developmental and functional toxicity following exposure at doses of 250, 500, and 1000 mg/kg/day. Maternal gestation, viability index, sex ratio, body weight, and food consumption were evaluated. F1 growth and development, sexual function including mating index, fertility, implantation, and embryo mortality were also assessed. Test substance impacts on the maternal (F0) or F1 reproductive parameters were very minimal. There were no statistically significant differences in implantation, parturition, viability, and neonates' sex ratios. There were no significant changes in maturation, behavioral, or functional developments between groups. No treatment-related prenatal or postnatal in-life or necropsy abnormalities were observed. Therefore, the no observed adverse effect level in the prenatal and postnatal developments, including maternal function study was considered to be greater than 1000 mg/kg.