Reproductive and Developmental Toxicity of Orally Administered Botanical Composition,UP446‐Part I: Effects on Embryo‐Fetal Development in New Zealand White Rabbits and Sprague Dawley Rats

The pharmacotoxicology impacts of dietary supplements taken at the time of pregnancy have remained alarming since women are the frequent herbal medicine users in many countries as a complement to the conventional pregnancy management. The use of herbal medicines and diet supplements in expectant mothers linked closely to the health of the childbearing mothers and the fetuses where the lack of developmental safety data imposes a challenge to make the right choices. 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 embryo‐fetal development following maternal exposure during the critical period of major organogenesis in rabbits and rats. Pregnant dams were treated orally with UP446 at doses of 250, 500, and 1000 mg/kg/day during gestation. The number of resorptions, implantations, litter size, body weights, and skeletal development was evaluated. Maternal food intake and body, tissue, and placenta weight were also assessed. There were no statistically significant differences in implantation, congenital malformation, embryo‐fetal mortalities, and fetuses sex ratios in all dosing groups of both species. Therefore, the no observed adverse effect level of UP446 was considered to be greater than 1000 mg/kg in both the maternal and fetus in both species     

Reproductive and Developmental Toxicity of Orally Administered Botanical Composition,UP446‐Part II: Effects on Prenatal and Postnatal Development,Including Maternal Function in Sprague–Dawley Rats

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