title: Reproductive and Developmental Toxicity of Orally Administered Botanical Composition, UP446-Part III: Effects on Fertility and Early Embryonic Development to Implantation in Sprague Dawley Rats.
abstract: In recent years, high prevalence of adverse effects associated to the use of traditional medicines during pregnancy is becoming alarming due to the self-medication of oral supplements by expecting mothers without supervision. Many expectant mothers use alternative and complementary medicines as a supplement to conventional pregnancy management with an inherent belief of considering herbal remedies as harmless. To the contrary, herbal remedies could incur a potential teratogenic risk both to the child bearing mother and the developing fetuses when consumed before or at the time of gestation. Here, we describe the potential adverse effects of orally administered UP446, a standardized bioflavonoid composition from the roots of Scutellaria baicalensis and the heartwoods of Acacia catechu, on fertility and early embryonic development to implantation in Sprague Dawley rats at doses of 250, 500, and 1000 mg/kg. Besides body weight and food consumption, reproductive functions, sperm motility and morphology, estrus cycle, and fertility rate were monitored. There were no statistically significant differences in reproductive function in all UP446 treated groups in both genders. Test substance impacts on reproductive parameters were very minimal. Neither sperm motility nor morphology was affected as a result of oral UP446 administrations in males. There were no treatment-related effects on estrus cycle stages in females. No significant changes in necropsy or histopathology were observed for all the groups. Therefore, the no observed adverse effect level (NOAEL) of UP446 was considered to be 1000 mg/kg, the highest dose tested, in both genders.
authors.affiliation: Unigen, Inc, Seattle, Washington.
authors.forename: Mesfin
authors.initials: M
authors.lastname: Yimam
authors.affiliation: Unigen, Inc, Cheonan-Si, Chungnam, Korea.
authors.forename: Young-Chul
authors.initials: YC
authors.lastname: Lee
authors.affiliation: Unigen, Inc, Cheonan-Si, Chungnam, Korea.
authors.forename: Eu-Jin
authors.initials: EJ
authors.lastname: Hyun
authors.affiliation: Unigen, Inc, Cheonan-Si, Chungnam, Korea.
authors.forename: Qi
authors.initials: Q
authors.lastname: Jia
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000473:pathology*; D000284:Administration, Oral; D000818:Animals; D000831:Animals, Newborn / Q000254:growth & development*; D001522:Behavior, Animal / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000633:toxicity; D010064:Embryo Implantation / Q000187:drug effects; D047108:Embryonic Development / Q000187:drug effects*; D005260:Female; D005298:Fertility / Q000187:drug effects; D047109:Fetal Development / Q000187:drug effects*; D008297:Male; D018811:Maternal Exposure / Q000009:adverse effects*; D009929:Organ Size / Q000187:drug effects; D010936:Plant Extracts / Q000008:administration & dosage / Q000633:toxicity*; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects; D031364:Scutellaria baicalensis; D013081:Sperm Motility / Q000187:drug effects
chemical_list: D016861:Cyclooxygenase Inhibitors; D010936:Plant Extracts; C499814:Scutellaria baicalensis extract; C574443:UP446
keywords: Acacia catechu; Scutellaria baicalensis; estrus cycle; fertility; sperm motility