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A 13-week subchronic toxicity study of an Eriobotrya japonica leaf extract in rats

Seong, Nak-Won, Seo, Heung-Sik, Kim, Jun-Ho, Kim, Yong-Jae, Kim, Eun, Lee, Joon-Yeol, Ko, Je-Won, Kim, Jong-Choon
Journal of ethnopharmacology 2018
Eriobotrya japonica, adverse effects, antineoplastic activity, antioxidants, blood chemistry, dose response, females, hematology, histopathology, leaf extracts, leaves, males, necropsy, no observed adverse effect level, ophthalmology, oral administration, rats, signs and symptoms (animals and humans), subchronic toxicity, tissue weight, traditional medicine, urinalysis
Eriobotrya japonica leaf is widely used in traditional medicine, and exhibits various beneficial effects such as anti-inflammatory, antiviral, antioxidant, and antitumor activities. However, limited data are available on the potential adverse effects of E. japonica.This study investigated the potential subchronic toxicity of an E. japonica leaf extract (EJE) through a 13-week repeated oral dose experiment in Sprague–Dawley rats.Forty male and 40 female rats were randomly assigned to four experimental groups: three treatment groups receiving 250, 500, and 1000mg/kg/day of EJE and a vehicle control group receiving sterile distilled water for 13 weeks.Repeated oral administration of EJE for 13 weeks did not cause any treatment-related adverse effects with respect to clinical symptoms, body weight, food and water consumption, urinalysis, ophthalmology, necropsy findings, hematology, serum biochemistry, organ weight, and histopathological examination at any dose tested. Although some changes were observed in clinical symptoms, organ weight, hematology, and histopathology, these findings did not show a dose–response relationship and were within normal historical ranges for control rats.Under the present experimental conditions, the no-observed-adverse-effect level of EJE was >1000mg/kg/day in both sexes and no target organs were identified. The results suggest that the EJE is a safe traditional medicine for clinical applications at proper dose.