A 13-week subchronic toxicity study of an Eriobotrya japonica leaf extract in rats. (15th November 2018)

• Record Type: Journal Article
• Authors: Seong, Nak-Won; Seo, Heung-Sik; Kim, Jun-Ho; Kim, Yong-Jae; Kim, Eun; Lee, Joon-Yeol; Ko, Je-Won; Kim, Jong-Choon
• Is Part Of: Journal of ethnopharmacology. Volume 226(2018)
• Page Start: 1
• Page End: 10
• Publication Date: 2018-11-15
• Subjects: EJE Eriobotrya japonica leaf extract -- Hb hemoglobin concentration -- HCT hematocrit -- HPLC high-performance liquid chromatography -- MFDS Ministry of Food and Drug Safety -- OECD Organisation for Economic Cooperation and Development -- RBC red blood cell -- SD Sprague–Dawley -- WBC white blood cell; Rosaceae -- Repeated oral dose toxicity -- No-observed-adverse-effect level -- Target organ; Ethnopharmacology -- Periodicals; Pharmacognosy -- Periodicals; Herbs -- Periodicals; Herbs -- Periodicals; Pharmacognosy -- Periodicals; Pharmacognosie -- Périodiques; Herbes -- Périodiques; 615.1
• DOI: 10.1016/j.jep.2018.07.024
• Languages: English
• ISSNs: 0378-8741

Abstract

Abstract: Ethnopharmacological relevance: 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 . Aim of the study: 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. Materials and methods: Forty male and 40 female rats were randomly assigned to four experimental groups: three treatment groups receiving 250, 500, and 1000 mg/kg/day of EJE and a vehicle control group receiving sterile distilled water for 13 weeks. Results: 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. Conclusion: Under the present experimental conditions, the no-observed-adverse-effect level of EJE was > 1000 mg/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. Graphical abstract: