title: Mutagenicity and oral toxicity studies of Terminalia chebula.
abstract: The fruit of Terminalia chebula Retz. (T. chebula), which is a member of the Combfreetaceae family, is used widely in Asian countries as a traditional folk medicine, and its extract has been reported to be an anticancer, antidiabetic and anticaries agent. In our previous study, chebulic acid isolated from T. chebula extract was confirmed to show antioxidant activity and protective action against endothelial cell dysfunction. In order to support the safety-in-use of the ethyl acetate (EtOAc)-soluble portion of a T. chebula ethanol extract containing 29.4% chebulic acid content, the prepared portion was tested in an in vitro mutagenicity assay, and a single- and 14-day repeated dose oral toxicity study. In the bacterial mutation assay, up to 5000 µg/mL concentration of the EtOAc-soluble portion, the numbers of colonies did not increase whether with or without metabolic activation. In the oral toxicity study, the single oral dose of the extract at 2000 mg/kg did not produce mortality or abnormal lesions in the internal organs of rats. The results of a 14-day orally repeated dose showed that the EtOAc-soluble portion of T. chebula ethanol extracts gave no adverse effects at dosages of 2000 mg/kg in rats in the study.
authors.affiliation: Department of Food Bioscience and Technology, College of Life Sciences and Biotechnology, Korea University, Seoul 136-701, Republic of Korea.
authors.forename: Ji-hoon
authors.initials: JH
authors.lastname: Kim
authors.forename: Yun-chang
authors.initials: YC
authors.lastname: Koo
authors.forename: Chung-Oui
authors.initials: CO
authors.lastname: Hong
authors.forename: Sung-Yong
authors.initials: SY
authors.lastname: Yang
authors.forename: Woojin
authors.initials: W
authors.lastname: Jun
authors.forename: Kwang-Won
authors.initials: KW
authors.lastname: Lee
mesh_terms: D000818:Animals; D001419:Bacteria / Q000187:drug effects / Q000235:genetics; D001578:Benzopyrans / Q000009:adverse effects*; D015169:Colony Count, Microbial; D003643:Death; D005260:Female; D005638:Fruit; D008297:Male; D016296:Mutagenesis; D009152:Mutagenicity Tests; D009153:Mutagens / Q000633:toxicity; D010936:Plant Extracts / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D029766:Terminalia / Q000737:chemistry / Q000633:toxicity*
chemical_list: D001578:Benzopyrans; D009153:Mutagens; D010936:Plant Extracts; C572649:chebulic acid