title: Acute and subchronic (13-week) toxicity of fermented Acanthopanax koreanum extracts in Sprague Dawley rats.
abstract: The biological fermentation of plants is usually used to improve their product properties, including their biological activity. Acanthopanax koreanum is a plant indigenous to Jeju, Korea; however, fermented A. koreanum (FAK) has not been guaranteed to be safe. Therefore, in this study, a safety evaluation of aqueous extracts of FAK was performed using Sprague Dawley rats. The acute toxicity of FAK did not influence animal mortality, body weight changes or the animals' clinical appearance at a concentration of 5000 mg/kg body weight. Using doses of 500, 1000 and 2000 mg/kg/day in a subchronic (13-week) toxicity study, the administration of FAK in male rats increased their body weight, food consumption, absolute liver weight, liver-associated enzymes and total cholesterol content. However, these effects of FAK were not considered toxic because the changes were not accompanied by any evidence of clinical signs or any change in the histopathological examination. On the other hand, the FAK-treated female rats did not exhibit significant changes in their body weight, food consumption, absolute and relative organ weights or liver enzymes. These results suggest that the acute oral administration of FAK is non-toxic to rats, and 13 weeks of repeated dosing demonstrated no FAK-related toxicity at a concentration of 2000 mg/kg. Therefore, the no-observed-adverse-effect level (NOAEL) of FAK was determined to be 2000 mg/kg/day for both male and female rats.
authors.affiliation: Department of Food Science and Biotechnology, Kangwon National University, Chuncheon 24341, Republic of Korea.
authors.forename: MyoungLae
authors.initials: M
authors.lastname: Cho
authors.affiliation: Department of Food Science and Biotechnology, Kangwon National University, Chuncheon 24341, Republic of Korea.
authors.forename: Gi-Hae
authors.initials: GH
authors.lastname: Shin
authors.affiliation: Department of Food Science and Biotechnology, Kangwon National University, Chuncheon 24341, Republic of Korea.
authors.forename: Jae-Min
authors.initials: JM
authors.lastname: Kim
authors.affiliation: Department of Food Science and Biotechnology, Kangwon National University, Chuncheon 24341, Republic of Korea.
authors.forename: Jin-Ha
authors.initials: JH
authors.lastname: Lee
authors.affiliation: STR Biotech Co., LTD, Chuncheon 24234, Republic of Korea.
authors.forename: Sun-Ok
authors.initials: SO
authors.lastname: Park
authors.affiliation: STR Biotech Co., LTD, Chuncheon 24234, Republic of Korea.
authors.forename: Sang-Jong
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul 08826, Republic of Korea.
authors.forename: HyunMu
authors.initials: H
authors.lastname: Shin
authors.affiliation: Department of Food Science and Biotechnology, CHA University, Kyonggi 13488, Republic of Korea.
authors.forename: Boo-Yong
authors.initials: BY
authors.lastname: Lee
authors.affiliation: Department of Food Science and Nutrition, Hallym University, Chuncheon 24252, Republic of Korea.
authors.forename: Il-Jun
authors.initials: IJ
authors.lastname: Kang
authors.affiliation: Department of Food Science and Biotechnology, Kangwon National University, Chuncheon 24341, Republic of Korea. Electronic address: loh99@kangwon.ac.kr.
authors.forename: Ok-Hwan
authors.initials: OH
authors.lastname: Lee
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000097:blood / Q000652:urine; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D028001:Eleutherococcus / Q000737:chemistry / Q000633:toxicity*; D005260:Female; D005285:Fermentation; D008099:Liver / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000737:chemistry / Q000633:toxicity*; D010946:Plants, Medicinal; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D012737:Sex Factors; D013997:Time Factors; D023382:Toxicity Tests, Acute / Q000379:methods*; D036401:Toxicity Tests, Chronic / Q000379:methods*; D015430:Weight Gain / Q000187:drug effects
chemical_list: D015415:Biomarkers; D010936:Plant Extracts
keywords: 13-week toxicity; Acute toxicity; Blood biochemistry; Fermented Acanthopanax koreanum; NOAEL