title: Evaluation of the toxicological safety of erinacine A-enriched Hericium erinaceus in a 28-day oral feeding study in Sprague-Dawley rats.
abstract: Natural products have attained great importance as they are believed to be the new alternative medicines for conventional therapy. As numerous studies have proved the tremendous medicinal values of Hericium erinaceus, it is necessary to take into account its safety as well as its risk for the recipient. However, mushroom mycelium has an identity distinct from mushrooms, as two specific classes of compounds, hericenones and erinacines, can only be extracted from both the fruit body and the cultured mycelium, respectively. Therefore, this is the first report on the evaluation of the toxicity of H.erinaceus mycelium, enriched with 5mg/g erinacine A, by a 28-day repeated oral administration study in Sprague-Dawley rats. Three doses of 1 (Low), 2 (Mid) and 3 (High) g/kg body weight/day were selected for the study while distilled water served as control. All animals survived to the end of the study. No abnormal changes were observed in clinical signs. No adverse or test article-related differences were found in urinalysis, haematology and serum biochemistry parameters, between the treatment and control groups. No gross pathological findings and histopathological differences were seen. Therefore, the no-observed-adverse-effect level of erinacine A-enriched H.erinaceus is greater than 3g/kgbody weight/day.
authors.affiliation: Grape King Biotechnology Inc., Zhong-Li 320, Taiwan. Electronic address: ichen.li@grapeking.com.tw.
authors.forename: I-Chen
authors.initials: IC
authors.lastname: Li
authors.affiliation: Grape King Biotechnology Inc., Zhong-Li 320, Taiwan. Electronic address: lan.chen@grapeking.com.tw.
authors.forename: Yen-Lien
authors.initials: YL
authors.lastname: Chen
authors.affiliation: Grape King Biotechnology Inc., Zhong-Li 320, Taiwan. Electronic address: ly.lee@grapeking.com.tw.
authors.forename: Li-Ya
authors.initials: LY
authors.lastname: Lee
authors.affiliation: Grape King Biotechnology Inc., Zhong-Li 320, Taiwan. Electronic address: wp.chen@grapeking.com.tw.
authors.forename: Wan-Ping
authors.initials: WP
authors.lastname: Chen
authors.affiliation: Testing Center, Super Laboratory Inc., Taipei 24890, Taiwan. Electronic address: r91445202@gmail.com.
authors.forename: Yueh-Ting
authors.initials: YT
authors.lastname: Tsai
authors.affiliation: Grape King Biotechnology Inc., Zhong-Li 320, Taiwan. Electronic address: gkbioeng@grapeking.com.tw.
authors.forename: Chin-Chu
authors.initials: CC
authors.lastname: Chen
authors.affiliation: Department of Food Science and Biotechnology, National Chung Hsing University, Taichung 402, Taiwan. Electronic address: cschen@mail.nchu.edu.tw.
authors.forename: Chin-Shuh
authors.initials: CS
authors.lastname: Chen
mesh_terms: D000284:Administration, Oral; D000363:Agaricales / Q000737:chemistry*; D000818:Animals; D001487:Basidiomycota / Q000737:chemistry*; D004224:Diterpenes / Q000737:chemistry* / Q000633:toxicity; D004305:Dose-Response Relationship, Drug; D005260:Female; D008297:Male; D025282:Mycelium / Q000737:chemistry; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D004224:Diterpenes; C000595639:erinacine A
keywords: Erinacine A; Hericium erinaceus; Safety assessment; Sub-acute toxicity