Evaluation of the toxicological safety of erinacine A-enriched Hericium erinaceus in a 28-day oral feeding study in Sprague–Dawley rats |
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| Institution: | 1. Grape King Biotechnology Inc., Zhong-Li 320, Taiwan;2. Testing Center, Super Laboratory Inc., Taipei 24890, Taiwan;3. Department of Food Science and Biotechnology, National Chung Hsing University, Taichung 402, Taiwan;1. School of Biotechnology, Yeungnam University, Gyeongsan, Gyeongbuk 712-749, Republic of Korea;2. College of Pharmacy, Chungnam National University, Daejeon 305-764, Republic of Korea;3. College of Pharmacy, Wonkwang University, Iksan 570-749, Republic of Korea;1. School of Pharmaceutical Sciences, Central South University, Changsha, Hunan 410013, China;2. Hunan Xinhui Pharmaceutical Co., Ltd., Changsha, Hunan 410200, China;3. Department of Medicine, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, USA;1. Institute of Edible Fungi, Shanghai Academy of Agricultural Sciences, Key Laboratory of Edible Fungi Resources and Utilization (South), Ministry of Agriculture, National Engineering Research Center of Edible Fungi, Shanghai 201403, China;2. College of Life Sciences, Nanjing Agricultural University, 210095 Nanjing, China;1. Departamento de Enxeñería Química, Universidade de Vigo (Campus Ourense), Edificio Politécnico, As Lagoas, 32004 Ourense, Spain;2. Hifas da Terra SL, Portamuiños, 7, 36154 Bora, Pontevedra, Spain;1. School of Food and Biological Engineering, Jiangsu University, Zhenjiang 212013, PR China;2. National Engineering Research Center of Edible Fungi, Shanghai Academy of Agricultural Sciences, Shanghai 201403, PR China;3. Jiangxi Provincial Engineering and Technology Center for Food Additives Bio-production, Dexing 334221, PR China |
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| 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 5 mg/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 3 g/kg body weight/day. |
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| Keywords: | Erinacine A Sub-acute toxicity Safety assessment |
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