| Institution: | 1. Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China;2. Zhejiang Provincial Center for Disease Control and Prevention, 3399 Binsheng Road, Hangzhou 310051, China;3. Intertek Scientific & Regulatory Consultancy, 2233 Argentia Rd., Suite 201, Mississauga, ON L5N 2X7 Canada;1. School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, 264005, PR China;2. School of Life Sciences, Yantai University, Yantai, 264005, PR China;1. Laboratoire de Biologie des Ligneux et des Grandes Cultures, EA1207, Université d’Orléans, Orléans, France;2. Institut de Chimie Organique et Analytique, UMR7311, Université d’Orléans-CNRS, Orléans, France;3. Centre de Biophysique Moléculaire, UPR4301, CNRS-Université d’Orléans, Orléans, France;4. Department of Pharmaceutical Biology, University of Groningen, Groningen, The Netherlands;5. Service de Transformations Chimiques et Pharmaceutiques, ERL CNRS 3193, Le CNAM, Paris, France;6. Ecole SITI, Département CASER, Le CNAM, Paris, France;1. Department of Anatomy, Southern Illinois University School of Medicine, Carbondale, IL 62901, USA;2. Center for Integrated Research and Cognitive Neural Science, Southern Illinois University School of Medicine, Carbondale, IL 62901, USA;3. Molecular, Cellular and Systemic Physiology Undergraduate Program, Southern Illinois University, Carbondale, IL 62901, USA |
| Abstract: | To assess the potential safety of lipid soluble green tea extract, also referred to as lipid soluble tea polyphenols (LSTP), a series of genotoxicity tests were conducted, including an Ames, in vivo mouse micronucleus, and in vivo mouse sperm abnormality test. The toxicity of LSTP was evaluated in 90- and 30-day feeding studies. LSTP did not show mutagenic activity in the Ames test and no genotoxic potential in the in vivo assays at doses up to 10 g/kg body weight (bw). In the 90-day feeding study, LSTP was given in the diet at levels providing 0, 0.125, 0.25, or 0.50 g/kg bw/day. No significant effects were noted on body weight, food consumption, hematology, clinical chemistry, organ weights, and histopathological examination. The no-observed-adverse-effect level (NOAEL) was therefore considered to be 0.50 g/kg bw/day, the highest dose tested. Likewise, dosing of SD rats by gavage for 30 days also showed no adverse effects of growth, hematology, clinical chemistry, organ weights, or histopathology at doses of 0.58, 1.17, and 2.33 g/kg bw/day. The NOAEL in the 30-day study was considered to be the highest dose tested. These data provide evidence to support the safe use of LSTP in food. |
