title: Lipid-soluble green tea extract: Genotoxicity and subchronic toxicity studies.
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.
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Dongying
authors.initials: D
authors.lastname: Liu
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Jianguo
authors.initials: J
authors.lastname: Cheng
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Song
authors.initials: S
authors.lastname: Mei
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Fu
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Weiqi
authors.initials: W
authors.lastname: Lai
authors.affiliation: Institute of Health Food, Zhejiang Academy of Medical Sciences, 182 Tian Mu Shan Road, Hangzhou 310013 China.
authors.forename: Yin
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Zhejiang Provincial Center for Disease Control and Prevention, 3399 Binsheng Road, Hangzhou 310051, China.
authors.forename: Yihong
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Intertek Scientific & Regulatory Consultancy, 2233 Argentia Rd., Suite 201, Mississauga, ON L5N 2X7 Canada.
authors.forename: Trung D
authors.initials: TD
authors.lastname: Vo
authors.affiliation: Intertek Scientific & Regulatory Consultancy, 2233 Argentia Rd., Suite 201, Mississauga, ON L5N 2X7 Canada. Electronic address: barry.lynch@intertek.com.
authors.forename: Barry S
authors.initials: BS
authors.lastname: Lynch
mesh_terms: D000818:Animals; D008055:Lipids; D051379:Mice; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000008:administration & dosage / Q000633:toxicity*; D059808:Polyphenols / Q000008:administration & dosage / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D013662:Tea / Q000737:chemistry / Q000633:toxicity*
chemical_list: D008055:Lipids; D010936:Plant Extracts; D059808:Polyphenols; D013662:Tea
keywords: Genotoxicity; Lipid soluble green tea extract; Lipid soluble tea polyphenol; Mouse sperm abnormality assay; Rat; Subchronic toxicity