Lipid-soluble green tea extract: Genotoxicity and subchronic toxicity studies.

Lipid-soluble green tea extract: Genotoxicity and subchronic toxicity studies. Regul Toxicol Pharmacol. 2017 Apr 04;: Authors: Liu Z, Liu D, Cheng J, Mei S, Fu Y, Lai W, Wang Y, Xu Y, Vo TD, Lynch BS 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 tests. 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 20 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 concentration 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 doses tested in each case. These data provide evidence to support the safe use of LSTP in food. PMID:...
Source: Regulatory Toxicology and Pharmacology : RTP - Category: Toxicology Authors: Tags: Regul Toxicol Pharmacol Source Type: research