Safety assessment of heat-sterilized green tea catechin preparation: a 6-month repeat-dose study in rats

Food Chem Toxicol. 2009 Aug;47(8):1760-70. doi: 10.1016/j.fct.2009.04.033. Epub 2009 May 3.

Abstract

Evidence suggests that the purported health benefits associated with green tea consumption are related to tea catechins. In the present study, potential adverse effects of a standardized heat-sterilized green tea catechin (GTC-H) preparation was investigated following gavage administration to rats at doses of 0, 120, 400, 1200 mg/kg/day for 6 months. A decaffeinated high-dose group (1200 mg/kg/day) (GTC-HDC), was included for comparison. A possibly test article-related clinical finding of intermittent increased activity was noted in the 400 and 1200 mg/kg/day GTC-H groups, but was not considered to be adverse. Lower body weight gains without any decrease in food consumption were noted in the high-dose (1200 mg/kg/day)-treated GTC-H and GTC-HDC females. In the high-dose male GTC-H group, a lower total motor activity count for the 60-min session was noted prior to dosing at the study week 25 evaluations compared to the control group. Similar changes were not observed in the GTC-HDC group. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for GTC-H was 1200 mg/kg/day for males, the highest dose tested, and 400mg/kg/day for females based on reduced body weight gains. The NOAEL for GTC-HDC was 1200 mg/kg/day for males and could not be determined in females.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Behavior, Animal / drug effects
  • Blood Cell Count
  • Blood Chemical Analysis
  • Body Weight / drug effects
  • Caffeine / chemistry
  • Caffeine / toxicity
  • Catechin / chemistry
  • Catechin / toxicity*
  • Dose-Response Relationship, Drug
  • Eating / drug effects
  • Eye / pathology
  • Female
  • Hot Temperature
  • Male
  • Motor Activity / drug effects
  • Rats
  • Rats, Sprague-Dawley
  • Sex Characteristics
  • Stereoisomerism
  • Sterilization*
  • Survival Analysis
  • Tea / chemistry
  • Tea / toxicity*
  • Urinalysis

Substances

  • Tea
  • Caffeine
  • Catechin