Ogasawara H, Todate A, Onodera H, Matsushima Y, Shibutani M, Yoshida J, Maekawa A, Hayashi Y
Eisei Shikenjo Hokoku. 1990(108):84-9.
A 13-week subchronic oral toxicity study of tannic acid (TA) was carried out in F344 rats at dose levels of 0, 0.025, 0.05, 0.1, 0.2 and 0.4% in the drinking water, to determine appropriate dose levels for a subsequent 2-year carcinogenicity study. The rats were randomly allocated to 6 groups, each consisting of 12 males and 12 females. No animals died during the administration period. There were no significant difference in body weight gain, food consumption and organ weights between the treated and control groups, although a slight decrease in water intake was seen in the 0.4% TA treated group. No specific changes were observed in any parameters in the hematological and biochemical investigations. Histopathological examination, revealed toxic changes in the TA treated male groups, in the form of necrosis in the liver, but toxicologically it was of minor importance. From these results, it was concluded that the provable maximum tolerable dose of TA in the drinking water would be more than 0.4%. In consideration of the avoidance of drinking water, the maximum tolerable dose of tannic acid was determined to be 0.5%, when given in the drinking water.
在F344大鼠中开展了一项为期13周的单宁酸(TA)亚慢性经口毒性研究,饮用水中的TA剂量水平分别为0%、0.025%、0.05%、0.1%、0.2%和0.4%,以确定后续两年致癌性研究的合适剂量水平。大鼠被随机分为6组,每组由12只雄性和12只雌性大鼠组成。给药期间无动物死亡。虽然在0.4%TA处理组中观察到水摄入量略有下降,但处理组和对照组之间在体重增加、食物消耗和器官重量方面无显著差异。血液学和生化检查的任何参数均未观察到特定变化。组织病理学检查显示,TA处理的雄性组出现毒性变化,表现为肝脏坏死,但从毒理学角度来看,其重要性较小。根据这些结果,得出结论,饮用水中单宁酸的可证明最大耐受剂量将超过0.4%。考虑到避免饮用含TA的水,当通过饮用水给药时,单宁酸的最大耐受剂量确定为0.5%。