Imazawa T, Nishikawa A, Furukawa F, Tanakamaru Z, Lee I S, Kim H C, Takahashi M
Eisei Shikenjo Hokoku. 1996(114):27-32.
A 13-week oral toxicity study of gardenia blue was performed in male and female F344 rats at the dose levels of 5.0, 2.5, 1.25, 0.6 and 0% in the diet, to determine the maximum tolerable dose (MTD) for subsequent investigation of carcinogenicity. Rats were randomly allocated to 5 groups, each consisting of 10 males and 10 females. No groups showed decreases in body weight gain and food intake, and all animals survived until the end of the experiment. A dose-dependent decrease in number of platelets was observed in females treated with gardenia blue in hematological examination, but not in males. No histopathological change, relating to the treatment, in megakaryocyte which is the progenitor cell of platelets was observed in the treated-females. Serum biochemistry revealed increases in GOT and GPT in both sexes treated with the 5.0% and 2.5% gardenia blue, as compared to the control value. However, these were not considered to be specific changes because of lack of any clear dose response. In addition, no histopathological changes indicating obvious toxicity of gardenia blue were observed in the liver of both sexes treated with gardenia blue. Based on these data, the MTD of gardenia blue for both sexes in F344 rats was considered to be 5.0% or more in the diet.
对雄性和雌性F344大鼠进行了一项为期13周的栀子蓝口服毒性研究，饲料中栀子蓝的剂量水平分别为5.0%、2.5%、1.25%、0.6%和0%，以确定最大耐受剂量（MTD），用于后续致癌性研究。大鼠被随机分为5组，每组由10只雄性和10只雌性组成。没有组出现体重增加和食物摄入量下降的情况，所有动物都存活到实验结束。血液学检查中，用栀子蓝处理的雌性大鼠血小板数量呈剂量依赖性下降，但雄性大鼠未出现这种情况。在接受处理的雌性大鼠中，未观察到与处理相关的血小板祖细胞巨核细胞的组织病理学变化。血清生化检查显示，与对照组相比，饲料中含5.0%和2.5%栀子蓝处理的雌雄大鼠谷草转氨酶（GOT）和谷丙转氨酶（GPT）均升高。然而，由于缺乏明确的剂量反应，这些变化不被认为是特异性变化。此外，在接受栀子蓝处理的雌雄大鼠肝脏中，未观察到表明栀子蓝有明显毒性的组织病理学变化。基于这些数据，F344大鼠雌雄两性栀子蓝的最大耐受剂量被认为是饲料中5.0%或更高。
