LIFETIME TOXICITY CARCINOGENICITY STUDIES OF FD-AND-C BLUE NO-1 (BRILLIANT BLUE FCF) IN RATS AND MICE
LIFETIME TOXICITY CARCINOGENICITY STUDIES OF FD-AND-C BLUE NO-1 (BRILLIANT BLUE FCF) IN RATS AND MICE
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DOI：
10.1016/0278-6915(90)90034-k
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发表时间：
1990-04-01
影响因子：
4.3
通讯作者：
HALLAGAN, JB
中科院分区：
文献类型：
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作者：
BORZELLECA, JF;DEPUKAT, K;HALLAGAN, JB
在终生毒性/致癌性研究中，将FD和C蓝1号作为饲料混合物饲喂Charles River CD大鼠和CD-1小鼠。在子宫内阶段进行大鼠研究，其中以0.0%、0.0%、0.1%、1.0%或2.0%的饲料浓度向F0代大鼠（60只/性别/组）给予化合物。随机选择F1动物后，以相同水平开始寿命期，每组70只大鼠/性别，包括两个对照组。雄性和雌性的最大接触时间分别为116周和111周。基于与合并对照组相比，高剂量组雌性动物终末体重降低15.0%和存活率降低，雄性动物（1072 mg/kg体重/天）和雌性动物（631 mg/kg/天）的无明显不良作用水平分别为2.0%和1.0%的饮食浓度。在一项终生毒性/致癌性研究中，以0.0%、0.0%、0.5%、1.5%或5.0%的饲料混合物形式饲喂Charles River CD-1小鼠（60只/性别/组）FD和C蓝1号。雄性和雌性的最大暴露时间均为104周。未观察到一致、显著的化合物相关不良反应。本研究中确定的无明显不良作用水平为5.0%的饮食浓度（雄性和雌性小鼠分别为7354 mg/kg/天和8966 mg/kg/天）。
FD and C Blue No. 1 was fed to Charles River CD rats and CD-1 mice as a dietary admixture in lifetime toxicity/carcinogenicity studies. The rat study was conducted with an in utero phase in which the compound was administered to the F0 generation rats (60/sex/group) at dietary concentrations of 0.0%, 0.0%, 0.1%, 1.0% or 2.0%. After randomly selecting the F1 animals, the lifetime phase was initiated at the same levels with 70 rats/sex/group, including two control groups. The maximum exposure times were 116 and 111 wk for males and females, respectively. The no-observed-adverse-effect levels are dietary concentrations of 2.0% for males (1072 mg/kg body weight/day), and 1.0% for females (631 mg/kg/day) based on a 15.0% decrease in terminal body weight and decreased survival in the high-dose females compared with the combined control groups. Charles River CD-1 mice (60/sex/group) were fed FD and C Blue No. 1 as a dietary admixture at levels of 0.0%, 0.0%, 0.5%, 1.5% or 5.0% in a lifetime toxicity/carcinogenicity study. The maximum exposure time was 104 wk for both males and females. No consistent, significant compound-related adverse effects were noted. The no-observed-adverse-effect level established in this study is a dietary concentration of 5.0% (7354 mg/kg/day and 8966 mg/kg/day for male and female mice, respectively).