Borzelleca J F, Hallagan J B
Medical College of Virginia, Department of Pharmacology and Toxicology, Richmond 23298.
Food Chem Toxicol. 1988 Mar;26(3):179-87. doi: 10.1016/0278-6915(88)90117-2.
FD & C Yellow No. 5 was fed to Charles River CD rats as a dietary admixture in two long-term toxicity/carcinogenicity studies. The studies were conducted with an in utero phase in which the compound was administered to the F0 generation rats (60/sex/group) at levels of 0.0, 0.0, 0.1, 1.0 or 2.0% ('original study') and 0.0 or 5.0% ('high-dose study'). The concurrent control groups received the basal diet. After random selection of the F1 animals, the long-term phase was initiated using the same dietary levels with 70 rats of each sex/group, including the three control groups. The maximum exposure to the colouring was 113 and 114 wk for males and females, respectively, in the 'original' study and 122 and 125 wk for males and females, respectively, in the 'high-dose' study. No compound-related effects were noted. The no-adverse-effect level found in this study was 5.0% in the diet providing an average intake of 2641 and 3348 mg/kg/day for male and female rats, respectively.
在两项长期毒性/致癌性研究中，将FD&C 5号黄作为膳食添加剂喂给查尔斯河CD大鼠。研究包括子宫内阶段，在此阶段，化合物以0.0%、0.0%、0.1%、1.0%或2.0%的水平（“原研究”）以及0.0%或5.0%的水平（“高剂量研究”）给予F0代大鼠（每组60只/性别）。同期对照组给予基础饮食。在随机选择F1代动物后，长期阶段开始，每组每种性别70只大鼠采用相同的膳食水平，包括三个对照组。在“原”研究中，雄性和雌性大鼠对该色素的最大暴露时间分别为113周和114周，在“高剂量”研究中，雄性和雌性大鼠分别为122周和125周。未观察到与化合物相关的影响。本研究中发现的无不良反应水平为饮食中5.0%，雄性和雌性大鼠的平均摄入量分别为2641和3348毫克/千克/天。
