Nabae Kyoko, Hayashi Shim-Mo, Kawabe Mayumi, Ichihara Toshio, Hagiwara Akihiro, Tamano Seiko, Tsushima Yoko, Uchida Koji, Koda Takatoshi, Nakamura Mikio, Ogawa Kumiko, Shirai Tomoyuki
DIMS Institute of Medical Science, Inc., 64 Goura, Nishiazai, Azai-cho, Ichinomiya 491-0113, Japan.
Food Chem Toxicol. 2008 Feb;46(2):774-80. doi: 10.1016/j.fct.2007.10.004. Epub 2007 Oct 10.
A subchronic oral toxicity study of purple corn color (PCC), a natural food colorant, was performed with groups of 10 male and 10 female F344 rats fed the agent at dietary levels of 0%, 0.5%, 1.5% and 5.0% for 90 days. No mortalities occurred during the treatment period. No treatment-related changes in the body weight, food and water consumption, ophthalmology, hematology, organ weight data and histopathology were observed. Regarding general conditions and gross pathology, staining of fur and black feces were noted in rats of the 1.5% and 5.0% diet groups. Moreover, brown urine and black material in the stomach, small and large intestine were evident in rats receiving 5.0%. These changes were considered due to the anthocyanin content. On clinical chemistry analysis, total cholesterol, phospholipid and triglyceride were significantly lowered in both sexes of the 5.0% group, but these were not considered to be toxicologically significant. Thus, the No-observed-adverse-effect-level (NOAEL) was judged to be 5.0% in diet for both sexes (male: 3542 mg/kg/day, female: 3849 mg/kg/day) for PCC under the present experimental conditions.
对天然食用色素紫玉米色素（PCC）进行了亚慢性经口毒性研究，将10只雄性和10只雌性F344大鼠分为几组，分别喂食含0%、0.5%、1.5%和5.0%该受试物的饲料，持续90天。治疗期间未发生死亡。未观察到与治疗相关的体重、食物和水消耗、眼科、血液学、器官重量数据及组织病理学变化。关于一般状况和大体病理学，在饮食中含1.5%和5.0%受试物的大鼠组中，观察到毛发染色和黑色粪便。此外，摄入5.0%受试物的大鼠中，可见棕色尿液以及胃、小肠和大肠中有黑色物质。这些变化被认为是由于花青素含量所致。临床化学分析显示，5.0%受试物组的雌雄两性总胆固醇、磷脂和甘油三酯均显著降低，但这些变化在毒理学上不被认为具有显著意义。因此，在本实验条件下，PCC对雌雄两性的未观察到有害作用水平（NOAEL）判定为饮食中5.0%（雄性：3542毫克/千克/天，雌性：3849毫克/千克/天）。
