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Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel; Department of Dermatology, Hadassah Medical Center, Jerusalem, Israel.
Food Chem Toxicol. 2023 Jun;176:113734. doi: 10.1016/j.fct.2023.113734. Epub 2023 Mar 17.
In this combined chronic toxicity/carcinogenicity study of gardenia blue as a natural food color additive, Sprague Dawley rats were administered 0.5%, 2.5%, or 5.0% gardenia blue via the feed or carrier diet (0.0% gardenia blue) for 12 (chronic toxicity cohort) or 24 (carcinogenicity cohort) months. No abnormal clinical, ophthalmological, neurotoxicity or clinical pathology changes were attributed to treatment, and there was no increase in mortality due to gardenia blue exposure. The only treatment-related change was grossly observed blue discoloration of the stomach, intestines, and mesenteric lymph nodes as well as reversible dark discoloration of the kidneys all without associated histopathology. The no-observed-adverse-effect level (NOAEL) for gardenia blue exposure via the diet for one or two years was determined to be 5.0% (2175.3 mg/kg body weight/day in male rats and 3075.4 mg/kg body weight/day in female rats).
在这项栀子蓝色素作为天然食用色素的慢性毒性/致癌性联合研究中，Sprague Dawley 大鼠通过饲料或载体饮食（不含栀子蓝色素）连续 12 个月（慢性毒性队列）或 24 个月（致癌性队列）给予 0.5%、2.5%或 5.0%的栀子蓝色素。未归因于治疗的异常临床、眼科、神经毒性或临床病理学变化，也未因栀子蓝色素暴露而导致死亡率增加。唯一与治疗相关的变化是胃、肠和肠系膜淋巴结的蓝色变色，以及肾脏的可逆深褐色变色，但均无相关组织病理学变化。通过饮食摄入栀子蓝色素一年或两年的无明显不良效应水平（NOAEL）确定为 5.0%（雄性大鼠为 2175.3 mg/kg 体重/天，雌性大鼠为 3075.4 mg/kg 体重/天）。
