Lin G H, Brusick D J
Joseph C. Wilson Center for Technology, Xerox Corporation, Webster, NY 14850.
Mutagenesis. 1986 Jul;1(4):253-9. doi: 10.1093/mutage/1.4.253.
FD&C Red No.3 (erythrosine) has been used as a dye in foods, drugs and cosmetics since its approval by the US Department of Agriculture in 1907. In 1977 the Certified Color Manufacturers' Association (CCMA) initiated studies on FD&C Red No.3 including chronic toxicity and carcinogenicity studies in rats and mice. Data from the CCMA chronic studies revealed an increased incidence of thyroid follicular cell hyperplasia and adenomas in male rats that received 4% FD&C Red No.3 in the diet (2464 mg/kg/day) during life-time (30 months) following in utero exposure. In this report, results of published studies on the mutagenicity of FD&C Red No.3 are critically reviewed. Additional mutagenicity tests including Ames Salmonella/microsome assay, L5178Y TK+/- mouse lymphoma assay, mouse micronucleus test and mitotic recombination assay with yeast Saccharomyces cerevisiae strain D5 are described. These test results together with the literature review indicate that FD&C Red No.3 can be considered non-mutagenic across several genetic endpoints including gene mutation, chromosome aberrations, primary DNA damage and cell transformation. The results of the genotoxicity assessment generally exclude FD&C Red No.3 as a genotoxic initiator and suggest that some other mechanism is responsible for the increase in tumors.
自1907年获得美国农业部批准以来，FD&C红色3号（赤藓红）一直被用作食品、药品和化妆品中的染料。1977年，认证色素制造商协会（CCMA）启动了对FD&C红色3号的研究，包括对大鼠和小鼠的慢性毒性和致癌性研究。CCMA慢性研究的数据显示，在子宫内接触后，终生（30个月）食用含4%FD&C红色3号（2464毫克/千克/天）饲料的雄性大鼠甲状腺滤泡细胞增生和腺瘤的发生率增加。在本报告中，对已发表的关于FD&C红色3号致突变性的研究结果进行了严格审查。描述了包括艾姆斯沙门氏菌/微粒体试验、L5178Y TK+/-小鼠淋巴瘤试验、小鼠微核试验和酿酒酵母菌株D5的有丝分裂重组试验在内的额外致突变性试验。这些试验结果与文献综述表明，FD&C红色3号在包括基因突变、染色体畸变、原发性DNA损伤和细胞转化在内的多个遗传终点上可被视为无致突变性。遗传毒性评估结果通常排除FD&C红色3号作为遗传毒性引发剂，并表明其他一些机制导致了肿瘤的增加。
