Maekawa A, Matsuoka C, Onodera H, Tanigawa H, Furuta K, Kanno J, Jang J J, Hayashi Y, Ogiu T
Division of Pathology, National Institute of Hygienic Sciences, Tokyo, Japan.
Food Chem Toxicol. 1987 Dec;25(12):891-6. doi: 10.1016/0278-6915(87)90281-x.
The carcinogenicity of tartrazine (C. I. Food Yellow No. 4, FD & C Yellow No. 5), a food, drug and cosmetics colouring, was examined in F344 rats. Tartrazine was dissolved in distilled water at levels of 0, 1 or 2%, and groups of about 50 male and 50 female rats were given one of these solutions ad lib. as their drinking-water for up to 2 yr. No toxic lesions specifically caused by tartrazine were detected in any treated group of either sex. Many tumours developed in all groups including the control group, and the organ distribution of these tumours and their histological characteristics were similar to those of the spontaneous tumours that are known to occur in this strain of rats. Except for mesothelioma in males and endometrial stromal polyp in females, there were no significant increases in the incidences of any tumours over those in the corresponding control group. In males, mesotheliomas were found only in the group given 1% tartrazine and the incidence of this lesion was statistically significant (Fisher's exact test) in comparison with the other two groups (P less than 0.02). The incidence of endometrial stromal polyp was also significantly higher among females given the 1% dose than in the controls (P less than 0.05). However, no positive trend was noted in the occurrence of these two tumours using an age-adjusted statistical analysis. Mesothelioma and endometrial stromal polyp are frequently observed spontaneous tumours in this strain of rats, and their incidences in our historical controls are 4.1 and 21.9%, respectively. However in the present study mesothelioma occurred in none of the male control rats and the incidence of endometrial stromal polyp was only 10.6% in the female control group. Moreover, there was no significant difference between the control and treated groups in hyperplastic or pre-neoplastic changes in the mesothelium or endometrium. From these findings, we concluded that the significant increases in the incidences of mesothelioma and endometrial stromal polyp that occurred in the groups given 1% tartrazine were not attributable to tartrazine administration. Thus, it is concluded that tartrazine was not carcinogenic in F344 rats when administered continuously at doses of up to 2% in the drinking-water for up to 2 yr.
柠檬黄（C.I.食用黄4号，FD&C黄5号）是一种用于食品、药品和化妆品的色素，对F344大鼠的致癌性进行了研究。将柠檬黄以0%、1%或2%的浓度溶解于蒸馏水中，每组约50只雄性和50只雌性大鼠自由饮用其中一种溶液作为饮用水，持续2年。在任何处理组的雌雄大鼠中均未检测到由柠檬黄特异性引起的毒性损伤。所有组包括对照组都出现了许多肿瘤，这些肿瘤的器官分布及其组织学特征与已知在该品系大鼠中发生的自发肿瘤相似。除了雄性的间皮瘤和雌性的子宫内膜间质息肉外，任何肿瘤的发生率与相应对照组相比均无显著增加。在雄性中，间皮瘤仅在给予1%柠檬黄的组中发现，与其他两组相比，该病变的发生率具有统计学意义（Fisher精确检验）（P小于0.02）。给予1%剂量的雌性大鼠中子宫内膜间质息肉的发生率也显著高于对照组（P小于0.05）。然而，使用年龄调整的统计分析，在这两种肿瘤的发生中未发现阳性趋势。间皮瘤和子宫内膜间质息肉是该品系大鼠中常见的自发肿瘤，在我们的历史对照组中其发生率分别为4.1%和21.9%。然而，在本研究中，雄性对照大鼠中未出现间皮瘤，雌性对照组中子宫内膜间质息肉的发生率仅为10.6%。此外，对照组和处理组之间在间皮或子宫内膜的增生性或癌前病变方面没有显著差异。根据这些发现，我们得出结论，给予1%柠檬黄的组中间皮瘤和子宫内膜间质息肉发生率的显著增加并非归因于柠檬黄的给药。因此，得出结论，当以高达2%的剂量在饮用水中连续给予F344大鼠长达2年时，柠檬黄不具有致癌性。
