Kanki Keita, Nishikawa Akiyoshi, Furukawa Fumio, Kitamura Yasuki, Imazawa Takayoshi, Umemura Takashi, Hirose Masao
Division of Pathology, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, 158-8501 Tokyo, Japan.
Food Chem Toxicol. 2003 Oct;41(10):1337-43. doi: 10.1016/s0278-6915(03)00136-4.
The fruit of the paprika (Capsicum annuum) has been widely used in various countries as a spice and food-coloring additive. As a part of the safety assessment of paprika color (Paprika oleoresin), a 13-week subchronic toxicity study was performed in F344 rats. To establish a no-observed-adverse-effect level (NOAEL) for application in subsequent long-term studies, rats were fed powder diet containing paprika color at dose levels of 0 (basal diet), 0.62, 1.25, 2.5 and 5% (maximum) for 13 weeks. During the experiment, there were no remarkable changes in general appearance and no deaths occurred in any experimental group. Although serum total cholesterol was dose-dependently increased in both sexes, no related histopathological changes were observed in the liver. Slight inflammatory cell infiltration in the myocardium and vacuolation of hepatocytes were noted in both control and paprika color-treated animals, but there were no clear differences between groups. In conclusion, paprika color even at 5% in the diet (0.67 g/rat/day or 2948.4 mg/kg bw/day for male rats and 0.43 g/rat/day or 3197.4 mg/kg bw/day for female rats) did not cause remarkable adverse effects in F344 rats. Thus, the NOAEL and the maximum dose level for carcinogenicity testing of paprika color were concluded to be 5% in the diet.
辣椒（辣椒属）果实已在各国广泛用作香料和食品着色添加剂。作为辣椒色素（辣椒提取物）安全性评估的一部分，在F344大鼠中进行了为期13周的亚慢性毒性研究。为了确定在后续长期研究中应用的未观察到有害作用水平（NOAEL），给大鼠喂食含辣椒色素剂量水平为0（基础日粮）、0.62%、1.25%、2.5%和5%（最大剂量）的粉状日粮，持续13周。在实验期间，一般外观无明显变化，任何实验组均未出现死亡。虽然两性血清总胆固醇均呈剂量依赖性升高，但肝脏未观察到相关的组织病理学变化。在对照组和经辣椒色素处理的动物中均观察到心肌有轻微炎症细胞浸润和肝细胞空泡化，但两组之间无明显差异。总之，日粮中5%的辣椒色素（雄性大鼠为0.67 g/大鼠/天或2948.4 mg/kg体重/天，雌性大鼠为0.43 g/大鼠/天或3197.4 mg/kg体重/天）对F344大鼠未产生明显的不良影响。因此，得出辣椒色素致癌性试验的NOAEL和最大剂量水平为日粮中的5%。
