Division of Biochemical Toxicology, Food and Drug Administration, Jefferson, Arkansas 72079, USA.
Toxicol Sci. 2013 Jan;131(1):26-39. doi: 10.1093/toxsci/kfs275. Epub 2012 Sep 11.
Aloe barbadensis Miller (Aloe vera) is an herbal remedy promoted to treat a variety of illnesses; however, only limited data are available on the safety of this dietary supplement. Drinking water exposure of F344/N rats and B6C3F1 mice to an Aloe vera whole-leaf extract (1, 2, and 3%) for 13 weeks resulted in goblet cell hyperplasia of the large intestine in both species. Based upon this observation, 2-year drinking water studies were conducted to assess the carcinogenic potential of an Aloe vera whole-leaf extract when administered to F344/N rats (48 per sex per group) at 0.5, 1, and 1.5%, and B6C3F1 mice (48 per sex per group) at 1, 2, and 3%. Compared with controls, survival was decreased in the 1.5% dose group of female rats. Treatment-related neoplasms and nonneoplastic lesions in both species were confined primarily to the large intestine. Incidences of adenomas and/or carcinomas of the ileo-cecal and cecal-colic junction, cecum, and ascending and transverse colon were significantly higher than controls in male and female rats in the 1 and 1.5% dose groups. There were no neoplasms of the large intestine in mice or in the 0 or 0.5% dose groups of rats. Increased incidences of mucosa hyperplasia of the large intestine were observed in F344/N rats, and increased incidences of goblet cell hyperplasia of the large intestine occurred in B6C3F1 mice. These results indicate that Aloe vera whole-leaf extract is an intestinal irritant in F344/N rats and B6C3F1 mice and a carcinogen of the large intestine in F344/N rats.
库拉索芦荟（Aloe vera）是一种草药，据称可用于治疗多种疾病；然而，关于这种膳食补充剂的安全性，仅有有限的数据。F344/N 大鼠和 B6C3F1 小鼠经口给予库拉索芦荟全叶提取物（1%、2%和 3%）13 周，结果两种动物的大肠杯状细胞增生。基于这一观察结果，进行了为期 2 年的饮水研究，以评估库拉索芦荟全叶提取物对 F344/N 大鼠（雌雄各 48 只/组，分别给予 0.5%、1%和 1.5%）和 B6C3F1 小鼠（雌雄各 48 只/组，分别给予 1%、2%和 3%）的致癌潜力。与对照组相比，雌性大鼠 1.5%剂量组的存活率降低。两种动物的肿瘤和非肿瘤病变主要局限于大肠。雄性和雌性大鼠 1%和 1.5%剂量组的回盲肠和盲肠结肠连接部、盲肠、升结肠和横结肠的腺瘤和/或癌的发生率明显高于对照组。在雄性和雌性小鼠以及大鼠的 0 或 0.5%剂量组中，大肠均未发生肿瘤。F344/N 大鼠的大肠黏膜增生发生率增加，B6C3F1 小鼠的大肠杯状细胞增生发生率增加。这些结果表明，库拉索芦荟全叶提取物对 F344/N 大鼠和 B6C3F1 小鼠是一种肠道刺激性物质，对 F344/N 大鼠是一种大肠致癌物。
