Integrated Laboratory Systems, LLC., Research Triangle Park, NC, USA.
Integrated Laboratory Systems, LLC., Research Triangle Park, NC, USA.
Food Chem Toxicol. 2021 May;151:112103. doi: 10.1016/j.fct.2021.112103. Epub 2021 Mar 23.
alpha-Glycosyl Isoquercitrin (AGIQ), is used in Japan as a food additive and was granted generally recognized as safe (GRAS) status in 2005 (FEMA) and 2007 (FDA). The safety and toxicity information for AGIQ is sparse and therefore, the carcinogenicity potential of AGIQ was examined in the CByB6F1-Tg(HRAS)2Jic (rasH2) model. One hundred female and male rasH2 mice, each, were allocated to one of four designated dose groups; 0 (control)%, 1.5%, 3.0% or 5.0% AGIQ. Animals were administered the diets for six months and an additional 10 females and 10 males, each, were administered a positive control, N-methyl-N-nitrosourea (MNU). Body weights and clinical observations were collected. A full screen necropsy, organ weights, clinical chemistry, urinalysis and histopathology were performed. The positive control animals elicited appropriate responses specific to this strain (rasH2) of mice. There were statistically significant sporadic non-dose-dependent changes in clinical chemistries without corresponding pathological correlation. No microscopic AGIQ-related findings were noted; the range of pathology observations were all considered background findings, either specific to rasH2 mice or common to inbred strains of mice. Therefore, under the study conditions, the no-observed-adverse-effect level (NOAEL) was determined to be more than 5.0% (7215.4 mg/kg BW/day in male mice and 14685.5 mg/kg/day in female mice).
α-糖苷基异槲皮苷（AGIQ）在日本被用作食品添加剂，并于 2005 年（FEMA）和 2007 年（FDA）获得了公认安全（GRAS）地位。AGIQ 的安全性和毒性信息很少，因此，在 CByB6F1-Tg(HRAS)2Jic（rasH2）模型中检查了 AGIQ 的致癌潜力。将 100 只雄性和雌性 rasH2 小鼠，分别分配到四个指定剂量组之一；0（对照）%、1.5%、3.0%或 5.0%AGIQ。动物接受饮食 6 个月，另外 10 只雌性和 10 只雄性接受阳性对照 N-甲基-N-亚硝脲（MNU）。收集体重和临床观察数据。进行全面尸检、器官重量、临床化学、尿液分析和组织病理学检查。阳性对照动物引起了与该品系（rasH2）小鼠特异性的适当反应。临床化学中有统计学意义的零星非剂量依赖性变化，但没有相应的病理相关性。未观察到与 AGIQ 相关的微观发现；病理观察范围均被认为是背景发现，要么是 rasH2 小鼠特有的，要么是近交系小鼠共有的。因此，在研究条件下，未观察到不良效应水平（NOAEL）确定为超过 5.0%（雄性小鼠为 7215.4mg/kgBW/天，雌性小鼠为 14685.5mg/kg/天）。
