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Food Chem Toxicol. 2012 Aug;50(8):2845-53. doi: 10.1016/j.fct.2012.05.013. Epub 2012 May 18.
The safety of the apple polyphenol extract EvesseEPC, which is rich in flavan-3-ols, particularly epicatechin, was evaluated. Both in a bacterial reverse mutation test and a mouse lymphoma assay, EvesseEPC showed a positive response in vitro. In vivo studies (UDS test in hepatocytes, bone marrow micronucleus test and comet assay in intestinal cells) were all negative and hence Evesse EPC is considered not to have genotoxic properties in vivo. In a 90-day study in rats, EvesseEPC was administered at dietary levels of 0%, 1.25%, 2% and 3.25%. Body weights were decreased in the high-dose group in both sexes without effects on feed or water intake. In the high-dose group, thrombocytes (males) and creatinine (both sexes) were decreased, prothrombin time (males) was increased, and liver, kidneys and spleen weights were increased (males), without histological correlates. Diffuse acinar cell hypertrophy, observed in the parotid salivary glands in all treatment groups, was not considered as adverse and presumably reflected a local, reversible and adaptive response to direct contact with EvesseEPC. The NOAEL for EvesseEPC in rats was 2% in the diet, equivalent to an overall average intake of 1.3 and 1.5 g/kg body weight/day for males and females, respectively.
安全性的评估苹果多酚提取物 EvesseEPC，富含黄烷-3-醇，特别是表儿茶素。在细菌回复突变试验和小鼠淋巴瘤试验中，EvesseEPC 均表现出体外阳性反应。体内研究（肝细胞 UDS 试验、骨髓微核试验和肠细胞彗星试验）均为阴性，因此 EvesseEPC 被认为在体内没有遗传毒性。在大鼠 90 天研究中，EvesseEPC 以 0%、1.25%、2%和 3.25%的饮食水平给药。在雄性和雌性中，高剂量组的体重均降低，但饲料和水的摄入量不受影响。在高剂量组中，血小板（雄性）和肌酐（雌雄）降低，凝血酶原时间（雄性）升高，肝脏、肾脏和脾脏重量增加（雄性），但无组织学相关性。在所有治疗组中观察到的唾液腺腺泡细胞弥漫性肥大，被认为不是不利的，可能反映了与 EvesseEPC 的直接接触引起的局部、可逆和适应性反应。大鼠中 EvesseEPC 的无可见不良作用水平为 2%饮食，相当于雄性和雌性的平均日摄入量分别为 1.3 和 1.5 g/kg 体重。
