Monro A, Davies T S
Pfizer Central Research, Groton, CT 06340.
Cancer Lett. 1993 Dec 20;75(3):183-94. doi: 10.1016/0304-3835(93)90061-d.
Guidelines for the conduct of rodent carcinogenicity studies stipulate that when the test substance is administered via the diet, its concentration need not exceed 5% of the diet. Since it is now apparent that human carcinogens are amongst the most potent of rodent carcinogens, it should be possible to detect accurately potential human carcinogens by using only relatively low dose levels in rodent studies. Our analysis of the potency of human carcinogens in rodent studies leads to the conclusion that, even after applying a safety factor of 10, there is no purpose in using dose levels higher than 500 mg/kg body weight or 1% in the diet.
啮齿类动物致癌性研究的实施指南规定,当通过饮食给予受试物质时,其浓度不应超过饮食的5%。由于现在很明显人类致癌物属于啮齿类动物致癌物中最具致癌性的物质,因此在啮齿类动物研究中仅使用相对较低的剂量水平就应该能够准确检测出潜在的人类致癌物。我们对啮齿类动物研究中人类致癌物致癌性的分析得出结论,即使应用了10的安全系数,使用高于500毫克/千克体重或饮食中1%的剂量水平也没有意义。