环氧氯丙烷基因毒性数据？参考文件 ICH M7 It is possible to calculate a compound-specific acceptable intake based on rodent carcinogenicity potency data such as TD50 values (doses giving a 50% tumor incidence equivalent to a cancer risk probability level of 1:2). Linear extrapolation to a probability of 1 in 100,000 (i.e., the accepted lifetime risk level used) is achieved by simply dividing the TD50 by 50,000. This procedure is similar to that employed for derivation of the TTC. Calculation example: Ethylene oxide TD50 values for ethylene oxide according to the Carcinogenic Potency Database are 21.3 mg/kg body weight/day (rat) and 63.7 mg/kg body weight/day (mouse). For the calculation of an acceptable intake, the lower (i.e., more conservative) value of the rat is used. To derive a dose to cause tumors in 1 in 100,000 animals, divide by 50,000: 21.3 mg/kg ? 50,000 = 0.42 μg/kg To derive a total human daily dose: 0.42 μg/kg/day x 50 kg body weight = 21.3 μg/person/day Hence, a daily life-long intake of 21.3 μg ethylene oxide would correspond to a theoretical cancer risk of 10-5 and therefore be an acceptable intake查看更多
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