# 关于NDMA限值计算

NDMA基本信息：

CAS号：62-75-9

------------------------引用开始

Note 4Example of linear extrapolation from the TD50

It is possible to calculate a compound-specific acceptable intake based on rodent carcinogenicity potency data such as TD50values (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 life time 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/kgbody 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 = 0.42μg/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 dailylife-long intake of 21.3 μg ethylene oxide would correspond to a theoretical cancer risk of 10-5 and therefore be an acceptable intake when present as an impurity in a drug substance.

------------------引用完

https://toxnet.nlm.nih.gov/cpdb/chempages/N-NITROSODIMETHYLAMINE.html

0.0959 μg÷320mg = 0.0003μg/mg =0.3ppm

0.189mg/kg÷50,000×50kg÷320mg=0.00059μg/mg=0.6ppm

----以下再讲WHO的IARC（材料和工具：网络+电脑+人脑）----

（动物致癌证据充分，人体致癌未证明）

• 发表于:
• 原文链接https://kuaibao.qq.com/s/20180727G0KPIV00?refer=cp_1026
• 腾讯「腾讯云开发者社区」是腾讯内容开放平台帐号（企鹅号）传播渠道之一，根据《腾讯内容开放平台服务协议》转载发布内容。
• 如有侵权，请联系 cloudcommunity@tencent.com 删除。

2022-08-13

2018-07-11

2022-08-13

2022-08-13

2022-08-13

2022-08-13

2022-08-13