主题:【原创】对所谓FDA三聚氰胺安全标准的分析 -- 小玩意
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The point of departure (POD) is the NOAEL of 63 mg/kg/day from the rodent subchronic bioassay. This POD was then divided by two 10-fold safety/uncertainty factors (SF/UF) to account for inter- and intra-species sensitivity, for a total SF/UF of 100. The resulting Tolerable Daily Intake (TDI) is 0.63 mg/kg bw/day. The TDI is defined as the estimated maximum amount of an agent to which individuals in a population may be exposed daily over their lifetimes without an appreciable health risk with respect to the endpoint from which the NOAEL is calculated.
NOAEL=不会引起任何可观察负面作用的剂量
在大鼠身上每天63mg/kg以下的摄入量不会引起任何可观察的负面作用。FDA也知道这个数值直接套用在人身上并不保险,因此加入物种/个体差异安全因子(稀释10倍),未知因素安全因子(稀释10倍),推测出人的每日可容忍摄入量:
63mg/kg/day*0.1*0.1=0.63mg/kg/day
很多安全标准就是靠动物实验加上“以防万一”的安全因子推测出来的,毕竟FDA不可能拿活人来搞安全剂量试验。
- 相关回复 上下关系8
🙂你烦还是我烦? 小玩意 字442 2008-09-18 12:17:10
🙂你晕吧,我帮你打911 二胡 字235 2008-09-18 12:28:52
🙂不是我狡辩 1 小玩意 字301 2008-09-18 12:40:12
🙂请看原文,大鼠做出来的NOAEL是63mg/kg/day
🙂仍然不影响我的结论 2 小玩意 字485 2008-09-18 06:02:23
🙂你在用更离谱的错误来解释原本的主张,何必呢? 7 卷心菜 字763 2008-09-18 06:58:53
🙂食品和保健品上市不需要FDA报批? 2 小玩意 字508 2008-09-18 07:16:48
🙂看看你之前说的是什么... 1 卷心菜 字1022 2008-09-18 08:26:57