PHAR 100 Chapter Notes - Chapter 5.4.2: Food Additive, Extrapolation

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One can easily determine the efficacy of a food additive. However, it is very difficult to determine how to determine how toxic a food additive is. Risk/ benefit ratio is prob what is used to determine if an additive is okay. There many limitations to this technique: exposure, assumption of risk. It is tough to use animals to replicate how much exposure humans will receive. Additives are not administered that much to animals ~ probably for one or two years. On the other hand, humans are exposed for a lifetime ~ like 80 years. Therefore, when risk estimates are made they must be assessed on a lifetime of exposure. This is divided by 100 or 1000 to be the acceptable human exposure limit or dose: the acceptable human exposure limit or dose is taken as. 1/100 or 1/1000 of the max no-effect dose in animals .

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