Review of noncancer risk assessment: Applications of benchmark dose methods

Abstract The overall goal of this project is to evaluate and compare risk assessment methods traditionally used for noncancer health risks and to compare them with new approaches. These methods include the no observed adverse effect level (NOAEL), lowest observed adverse effect level (LOAEL), and the more recently proposed benchmark dose (BMD), in which a dose is identified using a curve‐fitting procedure and a prespecified effect level. Applications of the BMD method are reviewed for developmental toxicity, reproductive toxicity, neurotoxicity, ecological toxicity, carcinogenicity, and other biological impacts. Evaluations have shown that the benchmark method is generally no more conservative than the NOAEL approach and confers several significant advantages for safety assessment. In addition, traditional safety factor approaches used for RfD calculation based on LOAEL values are overly conservative. Studies show that exposures at NOAELs are not “risk free”; but may represent effect levels ranging from 3...

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