Benchmark dose in regulatory toxicology

Abstract

The Benchmark-Dose (BMD) approach aims at determining an exposure level/dose corresponding to a predefined change in response (the Benchmark Response – BMR) – usually defined over background – and allows using all available dose–response (DR) information by fitting mathematical models to those data. The confidence interval of the BMD estimate accounts for the statistical uncertainty in the data and the lower (one-sided) confidence limit, denoted BMDL, is used as reference point (RP) or point-of-departure (PoD) for the characterization of the risk of hazardous compounds replacing the no–observed–adverse–effect level (NOAEL) when sufficient DR data are available. The concept, the requirements for application, and practical applications of the BMD approach are presented in this chapter.