Application of the margin of exposure (MoE) approach to substances in food that are genotoxic and carcinogenic: example: aflatoxin B1 (AFB1).

Aflatoxin B1 (AFB1) has been consistently shown to be a potent mutagen and is a liver carcinogen in humans and a wide range of animal species. The Fisher rat appears to be the most sensitive animal model. Dose-response modelling results in a BMDL(10) of 250 ng/kg-bw/d. Estimates of mean dietary exposure estimates were 0.4 ng/kg-bw/d and 2.6 ng/kg-bw/d, representing regions with low and high exposure, respectively. The MOEs for mean exposure therefore range from 100 to 600.