Application of the margin of exposure (MoE) approach to substances in food that are genotoxic and carcinogenic: Example: Ethyl carbamate (CAS 51-79-6)

Ethyl carbamate is mutagenic and produces DNA-adducts in vivo, and is carcinogenic in rodent bioassays. Dose-response modelling of the data for alveolar and bronchiolar adenoma or carcinoma in male and female mice combined gave a BMDL10 of 0.25 mg/kg-bw/day. The dietary exposure from consumption of foods and non-alcoholic beverage was estimated to be 1 μg/person/day (15 ng/kg-bw/day), while the exposure of a high-percentile consumer of alcoholic beverages was estimated to be 5 μg/person per day (80 ng/kg-bw/day). The corresponding calculated MOEs were 16600 and 3125, respectively.