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 BMDL(10) of 0.25 mg/kg-bw/day. The dietary exposure from consumption of foods and non-alcoholic beverage was estimated to be 1 microg/person/day (15 ng/kg-bw/day), while the exposure of a high-percentile consumer of alcoholic beverages was estimated to be 5 microg/person per day (80 ng/kg-bw/day). The corresponding calculated MOEs were 16600 and 3125, respectively. Copyright 2009 ILSI Europe. Published by Elsevier Ltd.. All rights reserved.