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.
Schlatter
Josef
J
Federal Office of Public Health, Switzerland. publications@ilsieurope.be
Dinovi
Michael
M
Setzer
R Woodrow
RW
D018686:Anesthetics, Intravenous / Q000633:toxicity*; D000818:Animals; D002273:Carcinogens / Q000633:toxicity*; D003627:Data Interpretation, Statistical; D004032:Diet; D004305:Dose-Response Relationship, Drug; D005260:Female; D005506:Food Contamination / Q000032:analysis*; D006801:Humans; D008297:Male; D051379:Mice; D015233:Models, Statistical; D009153:Mutagens / Q000633:toxicity*; D051381:Rats; D014520:Urethane / Q000633:toxicity*
D018686:Anesthetics, Intravenous; D002273:Carcinogens; D009153:Mutagens; D014520:Urethane