Margin of Exposure for Ethyl Carbamate in High Wine Consumption Group in Republic of Korea

Abstract

S-31A7-3 Background/Aims: Ethyl carbamate occurs naturally in fermented foods and alcoholic beverages such as bread, soy sauce, yogurt, wine, beer, and spirits. A number of precursors present in foods and beverages such as hydrocyanic acid, urea, and ethanol can lead to the formation of ethyl carbamate during food processing and storage. Ethyl carbamate is a multisite carcinogen and genotoxic in animals and probably carcinogenic in human. Methods: The exposure level to ethyl carbamate was calculated on the basis of mean ethyl carbamate level (0–15 μg/L) in wine and 95th percentile consumption level (432 g/d) in adult group. A risk characterization was performed using the Margin of Exposure (MOE) approach which compared a BMDL 10 derived from animal cancer study with exposure level to ethyl carbamate. A MOE value of 10,000 and above was considered to be of low concern for public health. Results: The estimated exposure level to ethyl carbamate was about 70–104 ng/kg bw/d for a 60 kg person and the exposure level including exposure from other foods was about 87–120 ng/kg bw/d. The MOEs were calculated on the basis of the estimated intake of ethyl carbamate and the BMDL 10 value of 0.3 mg/kg bw/d, and this BMDL 10 value is a corresponding dose to 10% incidence of alveolar and bronchiolar neoplasm in both male and female mice. Conclusion: The MOEs for high wine consumption group including exposure from other foods were 2493–3440. If the exposure from a variety of alcoholic beverages was considered, the MOEs could be even lower. This indicated that ALARA (As Low As Reasonably Achievable) principle should be considered to reduce and prevent the formation of ethyl carbamate in wine.