A Nationwide Survey and Risk Assessment of Ethyl Carbamate Exposure Due to Daily Intake of Alcoholic Beverages in the Chinese General Population

Abstract

Ethyl carbamate (EC) is carcinogenic, and, in China, oral intake of EC mainly occurs as a result of the consumption of alcoholic beverages. To obtain the latest EC intake and risk analysis results for the general population in China, the China National Center for Food Safety Risk Assessment (CFSA) conducted the sixth total diet study (TDS) as a platform to analyze EC contents and exposure due to the intake of alcoholic beverages. A total of 100 sites in 24 provinces were involved in the collection and preparation of alcohol mixture samples for the sixth TDS. There were 261 different types of alcohol collected across the country, based on local dietary menus and consumption survey results. Ultimately, each province prepared a mixed sample by mixing their respective samples according to the percentage of local consumption. The EC levels of these twenty-four mixed samples were determined using our well-validated gas chromatography-mass spectrometry (GC-MS) method. The values ranged from 1.0 μg/kg to 33.8 μg/kg, with 10.1 μg/kg being the mean. China’s EC daily intake ranged from 0.001 ng/kg bw/d to 24.56 ng/kg bw/d, with a mean of 3.23 ng/kg bw/d. According to the margin of exposure (MOE), virtually safe dose (VSD), and T25 risk assessments of the carcinogenicity of EC, the mean lifetime cancer risk for the Chinese population was 9.8 × 104, 1.5 × 10−7, and 8.6 × 10−8, respectively. These data show that the carcinogenicity of EC in the general Chinese population due to alcoholic intake is essentially minimal.

Formation and hazard of ethyl carbamate and construction of genetically engineered Saccharomyces cerevisiae strains in Huangjiu (Chinese grain wine)

“…Then, using the accessible exposure data, the human dosage was determined. The LCR associated with humans was estimated by dividing the systemic exposure dose by a coefficient (HT25/0.25) (Equation 7) (Danzeisen & Verougstraete, 2018;Jung et al, 2021;Wang, Qu, et al, 2023). Calculate as follows:…”

“…VSD, a linear extrapolation, is built around gender and organ-specific tumor statistics. A determined VSD is between 20 and 80 ng/kg bw per day (Jung et al, 2021;Wang, Qu, et al, 2023). The excess CR was computed using a lifetime risk level of 10 −6 and a VSD of 20 ng/kg bw per day, as follows (Equation 8) (Jung et al, 2021):…”

“…The Joint FAO/WHO Expert Committee on Food Additives (JECFA) estimated that 0.3 mg/kg bw per day is the BMDL 10 of EC for lung cancers as the key end point in mice (Jung et al., 2021). The genotoxicity and carcinogenic risk of EC are assessed based on MOE values; safety problems from the public health perspective are categorized as possible concerns for MOE values below 10 4 , low concerns for MOE values between 10 4 and 10 5 , and negligible for MOE values beyond 10 5 (Jung et al., 2021; Wang, Qu, et al., 2023). The average intake of EC from foodstuffs other than alcoholic drinks to be approximately 15 ng/kg bw per day.…”

“…Additionally, from an acute toxicity perspective, the T25 and virtually safe dose (VSD) of lifetime cancer risk (LCR) were utilized to assess the long‐term carcinogenic risk of EC ingestion in the Chinese general population. If the CR is higher than the estimated risk level, it indicates a relatively high health risk for heavy drinkers exposed to EC (Wang, Qu, et al., 2023). The T25 method, a single‐dose reaction point extrapolation, is used in the EU to determine the precise content limitations for carcinogens (Wang, Qu, et al., 2023).…”

“…Trace amounts of ethyl carbamate (EC, commonly known as urethane) are produced in the fermentation or storage process by the interaction of ethanol with carbonyl compounds (including urea, citrulline, and carbamoyl phosphate) (Gowd et al., 2018; He & Bayen, 2020; Liu et al., 2020; Sulukan et al., 2021; Wu et al., 2016). A large number of experiments proved that EC has genetic toxicity and carcinogenic effects on animal models (Wang, Qu, et al., 2023). The National Toxicology Program (NTP), which is conducted by the U.S. Department of Health and Human Services, also concluded through a 2‐year study of rodents that ingestion of EC in rodents can lead to lung, skin, liver, breast, and stomach cancers (Abt et al., 2021; Guo et al., 2016).…”