General Information

Functional Class:
  • Food Contaminant


Evaluation year: 2006
Comments: The Committee concluded that ethyl carbamate is a genotoxic, multisite carcinogen in all species tested and that cancer was the critical endpoint for human health risk assessment. The pivotal study for risk assessment was a recent drinking water bioassay in mice. The increased incidences of alveolar and bronchiolar adenoma or carcinoma in mice was considered to be the critical effect in the study. Benchmark dose modeling produced BMDL10 values that ranged from 0.3 to 0.5 mg/kg bw/d. The margins of exposure between the lower bound of the BMDL10 range of 0.3 mg/kg bw/d and the mean and high intake values for ethyl carbamate in the diet were 20 000 and 3800, respectively. The Committee concluded that intake of ethyl carbamate from foods excluding alcoholic beverages would be of low concern. The margin of exposure for all intakes, food and alcoholic beverages combined, was of concern and therefore mitigation measures to reduce concentrations of ethyl carbamate in some alcoholic beverages should be continued.
Intake: Mean intake from food = 15 ng/kg bw per day; high intake from food and alcoholic drinks = 80 ng/kg bw per day
Tolerable Intake: NONE ESTABLISHED; genotoxic carcinogen
Meeting: 64
Report: TRS 930-JECFA 64/31
Tox Monograph: FAS 55-JECFA 64/205
Estimated exposure

Best estimate: 1-4 µg/day

Toxicological study
Pivotal Study: Lifetime study of carcinogenicity in B6C3F1 mice (Inai, 1991): B6C3F1 mice (n=47-48/sex/group) were given drinking-water containing ethyl carbamate at a concentration of 0, 10, 30 or 90 mg/l together with ethanol at a concentration of 0, 2.5% or 5%. Results from the animals that did not receive ethanol were used as the basis of the present evaluation. In these animals, intakes of ethyl carbamate were equal to approximately 0, 1, 3 or 9 mg/kg of body weight per day, respectively. Treatment with ethyl carbamate resulted in dose-dependent increased incidences of alveolar and bronchiolar, hepatocellular and Harderian gland adenoma or carcinoma, hepatic haemangiosarcoma, and mammary gland adenoacanthoma or adenocarcinoma (females only). Smaller, but still statistically significant, increases were observed in the incidence of haemangiosarcoma of the heart (males only) andspleen (females only), squamous cell papilloma or carcinoma of the forestomach and skin (males only) and benign or malignant ovarian granulosa cell tumours. Induction of lung tumors was considered the critical effect.
Animal specie: B6C3F1 mice
Effect: Lung tumors: Alveolar and bronchiolar neoplasms
NOAEL: Not established. Increased tumor incidences were noted at all doses tested in the study.
Point of departure: BMDL10: 0.3 mg/kg bw/day