Health Assessment Document for Ethylene Oxide (External Review Draft)

Abstract

The largest single use of ethylene oxide is an intermediate in the synthesis of ethylene glycol. However, small amounts of this epoxide are used as a sterilant or pesticide in commodities, pharmaceuticals, medical devices, tobacco, and other items, representing a considerable potential for human exposure. The pharmacokinetics of ethylene oxide have not been studied extensively. While no studies found in the literature searched concerned the absorption of this chemical, toxicity data suggest that absorption occurs via the respiratory and gastrointestinal tracts. Acute exposure to ethylene oxide in humans results in symptoms of headache, vomiting, dyspnea, and diarrhea. Subacute and chronic effects are not well documented. Data indicate that many different types of genetic damage may be induced following exposure to ethylene oxide. It was found to be mutagenic in the Ames Salmonella assay to Bacillus subtilis and to Drosophilia melanogaster, as well as in cultured mammalian cell and assay systems. The alkylating and mutagenic properties of ethylene oxide are sufficient causes of concern about its potential carcinogenicity. Though there are no definitive, epidemiologic studies, the data are consistent with the animal data in that there seems to be a strong association between an increased risk of cancer, especially leukemia, and prolonged inhalation exposure to ethylene oxide.

Citation

Gray, A., B. Harris, S. Bosch, J. Santodonato, AND S. Bayard. Health Assessment Document for Ethylene Oxide (External Review Draft). U.S. Environmental Protection Agency, Washington, D.C., EPA/600/8-84/009A (NTIS PB84209873), 1984.

• HEALTH ASSESSMENT DOCUMENT FOR ETHYLENE OXIDE. EXTERNAL REVIEW DRAFT