Ethylene oxide: An overview of toxicologic and epidemiologic research

Abstract

Ethylene oxide (EtO) is a reactive epoxide and potent biocide. It is used widely in gas sterilization of hospital equipment. An estimated 75,000 health care workers in the United States have potential exposure. EtO binds covalently to deoxyribonucleic acid (DNA) and has been shown in 13 species to cause point mutations. Apparently, as a consequence of its alkylating ability, EtO exposure can result in chromosomal damage. In monkeys EtO exposure produces increased frequencies of sister chromatid exchanges (SCEs) and chromosomal aberrations. In man, five cytogenetic studies have shown dose-related increased frequencies of either SCE or chromosomal aberrations; in one study SCEs developed after regular exposures lasting less than five minutes per day. EtO is a reproductive toxin. In adult male rats, exposure produces decreased fertility, increased fetal deaths, and heritable chromosomal translocations. In pregnant female rats and rabbits, exposure causes increased fetal losses, and in one study in pregnant mice exposure was associated with increased numbers of malformed fetuses. In male monkeys EtO causes dose-related reductions in sperm count and sperm motility. In pregnant women, one study suggests that brief occupational exposure twice daily in concentrations of 20 ppm or above was associated with increased spontaneous abortions. EtO is carcinogenic to animals. In rats it causes dose-related increases in mononuclear cell leukemias, peritoneal mesotheliomas, and cerebral gliomas. In man, exposure has been associated in two epidemiologic studies with increased leukemias: 3 leukemias observed versus 0.2 expected in one study, and 2 observed versus 0.14 expected in the other; two additional small studies of limited power found no excess leukemias. Quantitative risk assessment indicates that from 634 to 1,093 excess deaths from cancer will occur per 10,000 workers exposed to EtO at 50 ppm over a working lifetime, and that 12 to 23 excess cancer deaths will occur per 10,000 workers exposed at 1 ppm. The National Institute for Occupational Safety and Health (NIOSH) recommends that EtO be regarded as a potential human carcinogen. NIOSH has recommended that eight-hour time-weighted average exposure to EtO be less than 0.1 ppm and that short-term peak exposure not exceed 5 ppm for more than ten minutes per working day.

A Study of Sister Chromatid Exchange and Somatic Cell Mutation in Hospital Workers Exposed to Ethylene Oxide

“…Malfunction of equipment or improper procedures have resulted in high levels of exposure. EO is a suspected human carcinogen. EO is carcinogenic in animals; in rats it causes dose-related increases in mononuclear cell leukemias, peritoneal mesotheliomas, and cerebral gliomas (1). Epidemiologic evidence supports the possibility that EO causes cancer in man, increasing the risk of leukemia and stomach cancer (2).…”

Aspectos toxicológicos de la exposición al óxido de etileno

“…Si bien a nivel experimental diversas publicaciones atribuyen algunos tipos de neoplasia al óxido de etileno 26,28 , los estudios epidemiológicos observacionales realizados en poblaciones humanas proporcionan resultados muy contradictorios. Así Hogsted y col.…”

Health hazard evaluation report: HETA-87-365-1848, Memorial Hospital of Southern Oklahoma, Ardmore, Oklahoma.

“…6,7 EtO is a reproductive toxin in animals, and one study suggests such an effect in humans, two epidemiological studies have associated an increase of hematologic, alimentary, and urogenital malignancies with EtO exposure. 6,9,10 EtO has also been shown to cause polyneuropathies and cataracts. 11,12,13 …”