Background: Ethylene oxide is a sterilant gas that causes leukemia and other cancers in animals. Studies in Sweden have shown an excess of leukemia and stomach cancer in humans exposed to ethylene oxide, but other studies have generally failed to confirm these findings.
Methods: We conducted a study of mortality in 18,254 U.S. workers exposed to ethylene oxide at 14 plants producing sterilized medical supplies and spices. The subjects averaged 4.9 years of exposure to the gas and 16 years of follow-up. The exposure levels in recent years averaged 4.3 ppm (eight-hour time-weighted adjusted exposure) for sterilizer operators and 2.0 ppm for other workers. The levels in earlier years are likely to have been several times higher. Mortality in this cohort was compared with that in the general U.S. population.
Results: Overall there was no significant increase in mortality from any cause in the study cohort. The standardized mortality ratios (SMRs) were 0.97 for leukemia (95 percent confidence interval, 0.52 to 1.67; 13 deaths observed), 1.06 for all hematopoietic cancers (95 percent confidence interval, 0.75 to 1.47; 36 deaths), and 0.94 for stomach cancer (95 percent confidence interval, 0.45 to 1.70; 11 deaths). Analyses according to job category and according to the duration of exposure showed no excess in cancers, as compared with the rate in the general population, but there was a significant trend toward increased mortality with increasing lengths of time since the first exposure for all hematopoietic cancers. The rate of death from hematopoietic cancer (especially non-Hodgkin's lymphoma) was significantly increased among men (SMR, 1.55; 27 deaths). Mortality from leukemia in recent years (1985 through 1987) was significantly increased among men (SMR, 3.45; 5 deaths).
Conclusions: For the entire cohort, there was no increase in mortality from hematopoietic cancer. There was a slight but significant increase among men, however. Among men and women combined, there was a trend toward an increased risk of death from hematopoietic cancer with increasing lengths of time since the first exposure to ethylene oxide.