Effects On Monkeys And Rats Of Long-Term Inhalation Exposure To Ethylene Oxide: Major Findings Of The NIOSH Study.
Lynch DW; Lewis TR; Moorman WJ; Burg JR; Lal JB; Setzer JV; Groth DH; Gulati DK; Zavos PM; Sabharwal PS; Ackerman LJ; Cockrell BY; Sprinz H
Association for the Advancement of Medical Instrumentation, Technology Assessment Report No. 8-84, Inhospital Ethylene Sterilization, Current Issues in EO Toxicity and Occupational Exposure 1984:7-10
The effects of long term inhalation exposure to ethylene-oxide (75218) were studied in monkeys and rats. Male Fischer-344-rats and Cynomolgus-monkeys were exposed to 50 or 100 parts per million (ppm) ethylene-oxide 7 hours daily, 5 days per week for 24 months. The rats were used for a lifetime carcinogenesis bioassay. The monkeys were used to determine effects of ethylene-oxide on specific organs. The animals were observed for signs of toxicity. Rats were assayed for tumor incidence. Monkeys were killed at selected times and examined for changes in hematology, clinical and urine chemistry, ophthalmology, spermatozoa, neuropathy, neurophysiology, sister chromatid exchange rates, and chromosomal aberrations in peripheral lymphocytes. Exposure to 50 and 100ppm ethylene-oxide reduced weight gain in rats. Survival of rats was adversely affected; mortality was dose dependent. Exposure to ethylene-oxide caused significant increases in the incidence of mononuclear cell leukemia, peritoneal mesotheliomas, and gliomas. Monkeys exposed to ethylene- oxide tolerated the exposures well. Exposure to 100ppm significantly decreased body weight. Ethylene-oxide did not cause any significant changes in hematological, clinical or urine chemistry, or ophthalmological parameters. Exposure to 100ppm ethylene-oxide decreased nerve conduction velocities. Evidence of neurotoxicity and demyelination was found at both ethylene-oxide doses. Ethylene-oxide caused a significant reduction in sperm counts and motility. Both ethylene-oxide doses caused significant increases in the incidence of sister chromatid exchanges and chromosomal aberrations. The authors conclude that ethylene-oxide causes statistically significant toxic, mutagenic, and carcinogenic responses in rats and monkeys.
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