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Toxicological profiles - Ethylene oxide

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HEALTH EFFECTS 6 months, and testicular degeneration in rats exposed to 204 ppm for about 6 months (Hollingsworth et al. 1956). In Cynomolgus monkeys exposed to ethylene oxide at 50 or 100 ppm for two years, sperm concentration, motility and drive range, as well as decreased testicular and epididymal weights, were observed (Lynch et al. 1984a). Appelgren et al. (1977) demonstrated that in mice intravenously injected with 14 C-ethylene oxide, the 14C-label was detected in the testes and epididymis (at undetermined levels) within four hours.

The PB-PK model is intended to permit extrapolation to predict tissue exposures from various ethylene oxide exposure scenarios and in a variety of animal species, including humans. Eventually, a comprehensive risk assessment will combine the PB-PK model for chemical disposition and tissue dosimetry of DNA adducts with biologically-based descriptions of the cancer process. The completed PB-PK model will be used to interpret the rodent bioassay study results, to support a human risk assessment for exposure, and to interpret exposure assessment studies based on the concentration of hemoglobin adducts in exposed persons.

The highest NOAEL values and all reliable LOAEL values for reproductive toxicity in each species and duration category are presented in Table 2-1 and plotted in Figure 2-1. 7 Genotoxic Effects In studies of workers exposed to ethylene oxide, analysis of peripheral blood lymphocytes resulted in the detection of various chromosomal aberrations including breaks, gaps, and exchanges and supernumerary chromosomes (Pero et al. 1981; Galloway et al. 1986; Sarto et al. 1984a; Theiss et al. 1981). An increased incidence of sister chromatid exchange (SCE) in the peripheral lymphocytes of ethylene oxide workers has also been reported by Galloway et al.

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