Chemical name: Oxirane Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All uses are prohibited Pesticide use or uses that remain allowed: None The final regulatory action was based on a risk or hazard evaluation: No Summary of the final regulatory action: The Annex I of the Ordinance on the plant protection products (OPPP) enumerates all active substances officially recognized that can be used in plant protection products. Ethylene oxide is not listed in Annex I as active substance and is thus banned in plant protection products. However, the uses of ethylene oxide as active substance in biocide products has been notified as disinfectant for public health purposes and as product for protection of foods (see Ordinance on Biocides, OBio, Annex 10, Product categories 2 and 20). This substance has a human carcinogenic potential (see 1.8.2) and is classified as a category 2 carcinogen in Switzerland. According to Annex 1.10 of the Ordinance on the Reduction of Risks linked to Chemical products (ORRChem), the substances classified as carcinogens mutagens or toxic to reproduction are forbidden to the public. This ban does not apply to medicines, paints for artists and fuels. The packaging of substances and preparations considered to be carcinogenic, mutagenic and toxic for reproduction must bear the inscription: Restricted to professional users. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: Cancer is considered the critical end-point for quantification of exposure-response for risk characterization for ethylene oxide. The lowest concentration causing a 5% increase in tumour incidence above background (TC05) from a study in rats or mice that had optimal characterization of exposure-response was 2.2 mg/me3 (unit risk = 0.05/2.2 mg/m3 = 0.023 per mg/m3) for the development of mononuclear leukaemia in female F344 rats exposed via inhalation to ethylene oxide; the lower 95% confidence limit was 1.5 mg/m3. Primarily as a basis for comparison with the tumorigenic potencies for cancer, the concentration associated with a 5% increase in the incidence of germ cell mutations (BMC05) is also presented (46 mg/m3) although it is based on dominant visible mutations only and does not take into account other genetic end-points in live offspring. Similarly, tolerable concentrations based on observed neurological or reproductive effects would be in the range of tens of micrograms per cubic metre. On the basis, predicted cancer risks in the vicinity of industrial point sources, based on limited modelling and monitoring data, are greater than 10-5. Since ethylene oxide is expected to be present primarily in air, the potential for adverse effects is greatest for terrestrial organisms, for which available data are limited. The most significant end-point with the greatest potential to result in population-level effects in wildlife was the induction of adverse reproductive effects. Comparison of the worst-case average concentration in air with the estimated no-effects value indicates that it is unlikely that terrestrial organisms are exposed to harmful levels of ethylene oxide in air. Date of entry into force of the final regulatory action: 01/08/2005 |