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Carcinogenicity

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Inhalation studies in animals have shown that propylene oxide produces a spectrum of upper respiratory tract changes, from inflammation and degeneration to metaplasia and neoplasia. Repeated oral administration by gavage in rats induced carcinoma in the epithelium of the forestomach.
It is evident that carcinogenic responses to propylene oxide are primarily confined to the sites of initial contact. Due to its direct-acting nature and its mutagenic activity, the carcinogenic hazard of propylene oxide expressed in animals is considered relevant to humans. In view of the potential genotoxic contribution to the carcinogenic mechanism of propylene oxide, it is not possible to establish an exposure level at which there would be no increased risk of carcinogenicity.
Classification according to Annex I of Directive 67/548/EC is proposed as follows: Carc. Cat. 2; R45 May Cause Cancer.

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