エチレンオキサイドの溶血性および皮膚刺激性について

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To evaluate the biocompatibility of residual ethylene oxide in sterilized disposable medical devices, the hemolytic activity in vitro and the rabbit dermal irritability of ethylene oxide and its reaction products were investigated.Ethylene oxide and ethylene chlorohydrin showed a dose-dependent hemolytic activity, but ethylene chlorohydrin had less than 2% of the hemolytic activity of ethylene oxide. Ethylene glycol showed no hemolytic change even at a concentration of 20%.Several plastic and rebber tubes were sterilized with ethylene oxide and placed in contact with rabbit blod. Polyurethane, polyvinyl chloride and natural rubber tubes showed a marked hemolysis which was detectable during 3 to 7 days after sterilization, while silicone rubber tubes showed a slight hemolysis only for a few hours. The hemolytic action of the sterilized polyvinyl chloride did not necessarily depend on the amount of plasticizer added to it. Unsterilized natural rubber tubes also showed a marked hemolysis.Ethylene oxide showed a dermal irritability when applied on the skin of rabbit at concentrations of 1% and 3%. The dermal irritability of ethylene oxide was demonstrated to be comparable to that of sulfuric acid in the irritation scores. Ethylene chlorohydrin and ethylene glycol failed to cause any dermal damage even by the application of 0.5% solution.It is concluded that the hemolytic activity and the dermal irritability of ethylene oxide found in this study indicate a potential biological incompatibility of sterilized disposable medical devices if residual ethylene oxide is not adequately desorbed.
日本医療機器学会の論文
1982-01-01

エチレンオキサイドの溶血性および皮膚刺激性について

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