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Reevaluation of ethylene oxide hemolysis and irritation potential
Author(s) -
Anand V. P.,
Cogdill C. P.,
Klausner K. A.,
Lister L.,
Barbolt T.,
Page B. F. J.,
Urbanski P.,
Woss Casimir J.,
Boyce John
Publication year - 2003
Publication title -
journal of biomedical materials research part a
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.849
H-Index - 150
eISSN - 1552-4965
pISSN - 1549-3296
DOI - 10.1002/jbm.a.10422
Subject(s) - hemolysis , irritation , ethylene oxide , cheek pouch , biocompatibility , in vivo , materials science , aqueous solution , chromatography , chemistry , hamster , medicine , organic chemistry , immunology , biology , composite material , microbiology and biotechnology , copolymer , metallurgy , polymer
The in vitro hemolytic and in vivo mucosal irritation potential of ethylene oxide (EO) was investigated with standard procedures used to determine the biocompatibility of medical devices. Test solutions containing EO at concentrations of 25, 50, 100, 250, 500, 1,250, 2,500, 5,000, or 10,000 μg/mL were prepared in saline to simulate a worst‐case aqueous extraction of standard medical devices containing 125, 250, 500, 1,250, 2,500, 6,250, 12,500, 25,000, or 50,000 μg/g of EO, respectively. Concentrations of EO up to 500 μg/mL were not hemolytic (<5% hemolysis after a 4‐h exposure), whereas ≥1250 μg/mL of EO resulted in significant hemolysis. Hamster cheek pouches exposed to cotton pellets saturated with EO at concentrations of up to 2500 μg/mL for 4 h with a recovery period of 14 days were without effects attributable to EO. However, at ≥5000 μg/mL of EO, significant histomorphological alterations of the buccal mucosa were observed and attributed to EO exposure. It was concluded that solutions of EO of up to 500 μg/mL representing an aqueous extract of a general medical device containing at least 2500 μg/g of EO residue do not result in significant hemolysis and irritation. © 2003 Wiley Periodicals, Inc. J Biomed Mater Res 64A: 648–654, 2003