In vitro human skin irritation test for evaluation of medical device extracts |
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Authors: | J.W. Casas G.M. Lewerenz E.A. Rankin J.A. Willoughby L.C. Blakeman J.M. McKim K.P. Coleman |
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Affiliation: | 1. Medtronic, Inc., 11520 Yellow Pine St. N. W., C202, Minneapolis, MN 55448, USA;2. CeeTox, Inc., 4717 Campus Drive, Kalamazoo, MI 49008, USA |
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Abstract: | The aim of this study was to determine if the EpiDerm? reconstructed human skin model (MatTek Corp.) could be an acceptable alternative to the ISO 10993-required rabbit skin irritation test for assessing medical device biocompatibility. Eleven medical device polymers were tested. Four extracts were prepared per polymer, two each with saline and sesame oil; half were spiked with two R-38 irritants, lactic acid for saline extracts and heptanoic acid for the sesame oil extracts. Tissue viability was assessed by MTT reduction and the proinflammatory response was assessed by IL-1α release. LOAELs of 2% for lactic acid in saline and 0.7% for heptanoic acid in sesame oil were determined. A cell viability reduction of >50% was indicative of skin irritation. Cells exposed to saline extracts spiked with 3.25% lactic acid had significantly reduced mean cell viabilities (12.6–17.2%). Cells exposed to sesame oil extracts spiked with 1.25% heptanoic acid also exhibited reduced mean cell viabilities (25.5%–41.7%). All spiked cells released substantial amounts of IL-1α (253.5–387.4 pg/ml) signifying a proinflammatory response. These results indicate that the EpiDerm? model may be a suitable in vitro replacement for the assessment of the irritation potential of medical device extracts. |
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Keywords: | Skin irritation Medical device RhE |
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