Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts
Review articleOpen access
Abstract:

Highlights•Alternative in vitro testing of medical device extracts for irritation is possible.•Reconstructed human epidermis (RhE) model detects presence of irritant in extracts.•High predictivity RhE model for presence of strong irritants in material extracts.•Predictivity in saline or sesame oil extract depends on hydrophilicity of irritant.•Four positive polymer test materials containing a known irritant were evaluated.

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