APPLICATION OF AN IN VITRO METHOD FOR SKIN CORROSION TESTING TO A VARIETY OF COMMERCIALLY AVAILABLE SKIN CULTURES.
National and international regulations require that chemicals must be properly classified, labeled, packaged, and transported based on their ability to damage or destroy tissue, e.g., skin. Traditional rabbit tests for assessing skin irritation or corrosion are based on the methods of Draize et al. (1944). Scientists at Procter & Gamble Co. previously reported an in vitro skin corrosion screen based on the use of in vitro human skin equivalent cultures. P&G developed this model as a potential replacement for the in vivo rabbit skin test method for corrosion, specified by the U.S. Dept. of Transportation (DOT). In this in vitro skin corrosion method, test materials were applied topically to a human skin equivalent culture (Advanced Tissue Sciences [ATS] Model ZK1300), and decreased cell viability (MTT assay) was measured in time course experiments. In the ZK1300 human skin in vitro model, corrosive materials were accurately distinguished from strong, moderate and mild test materials with a cutoff of ET-50< 3 minutes (i.e., scientists correctly identified DOT corrosives as those test materials reducing cell viability by 50% at less than three minute test material exposure times). More recently the ZK1300 human skin cultures have been reduced in size from an 11 mm format to a 9 mm format. In the present work P&G scientists verified that the ET-50 cutoff they established for corrosives in the ZK1300 held for the smaller (ZK1301) cultures. P&G scientists have also shown that their in vitro skin corrosive test method can be applied to other commercially available human skin equivalent cultures. P&G scientists have shown that the ET-50 cutoff for corrosives can be used to distinguish corrosives from non-corrosives in the MatTek EpiDerm model. P&G scientists concluded that the in vitro assay using human skin equivalent cultures is a promising alternative to in vivo rabbit skin corrosion tests that can be used across different sources of human skin cultures.
Chemicals, Corrosion, Corrosivity, Corrosivity testing, Cutaneous irritancy, Cutaneous irritation, Cutaneous toxicity, Dermal corrosion, Dermal irritancy, Dermal irritancy testing, Dermal irritation, Draize prediction model, Draize scores, Draize tests, Endpoints, MTT, EpiDerm, MTT, MTT ET-50 tissue viability assay, MTT assay, Pre-validation, Prediction model, Prevalidation, Skin corrosion, Skin corrosivity, Skin irritancy, Skin irritation, U.S. Department of Transportation (DOT), Validation, Viability
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