Portes, P., Grandidier, M. H., Roguet, R., Cohen, C., and M. Cottin. The Use of Episkin^® for the Assessment of Cutaneous Corrosion and Irritation of Chemicals and Cutaneous Tolerance of Cosmetics. ATLA. 1999. 27: 354.

Human skin models appear to be the most promising in vitro techniques for assessing skin corrosivity and irritation. Among these models, the reconstructed human epidermis Episkin^®, has recently been scientifically validated by ECVAM as an alternative test method for skin corrosivity. The international validation study conducted by ECVAM showed that Episkin enabled corrosive chemicals to be distinguished from non-corrosive chemicals and that it was the only test method in that study able to distinguish known chemicals labelled R35 and R34. The relevance of Episkin to assess the cutaneous irritant potential of chemicals will be evaluated by a forthcoming ECVAM prevalidation study on skin irritation. In a previous study involving 17 test chemicals with historical skin irritation data (Draize skin test), our laboratory obtained a good concordance (>80%) between the in vivo data and the results of the Episkin test (MTT conversion). Episkin has also been shown to be a reliable and relevant model for the assessment of the irritant potential of finished cosmetic products. A multicentre study supported by the French Ministry of Industry and Telecommunications was carried out on 38 products, and the results were compared to irritation data obtained in humans by single patch tests. Sensitivity, specificity and concordance of the Episkin test versus in vivo data were 68%, 79% and 74%, respectively. In addition to these studies l'Oreal has been using the Episkin model for almost 10 years, and has generated results on more than 1000 proprietary products. From this background, and considering related human clinical data, the usefulness of Episkin for the assessment of cutaneous tolerance of cosmetics is clearly demonstrated.