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Improvements in alternative methods for skin corrosion testing

April 22nd, 2016

A tiered system for skin corrosion and irritation testing, employing in vitro models, is an established part of the current OECD testing strategy used for REACH. The approach allows for the discrimination between substances which are not classified and those which require classification as corrosive (Skin Corr. Category 1) or irritant (Skin Irrit. Category 2) according to the criteria specified in Regulation (EC) No. 1272/2008 on Classification and Labelling and Packaging of substances and mixtures (CLP). For corrosivity testing applying OECD Test Guideline 431 (In vitro skin corrosion: reconstructed human epidermis (RhE) test methods, the severity of the effect can be assigned into the CLP subcategories 1A, 1B and 1C, based on the percentage of viable cells remaining at the end of the study exposure time.

At present, OECD 431 includes four different validated methods using different commercially available RhE models. However, a recent study by the European Commission’s Joint Research Centre (JRC) reviewed the accuracy of the different methods, EpiSkin SCT, EpiDerm, SkinEthic RHE and epiCS, concluding that only EpiSkin SCT is reliable. The other three methods were seen to provide inaccurate subcategorisation and require further confirmation through other methods, even though they are currently recommended by the OECD TG 431.

Alternative methods are continuing to emerge as an important future direction and replacement to animal testing, and are under ongoing review and improvement. PFA can provide expert guidance in the selection of appropriate tiered testing strategies for skin and eye irritation.