Botham, P. Skin Corrosion and Irritation: Toward Complete Replacement. ATLA 1999. 27: 108.

In 1998, ECVAM endorsed the successful validation of two in vitro methods for assessing skin corrosion potential: a test which employs a human skin model (EpiskinÔ); and the rat skin transcutaneous electrical resistance (TER) assay. Subsequently, a draft new OECD guideline predicting skin corrosive substances. Importantly, the section of the guideline on the human skin assay has been drafted to allow for the use of other human skin models if and when they are also validated. A retrospective analysis of the OECD’s stepwise testing strategy for skin corrosion/irritation using data from 60 chemicals revealed that substances could be classified as corrosive or non-corrosive with sufficient reliability by the sequential use of structure-activity relationships, pH measurements and one of the above-mentioned validated in vitro methods (Worth et al. ATLA 26, 709-720, 1998). As a follow-up to this success, ECVAM recognized the urgent need to make progress in validating in vitro tests for skin irritation. A Task Force was established which set a “challenge” to developers/users of relevant methods to submit data, obtained according to a specified protocol with a preliminary prediction model, on ten defined test chemicals. This resulted in an agreement that four tests – EpiskinÔ, EpidermÔ, PrediskinÔ, and the non-perfused pig ear model – should proceed to prevalidation. The prevalidation study will be completed in April 2000; a subsequent validation study, if successful, could then allow the complete OECD testing strategy for skin corrosion and irritation to be followed without the use of live animals.