Updates concerning testing for corrosion/irritation of skin and eyes

The Endpoint specific guidance R.7a was updated concerning endpoints skin corrosion/irritation and serious eye damage/eye irritation. In July 2015, the OECD updated several testing guidelines and published new ones regarding these endpoints (i.e. update: in vivo: TG 404 (skin); in vitro: TG 430, 431, 435 and 439; new - in vitro: TG 491 (STE) und TG 492 (EpiOcular)). These renewed and new testing guidelines are considered within the updated guidance. In general, in vivo testing is the standard information requirement of REACH Annex VIII (Column 1) for skin corrosion/irritation and serious eye damage/eye irritation. The reader of the guidance is reminded that due to the sequential nature of the REACH standard information requirements, at quantities of ≥10 tpa, the information requirements of Annex VII also apply. This means that in vivo testing has to be the last resort in case no adequate information can be gathered or obtained via in vitro tests. Currently, in vitro tests are able to assess skin corrosion and irritation as well as no classification can be justified, when combining several tests. There are adequate in vitro tests to determine serious eye damages and substantiate no classification. However, no validated prediction model exists to classify a chemical into eye irritation category 2 according to Regulation (EC) No. 1272/2008 (CLP). In case you have any questions regarding a current state of the art testing strategy for your chemicals, please contact our expert Ulrike Schuhmacher-Wolz.

Watch out for more news on testing skin sensitisation soon!