Skin irritation: waiving of in vivo study possible

Annex VIII to X of the REACH regulation require in vivo testing for skin irritation except the specific rules for adaptation mentioned in column 2 apply. But, as outlined in a recent ChemicalWatch Webinar even if column 2 does not apply in vivo testing is not automatically necessary. According to Annex XI it can be waived if adequately and reliably documented results of validated in vitro assays which are sufficient for classification are available.  For the endpoint skin irritation this refers to a validated in vitro assay on skin corrosion (e.g. OECD 430, 431 or 435) and – in case of a negative result – followed by a validated in vitro skin irritation assays (e.g. OECD 439). Please contact us for further information.