The KeratinoSens in vitro test method for skin sensitisation testing, developed by Givaudan, has been evaluated by ECVAM. The full recommendation and summary data pdfs can be found by following the link above. In summary, ECVAM found that the Keap1-Nrf2-ARE pathway is relevant for assessing skin sensitization. They recommend that the KeratinoSens assay be used in combination with other assays (such as the Direct Peptide Reactivity Assay) in a Weight of Evidence (WOE) approach or as part of an Integrated Testing Strategy (ITS) for skin sensitization. The assay has good predictive capacity and was shown to be transferable between laboratories. Additional work is recommended by ECVAM to evaluate the assay's ability to relate potency catagories to human data. ECVAM states that "Respecting the provisions of Directive 2010/63/EU (EU, 2010) on the protection of animals used for scientific purposes, before embarking on animal experiments to identify substances with skin sensitisation potential, data from the KeratinoSens test method should be considered in combination with complementary information in order to reduce and possibly avoid animal testing. As provided for in Annex XI (point 1.2) of the REACH Regulation (EC, 2006), data from non-standard testing methods, such as the KeratinoSens, may be used to adapt the standard information requirement in the context of Weight-of-Evidence (WoE) judgments."