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Alternatives to animal testing: EURL ECVAM publishes its Recommendation on the KeratinoSens™ assay for skin sensitisation testing

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Feb 19, 2014
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KeratinoSens™ may prove a useful component of integrated approaches for skin sensitisation hazard assessment, and may also be able to contribute to the assessment of sensitising potency

On 17  February 2014 the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the European Commission's Joint Research Centre published its Recommendation on the KeratinoSens assay for skin sensitisation testing.

Chemicals can cause the immunological sensitisation of skin tissue (skin sensitisation) leading, upon repeated exposure, to an allergic reaction of the skin (Allergic Contact Dermatitis, ACD). Due the biological complexity of this effect, the intrinsic hazard and risk of chemicals to sensitise skin has been assessed by animal experiments. However, there is increasing knowledge on the key biological and physiological mechanisms underlying skin sensitisation, supporting the development of mechanism-based in vitro assays. For example, the Keap1-Nrf2- antioxidant/electrophile response element (ARE)-dependent pathway is a key signalling pathway regulating the response of skin cells (keratinocytes) to chemical stressors including sensitisers. 

The KeratinoSens™  assay uses activation of this pathway as a measure for the skin sensitisation potential of chemicals. The test method has been developed by Givaudan S.A. who also organised a validation study addressing mainly the test method’s transferability and within- and between-laboratory reproducibility. Following independent evaluation by EURL ECVAM and scientific peer review by EURL ECVAM’s Scientific Advisory Committee (ESAC), EURL ECVAM has now summarised the present validation status of the KeratinoSens and makes recommendations regarding further work and the assay's potential use within integrated approaches. 

As all EURL ECVAM Recommendations, also the present one has undergone extensive commenting by EU regulators (PARERE network), by stakeholders from industry, animal welfare and academia (ESTAF), by international partners and regulators (ICATM framework) as well as the general public. As a consequence, it is expected that this Recommendation, like EURL ECVAM's recent Recommendation on the Direct Peptide Reactivity Assay (DPRA) for skin sensitisation testing, will facilitate scientific discussions at OECD in view of developing OECD Test Guidelines for skin sensitisation.

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