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The EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has published a recommendation on Givaudan's KeratinoSens assay, which is the first biological assay for skin sensitization testing validated by EURL ECVAM.
In a statement published in February, EURL ECVAM confirmed that Givaudan’s KeratinoSens method is transferable and reproducible within and between laboratories. The recommendation attests that KeratinoSens, developed by Dr. Andreas Natsch, head of in vitro toxicology research, and his team, can be considered as a valuable component of integrated approaches for skin sensitization testing.
KeratinoSens is based upon a genetically engineered cell line which contains a firefly gene regulated in such a way that light is emitted if the cells are contacted by an allergen. The intensity of the light signal provides a means of measurement of the risk of skin sensitization. Givaudan started working on a solution in 2006, publishing a scientific paper on the subject in 2008 that described a key stress pathway that is induced in the skin by allergens. Activation of this pathway is measured in KeratinoSens.
For a replacement test to be adopted industry-wide, it must prove to be able to be consistently applied in any laboratory. This study was the basis for evaluation by EURL ECVAM. To further establish the assay as an international standard, a draft guideline has recently been proposed to the OECD by the Swiss Federal Office of Public Health in collaboration with EURL ECVAM.