Givaudan's KeratinoSensT assay validated by EURL ECVAM

Fragrance manufacturer's biological assay for skin sensitisation testing receives approval

Givaudan's KeratinoSensT biological assay for skin sensitisation testing has been validated by The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM).

The method is based upon an engineered skin cell line that emits light if contacted by an allergen and is the culmination of years of research by Dr Andreas Natsch, Head of In Vitro Toxicology Research at Givaudan Fragrances, and his team.

EURL ECVAM confirms that the KeratinoSensT method "is transferable and reproducible within and between laboratories and can be considered as a valuable component of integrated approaches for skin sensitisation testing".

KeratinoSensT 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 sensitisation.

EURL ECVAM recommends that, before embarking on animal experiments, data from the KeratinoSensT test method should be considered in combination with complementary information in order to avoid animal testing. EURL ECVAM also indicated areas of further research to improve usage of data from KeratinoSensT. Givaudan started working on a solution to the 7th Amendment to the Cosmetics Directive - which banned the use of animal testing for cosmetic ingredients in Europe - 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 KeratinoSensT.

For a replacement test to be adopted industry-wide, it must prove to be able to be consistently applied in any laboratory. To establish that results from the KeratinoSensT test can be replicated, the method was shared with several other laboratories in the cosmetic and chemical industry as well as an independent testing lab. The different laboratories all reported highly similar test results. This study was the basis for evaluation by EURL ECVAM.

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