Advice for registrants on skin sensitisation testing helps reduce animal tests

The European Chemicals Agency (ECHA) has published advice on using new OECD test guidelines related to skin sensitisation.The new non-animal test guidelines each address a specific key event in the adverse outcome pathway for skin sensitisation, describing the main biological steps in skin sensitisation. They are relevant for many registrants preparing for the 2018 REACH registration deadline and, if used correctly, can replace the need to use animal test methods. The adopted OECD test guidelines are:

  • 442C: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA), and
  • 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method (KeratinosensTM).


The draft OECD test guideline is:

  • In Vitro Human Cell Line Activation Test (h-CLAT).

Registrants should get familiar with the advice and consider whether they could use the new methods instead of in vivo skin sensitisation test methods. Due to the complexity of skin sensitisation, the methods should be used as a combination in an integrated approach to testing and assessment. The non-animal methods may not be suitable for all substance types and where it is justified in vivo tests may still be necessary. ECHA’s guidance R.7a is being updated and will be published in 2016. It will give more detailed advice on how these non-animal testing methods can be used for REACH. Further information is available at: Information note on new skin sensitisation methods – ECHA’s EU/OECD test methods

ECHA, 27 April 2015 ; ;