Adoption of the Human Cell Line Activation Test (h-CLAT; OECD TG 442E) represents a critical step towards the full replacement of animals used in experiments to assess skin sensitisation. The h-CLAT method addresses the third key event of the skin sensitisation adverse outcome pathway and can be used in combination with the in chemico Direct Peptide Reactivity Assay (DPRA; OECD TG 422C) and the in vitro ARE-Nrf2 Luciferase Test Method (OECD TG 442D) to predict skin sensitisation.
As the REACH requirements for skin sensitisation in Annex VII have been updated making non-animal testing the default requirement, registrants must use the in vitro methods wherever possible. The updated Annex is expected to come into force in the autumn of 2016 and a draft is available here.
For more information on skin sensitisation testing, see our factsheet here.