Last reviewed 28 October 2021

The European Chemicals Agency (ECHA) has published advice to companies wanting to register chemicals under the REACH regime on how to reliably combine different sources of alternative data when assessing skin sensitisation.

Based on a recent Organisation for Economic Cooperation and Development (OECD) guideline, this reduces the need to test on animals, while protecting people from allergies.

This is the first guideline outlining how to use in silico tools (using computer simulation) such as the QSAR Toolbox to assess skin sensitisation.

ECHA’s Director for Hazard Assessment, Mike Rasenberg, said: “This is an important milestone for advancing the use of alternative methods to assess chemical hazards. With the new guideline, we make sure that this approach can be used to protect people against skin sensitisation, without the need to conduct tests on animals”.

The guideline contains defined approaches for assessing whether a substance is a skin sensitiser, and categorising whether the sensitisation is strong or moderate. This categorisation is especially important, as REACH requires skin sensitisation potency to be assessed.

If the defined approach results in a conclusion on skin sensitisation and potency, it can replace the currently used in vivo method Local Lymph Node Assay.

ECHA suggests that using the guideline will help registrants who have already submitted in chemico or in vitro data in their registrations but are uncertain whether this data is accepted by regulators.

In ECHA’s Classification and Labelling Inventory, there are over 14,000 substances on the EU market with some indication of a skin sensitising concern.

Allergic contact dermatitis is a common occupational and environmental health issue. Many skin sensitising chemicals are already restricted under REACH.

See the ECHA website for more information.