‘Important milestone’: ECHA publishes advice on applying OECD non-animal skin sensitisation assessments under REACH

ECHA said applying this guideline would advance the use of non-animal test methods, while protecting people from allergies.

In silico​ tools for chemical skin sensitisation assessment​

Published in June 2021, the OECD 497 Guideline on Defined Approaches for Skin Sensitisation​​​ was the first guideline outlining how to use in silico​ tools, or computer simulation, to assess skin sensitisation. Centred on 10+ years of collaborative work​ between chemistry major BASF and fragrance major Givaudan, the guideline detailed a multi-pronged skin sensitisation assessment strategy that cross-read data from three separate non-animal methods.

ECHA now wanted to highlight how industry could apply this guideline under the REACH regulation and had published an advice document​ summarising the OECD non-animal skin sensitisation tests, outlining how they could be used and detailing to what extent these assessments met REACH information requirements.

“This is an important milestone for advancing the use of alternative methods to assess chemical hazards,” ​said Mike Rasenberg, director for hazard assessment at ECHA. “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.”​

Rasenberg said ECHA had “contributed significantly”​ to the guideline, working “in close cooperation”​ with the OECD, Joint Research Centre and other organisations.

‘Defined approaches’ for animal-free skin sensitisation assessment ​

ECHA also highlighted the QSAR Toolbox​ which was part of the OECD’s guideline – a free software application developed by the agency and the OECD designed to support reproducible and transparent chemical hazard assessment.

ECHA said the OECD guideline and QSAR Toolbox could be used by companies who had already submitted in chemico​ or in vitro​ data, to assess whether this data would be accepted under REACH. It would also prove valuable to registrants looking to select the most suitable tests to generate new data for substances, the agency said.

“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,”​ ECHA said.

“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, reducing testing on animals.”​

Under ECHA’s Classification and Labelling Inventory​, there were more than 14,000 substances on the EU market identified with some indication of a skin sensitising concern, many of which were already restricted under REACH.

Timely advice amidst beauty kickback around REACH animal data​

ECHA’s move to publish advice on how to apply the OECD guideline was especially timely, given the agency and its Board of Appeal had been under fire for some time because of demands for animal data that the cosmetics and personal care industry said undermined the EU animal testing ban on cosmetics​.

Whilst ECHA had long maintained animal testing should only be used as a last resort, and said it was the European Commission in charge of the EU Cosmetics Regulation​, under REACH, currently, some animal testing was still required for safety assessments around environmental endpoints, long-term worker safety and pre-registration of some new chemical substances. Industry had rallied together to call this out as wrong with joint open letters, statements and collaboration with global NGOs and associations to call for change.

In the latest development on the matter, the European Parliament voted last month for an EU-wide plan to phase out animal testing entirely​ – a move set to add weight to the cosmetic industry’s fight to protect the existing sector-specific ban. The European Commission was due to respond to the MEP vote in the coming months.

Next week on October 18^th​, the OECD will run an online webinar​ detailing how the Defined Approaches on Skin Sensitisation​ guideline could be applied to chemical safety in EU member states.