The European Chemicals Agency (ECHA) has released updated guidance on the use of OECD Test Guidelines (OECD TG 442 C–E) and Defined Approaches (OECD GL 497) for Skin Sensitisation, further strengthening the transition toward non-animal testing under REACH.
The updated guidance clarifies when in chemico, in vitro, and in silico approaches can be used to meet regulatory information requirements. Importantly, ECHA confirms that these methods are now applicable to a wider variety of substances, including those with low solubility, which historically posed challenges for non-animal assessment.
This update reflects progress in understanding the adverse outcome pathway for skin sensitisation and encourages industry and regulators to increasingly adopt New Approach Methodologies (NAMs) for hazard identification and safety assessment.
The revised guidance also provides detailed explanations of key events, test methods, and applicability considerations to support informed decision-making by stakeholders.
