Strategy for skin sensitisation hazard identification and classification
In March 2013, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) released its strategy on how to achieve an animal-free solution for assessing chemicals for skin sensitisation.
The strategy went through extensive consultation with its advisory and stakeholder bodies (*) and aims to satisfy regulatory requirements within various pieces of EU legislation. ECVAM, in collaboration with Cosmetics Europe, EPAA (the European Partnership for Alternative Approaches to Animal Testing) and international partners will focus its efforts on the development of one or more non-animal Integrated Testing Strategies (ITS) for identification and classification of skin sensitisers according to the Globally Harmonised System of Classification and Labelling for chemicals (GHS).
Successful implementation of this strategy in the coming years will satisfy, for example, information requirements under REACH and CLP (Classification Labelling and Packaging) and will also help address the safety assessment of cosmetic ingredients. This will result in a significant reduction in the use of animals for regulatory purposes.
In the absence of validated and regulatory accepted alternative test methods, the assessment of the skin sensitisation potential of chemicals currently relies on animal testing. Progress in the development of alternative methods has been prompted by the increasing knowledge on the key mechanisms of the skin sensitisation pathway, as recently documented in the OECD Adverse Outcome Pathway (AOP) for skin sensitisation. This progress is reflected in the numerous submissions of alternative test methods for skin sensitisation that ECVAM has received.
A key element of the strategy is that the European Commission, through EURL ECVAM, will aim at taking a leading role within the OECD to facilitate a globally accepted alternative approach for skin sensitisation hazard identification and classification.
Skin sensitisation is the toxicological endpoint associated with chemicals that have the intrinsic ability to cause skin allergy in humans, resulting in a disease called Allergic Contact Dermatitis (ACD) which is caused by a number of complex interactions at molecular, cellular and tissue levels. The assessment of the skin sensitisation potential represents an important component in the safety evaluation of substances, especially those used in consumer products - e.g. cosmetics and detergents.
(*) ECVAM Scientific Advisory Committee (ESAC), ECVAM's consultation body on the Preliminary Assessment of Regulatory Relevance of test methods (PARERE), theECVAM Stakeholder Forum (ESTAF) and the International Cooperation on Alternative Test Methods (ICATM).