The JRC's European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) has published its recommendation on the use of non-animal approaches for skin sensitisation (allergy) testing. This document builds on the progress made in the area since the publication of the EURL ECVAM strategy in 2013 and provides EURL ECVAM views on the latest two methods for skin sensitisation, the LuSens and the U-SENS™, peer-reviewed by the EURL ECVAM Scientific Advisory Committee (ESAC) and on Defined Approaches which are based on the integration of different kinds of non-animal data.
As communicated in its strategy of 2013 (1) EURL ECVAM has been committed to play a leading role in the definition of international standards for assessing chemicals for their potential to elicit skin allergic responses. Three recommendations were issued by EURL ECVAM on non-animal methods for skin sensitisation testing, the DPRA, the KeratinoSensTM and the h-CLAT. A major achievement was the OECD adoption of these first three in vitro methods (OECD Test Guidelines 442C, 442D and 442E) based on key chemical and biological mechanisms of the process that leads to development of skin allergies. Following independent peer review by the EURL ECVAM Scientific Advisory Committee (ESAC)(2),(3) EURL ECVAM now supports the use of two additional methods, the LuSens and the U-SENS™ when used in combination with other relevant information.
Since none of the regulatory adopted methods provides the same level of information as the traditional animal tests, a number of defined approaches, i.e. approaches based on the use of different type of non-animal data, have been proposed for the identification of chemicals that may cause skin allergy. On behalf of the European Commission, the JRC's EURL ECVAM led the development of international guidance on the harmonised reporting of these approaches (4).
The defined approaches for skin sensitisation have comparable performance to the standard animal test, the Local Lymph Node Assay (LLNA), for identifying potential skin allergens. In addition some of them provide useful information to distinguish between strong and weak sensitisers. In the light of this evidence EURL ECVAM recommends these defined approaches be used where applicable and adequate instead of LLNA data or together with the animal data if these are already available. EURL ECVAM recognises the need to further evaluate the existing defined approaches in view of their possible translation into international standards to promote a global harmonised approach to the evaluation of chemicals for their skin sensitisation potential and further reduce the number of animal used for this purpose.
Read more in: Casati Silvia, Zuang Valérie, Whelan Maurice "EURL ECVAM Recommendations on the use of non-animal approaches for skin sensitisation", EUR 28553 EN, Publications Office of the European Union, Luxembourg, 2017, ISBN 978-92-79-67786-1, doi:10.2760/588955, JRC106410.
(1) EURL ECVAM Strategy for Replacement of Animal Testing for Skin Sensitisation Hazard Identification and Classification, https://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-strategy-papers/strat-sk…
(2) ESAC Opinion on the BASF-coordinated Performance Standards-based validation of the LuSens test method for skin sensitisation testing, https://ec.europa.eu/jrc/en/publication/esac-opinion-basf-coordinated-p…
(3) ESAC Opinion on the L'Oréal-coordinated study on the transferability and reliability of the U-SENS™ test method for skin sensitisation testing, https://ec.europa.eu/jrc/en/publication/esac-opinion-lor-al-coordinated…
- Dátum uverejnenia
- 3 máj 2017