Title: EURL ECVAM Recommendation on the KeratinoSensTM assay for skin sensitisation testing
Authors: CASATI SilviaGRIESINGER ClaudiusWORTH AndrewWHELAN Maurice
Publisher: Publications Office of the European Union
Publication Year: 2014
JRC N°: JRC87551
ISBN: 978-92-79-34795-5
ISSN: 1831-9424
Other Identifiers: EUR 26427
OP LB-NA-26427-EN-N
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC87551
DOI: 10.2788/52914
Type: EUR - Scientific and Technical Research Reports
Abstract: Identification of the skin sensitisation hazard of chemicals has traditionally relied on the use of animals. Progress in the development of alternative methods has been prompted by the increasing knowledge of the key biological mechanisms underlying this human health effect, as documented by the OECD's recent report summarising the key biological events leading to skin sensitisation ("Adverse Outcome Pathway" (AOP) for skin sensitisation). Within this AOP the activation of cellular signalling pathways, such as the Keap1-Nrf2- antioxidant/electrophile response element (ARE)-dependent pathway, known to play a relevant role in keratinocytes’ responses to skin sensitisers, is postulated to be a key event. Therefore, test methods able to provide information on the ability of a chemical to activate this or other relevant pathways in keratinocytes, may contribute to skin sensitisation hazard and safety assessment. The KeratinoSensTM test method measures ARE-Nrf2 activation through a luciferase reporter gene. The test method has undergone a validation study addressing mainly the test method’s transferability and within- and between-laboratory reproducibility. Following independent scientific peer review by EURL ECVAM’s Scientific Advisory Committee (ESAC) and having considered the input from regulators, stakeholders, international partners and the general public, EURL ECVAM concluded that the KeratinoSensTM may prove a useful component of integrated approaches such as Weight of Evidence (WoE) or Integrated Testing Strategies (ITS) for skin sensitisation hazard assessment. In addition to this, the KeratinoSensTM may also be able to contribute to the assessment of sensitising potency, e.g. by supporting sub-categorisation of sensitisers according to UN GHS. However it is recognised that further efforts are required to explore how KeratinoSensTM data may contribute to potency assessment.
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