Applying non-animal strategies for assessing skin sensitisation report from an EPAA/cefic-LRI/IFRA Europe cross sector workshop, ECHA helsinki, February 7th and 8th 2019

Regul Toxicol Pharmacol. 2019 Dec:109:104477. doi: 10.1016/j.yrtph.2019.104477. Epub 2019 Oct 3.

Abstract

Four years on since the last cross sector workshop, experience of the practical application and interpretation of several non-animal assays that contribute to the predictive identification of skin sensitisers has begun to accumulate. Non-animal methods used for hazard assessments increasingly are contributing to the potency sub-categorisation for regulatory purposes. However, workshop participants generally supported the view that there remained a pressing need to build confidence in how information from multiple methods can be combined for classification, sub-categorisation and potency assessment. Furthermore, the practical experience gained over the last few years, highlighted the overall high potential value of using the newly validated methods and testing strategies, but also that limitations for certain substance/product classes may become evident with further use as had been the case with other new regulatory methods. As the available information increases, review of the data and collated experience could further determine strengths and limitations leading to more confidence in their use. Finally, the need for a substantial and universally accepted dataset of non-sensitisers and substances of different sensitising potencies, based on combined human and in vivo animal data for validation of methods and test strategies was re-emphasised.

Keywords: Defined approaches; Hazard classification; In vitro alternatives; Integrated approaches to testing and assessment; Integrated testing strategies; Potency sub-categorisation; Skin sensitisation.

MeSH terms

  • Animal Testing Alternatives*
  • Congresses as Topic*
  • Datasets as Topic
  • Europe
  • Research Design / standards*
  • Skin / drug effects*
  • Skin / immunology
  • Skin Tests / methods
  • Skin Tests / standards
  • Toxicity Tests / standards*