As a substantial number of the substances have already been tested for some of the methods, it is expected that the remaining data gaps will be filled soon. This will allow re-assessment of already proposed testing strategies, e.g. by Bauch et al., 2012, Gomes et al., 2012, Nukada et al., 2012, Natsch et al., 2013 and Jaworska et al., 2013, with new data. Once the data for the eight test methods will be available, a testing strategy will be composed addressing the specific purposes and needs as described above. Driven Cyclopamine by the mechanistic understanding and supported by data analysis specialists, data mining and other statistical tools will be used to combine test method data in an objective and transparent

way to selleck chemical obtain a predictive testing strategy that will be made publicly available. Predictive performance will be assessed correlatively/probabilistically against the reference human and LLNA data or a combination thereof. Although efficiency and other factors, such as availability or duration, may – at least at this stage – not be accounted for, it is nevertheless expected

that the strategy will comprise a limited number of test methods. In the third phase of the framework, applicability domain issues specifically relevant for substance used by cosmetic industry will be addressed. It is anticipated that for inherently problematic substance types, such as natural extracts, dyes or polymers, further data may be required Protein kinase N1 in order to provide sufficient evidence that the testing strategy works for these substance types or to optimise the adaptation of the strategy. The resulting non-animal testing strategy for skin sensitisation potency predictions will be combined with bioavailability and skin metabolism data, exposure consideration and in exceptional cases with data from T cell activation assays, to satisfy the ultimate goal of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients. The authors declare that there are no conflicts of interest. Transparency document.

We would like to thank Pierre Aeby for his support of the method evaluation leading to the workshop. Furthermore, we would like to thank Silvia Casati (EC, EURL-ECVAM) for her active participation in the workshop. “
“Cutaneous malignant melanoma (CMM) presents significant morbidity and a high mortality rate and is the most dangerous of all common skin cancers because of its propensity to metastasize. The number of melanoma cases worldwide is increasing faster than any other cancer. In contrast to other types of cancer, CMM frequently affects young individuals, with a mean age of 50 years (Ferrari et al., 2008). The treatment of patients with advanced melanoma remains an important issue to be investigated. The same chemotherapies that are effective in numerous types of cancer are largely ineffective in melanoma (Huncharek et al., 2001).