The sensitivity of the KeratinoSens™ assay to evaluate plant extracts: a pilot study.

Several tests to assess skin sensitization hazard are in peer-review for pre-validation. These tests, as well as the animal tests they aim to replace, were developed (and validated) for the testing of pure substances. However, in the cosmetic field, active ingredients are often mixtures from natural sources. It is therefore important to understand which tests could be used to evaluate their safety. Here we describe a proof-of-concept study to test whether the KeratinoSens (TM) assay is able to detect sensitizing constituents within botanical mixtures. Four extracts were spiked with different doses of the sensitizers citral, cinnamic aldehyde and isoeugenol. The tested extracts were negative in the test whereas they became positive in most cases when spiked with the sensitizers. Analysis of the results from the samples spiked with different doses allowed the determination of the minimal level of sensitizers being detectable. The contribution to sensitization potential of doses of 2% and above of the spiked sensitizers were reliably detected. There were limitations for an extract with high cytotoxicity, in which case detection of the artificially spiked sensitizers proved difficult. This study gives a proof of principle for testing of mixtures in the KeratinoSens (TM) assay and indicates how sensitive the assay is to detect minor components with sensitizing potential. (C) 2013 Elsevier Ltd. All rights reserved.