Sensitivity of KeratinoSensTM and h-CLAT for detecting minute amounts of sensitizers to evaluate botanical extract

Cosmetic ingredients are often complex mixtures from natural sources such as botanical extracts that might contain minute amounts of constituents with sensitizing potential. The sensitivity of in vitro skin sensitization test methods such as KeratinoSensTM and h-CLAT for the detection of minute amou...

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Bibliographic Details
Published in:Journal of toxicological sciences 2019, Vol.44(1), pp.13-21
Main Authors: Nishijo, Taku, Miyazawa, Masaaki, Saito, Kazutoshi, Otsubo, Yuki, Mizumachi, Hideyuki, Sakaguchi, Hitoshi
Format: Article
Language:eng ; jpn
Subjects:
Botanical extract
Constituents
Detection limit
Dilution
h-CLAT
In vitro methods and tests
KeratinoSensTM
LLNA
Sensitivity
Sensitivity analysis
Sensitizing
Skin
Skin sensitization
Skin tests
Test methods
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Summary:Cosmetic ingredients are often complex mixtures from natural sources such as botanical extracts that might contain minute amounts of constituents with sensitizing potential. The sensitivity of in vitro skin sensitization test methods such as KeratinoSensTM and h-CLAT for the detection of minute amounts of sensitizer in mixtures remains unclear. In this study, we assessed the detection sensitivity of the binary test battery comprising KeratinoSensTM and h-CLAT for minute amounts of sensitizers by comparing the LLNA EC3 (estimated concentration of a substance expected to produce a stimulation index of 3) values to the minimum detection concentrations (MDCs) exceeding the positive criteria for each of the two in vitro test methods. 146 sensitizers with both sets of in vitro data and LLNA data were used. MDC values for KeratinoSensTM and h-CLAT were calculated from exposure concentrations exceeding positive criteria for each in vitro test method (EC1.5 and minimum induction thresholds, respectively). The dilution rate used to expose culture medium was also considered. For 86% of analyzed sensitizers, the in vitro test methods showed MDC values lower than LLNA EC3 values, suggesting that the binary test battery with KeratinoSensTM and h-CLAT have greater sensitivity for detection of minute amounts of sensitizer than LLNA. These results suggest the high applicability of KeratinoSensTM and h-CLAT for detecting skin sensitizing constituents present in botanical extract.
ISSN:0388-1350
1880-3989
DOI:10.2131/jts.44.13