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EC number: 211-748-4 | CAS number: 693-33-4
The human skin sensitisation potential of ColaTeric LAB-70UP; (Lauryl betaine (C12)) was assessed using validated in vitro method: the KeratinoSensTM test to determine keratinocyte activation. The method was adapted to animal product-free conditions by XCELLR8 and reference chemicals described in the guideline and in the performance standards were used to confirm the reliability, accuracy, sensitivity and specificity values. The adapted method showed full concordance with the Validated Reference Method (VRM) – the KeratinoSensTM standard protocol. Clarification from the European Chemicals Agency (ECHA) says that data using the adapted method may be used in REACH submissions, provided that the Performance Standards data, demonstrating equivalence with the VRM, is included in the dossier.
In this study, ColaTeric LAB-70UP; (Lauryl betaine (C12) was classified as a sensitiser to human skin.
The sensitisation potential of was quantified by calculating 2 parameters known as the EC1.5 and the IMAX value.
Lauryl betaine caused luciferase induction >1.5 in all 3 repetitions. The respective EC1.5 value were calculated as 31.72μg/ml for repetition 1; 61.87 μg/ml for repetition 2 and 9.09μg/ml for repetition 3. Therefore, ColaTeric LAB-70UP; (Lauryl betaine (C12)) was classified as a sensitiser.
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