The KeratinoSensTM assay is a cell-based reporter gene assay that models the second key event in the Adverse Outcome Pathway for Dermal Sensitization, namely keratinocyte activation. This approach measures the induction of luciferase under the control of the antioxidant response element (ARE) derived from the human AKR1C2 gene, and can be used in a Weight of Evidence approach as an alternative to animal testing methods for the purpose of hazard identification.
IIVS has participated in validation studies led by the assay developer Givaudan, a multi-national manufacturer of flavors and fragrances, to ensure that the assay is transferable, reproducible, and predictive as compared to the historical animal data. Following extensive review of the data by the European Commission on the Validation of Alternative Methods (ECVAM), the assay received an endorsement and the OECD followed with an internationally-recognized test guideline (OECD 442D).
- Human Keratinocyte Cell Line (HaCaT) Model
- Three independent assays performed to improve statistical significance
- Cytotoxicity assessment included
- Internationally recognized (OECD) test guideline