KeratinoSensTM and LuSens are cell-based reporter gene assays that model the second key event in the Adverse Outcome Pathway for Dermal Sensitization, namely keratinocyte activation. The assays measure the induction of a stably transfected luciferase gene under the control of the antioxidant response element (ARE) derived from the human AKR1C2 or rat NQO1 gene.
The results of these assays 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 developers of these assays to ensure that they are transferable, reproducible, and predictive as compared to the historical animal data. Following extensive review of the validation data, both assays have received endorsements by the European Commission on the Validation of Alternative Methods (ECVAM), and are performed according to an internationally-recognized test guideline (OECD 442D).
- Human Keratinocyte Cell Line (HaCaT) Model
- At least two independent runs performed
- Compatible with fully soluble, or stable homogenous suspensions of test chemicals
- IIVS has considerable experience with testing mixtures and identifying sensitizers in complex matrices
- Cytotoxicity assessment included
- Internationally recognized (OECD) test guideline