The Epidermal Sensitization Assay (EpiSensA) is a next-generation, GLP-compliant method developed by the KAO Corporation. The EpiSensA offers a reliable, human-relevant method for assessing skin sensitization potential, enhancing our ability to provide New Approach Methodologies (NAMs)-based solutions that address industry challenges. The EpiSensA quantifies the changes in the expression of genes associated with the activation of keratinocytes and cytoprotective pathways, corresponding to the second key event (KE-2) in the skin sensitization Adverse Outcome Pathway. The fold induction of four marker genes: ATF3, GCLM, DNAJB4, and IL-8, is analyzed through RT-qPCR.
The EpiSensA has been adopted by the OECD and included in Test Guideline 442D. Utilizing a reconstructed human epidermis (RhE) model, this assay effectively assesses a broad spectrum of chemicals, including lipophilic materials, pre-haptens, pro-haptens, finished products, and other substances that have traditionally been difficult to test. The use of a 3D tissue construct offers a more physiologically relevant model that closely mimics human tissue, enhancing the accuracy and reliability of sensitization assessments. IIVS brings nearly 30 years of experience in GLP-compliant in vitro testing to this new option for our sponsors.
IIVS performs the EpiSensA as part of an Integrated Testing Strategy in combination with other NAMs – such as KeratinoSens™, h-CLAT, and DPRA – to assess the skin sensitization potential of chemicals based on the Defined Approaches outlined in OECD Guideline 497.
