OECD 442D KeratinoSens™ Services



The KeratinoSensTM assay is used to assess the second key event of the skin sensitisation adverse outcome pathway – activation of keratinocytes. It does this by measuring the expression of a luciferase gene reporter gene for the ARE-dependent pathway.

KeratinoSensTM protocols have been validated and laboratory proficiency under OECD 442D established at Gentronix, with services available in both GLP and non-GLP formats.

OECD guidelineOECD 442D
Adverse Outcome Pathway Key EventNumber 2 – activation of keratinocytes
What is being assessedActivation of the Keap1-Nrf2-antioxidant/electrophile response element (ARE)-dependent pathway – using a luciferase gene reporter assay.
Why is this importantActivation of this inflammatory response pathway is a precursor event to dendritic cell activation and T-cell proliferation, resulting in allergenicity
Test SystemKeratinoSensTM – modified HaCaT human keratinocytes, which express Nrf2/ARE-luciferase reporter.
Cytotoxicity estimated using MTT.
Test Item Requirements 1 g

KeratinoSensTM OECD 442D Proficiency Data

Gentronix results within OECD 442D reference range?Gentronix Results
Test chemicalIn vivo classificationEC1.5 IC50KeratinoSensTM classificationClassification correct
2,4-DinitrochlorobenzeneSensitiser (extreme)Sensitiser
4-methylamino sulfateSensitiser (strong)Sensitiser
Methyldibromo glutaronitrileSensitiser (strong)Sensitiser
2-mercapto benzothiazoleSensitiser (moderate)Sensitiser
Ethylene glycol dimethacrylateSensitiser (weak)Sensitiser
Cinnamyl alcoholSensitiser (weak)Sensitiser
Lactic acidNon-sensitiserNon-sensitiser
Salicylic acidNon-sensitiserNon-sensitiser

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