KeratinoSens™ OECD 442D Skin Sensitisation Testing
SERVICE INFORMATION
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 guideline | OECD 442D |
| Adverse Outcome Pathway Key Event | Number 2 – activation of keratinocytes |
| What is being assessed | Activation of the Keap1-Nrf2-antioxidant/electrophile response element (ARE)-dependent pathway – using a luciferase gene reporter assay. |
| Why is this important | Activation of this inflammatory response pathway is a precursor event to dendritic cell activation and T-cell proliferation, resulting in allergenicity |
| Test System | KeratinoSensTM – 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 chemical | In vivo classification | EC1.5 | IC50 | KeratinoSensTM classification | Classification correct |
| 2,4-Dinitrochlorobenzene | Sensitiser (extreme) | Sensitiser | |||
| 4-methylamino sulfate | Sensitiser (strong) | Sensitiser | |||
| Methyldibromo glutaronitrile | Sensitiser (strong) | Sensitiser | |||
| 2-mercapto benzothiazole | Sensitiser (moderate) | Sensitiser | |||
| Ethylene glycol dimethacrylate | Sensitiser (weak) | Sensitiser | |||
| Cinnamyl alcohol | Sensitiser (weak) | Sensitiser | |||
| Glycerol | Non-sensitiser | Non-sensitiser | |||
| Lactic acid | Non-sensitiser | Non-sensitiser | |||
| Salicylic acid | Non-sensitiser | Non-sensitiser | |||
| Isopropanol | Non-sensitiser | Non-sensitiser | |||
