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LuSens Assay

Topic : Skin sensitisation

Test Method Number: TM2011-10 (EU)
Short Name of TM: LuSens
Year received: 2011
Responsible Organisation: EURL ECVAM - European Union '
Protocol(s)/SOP(s): 184
General Comments:

The Lu-Sens underwent an external catch-up validation study based on the performance standards for in vitro skin sensitisation ARE-NrF2 luciferase test methods (OECD 2015).

Method Description

The LuSens assay supports the discrimination between sensitizing and non-sensitizing chemicals. It is based on the same concepts as the OECD adopted KeratinoSens™.

The LuSens assay addresses one of the biological mechanisms described under key event 2 (events in keratinocytes) of the skin sensitization Adverse Outcome Pathway by measuring the activation of the Keap1-Nrf2-ARE pathway.

The Keap1-Nrf2-ARE regulatory pathway is reported to be a major regulator of cyto-protective responses to electrophile and oxidative stress by controlling the expression of detoxification, antioxidant and stress response enzymes and proteins. Small electrophilic substances such as skin sensitisers can act on the sensor protein Keap1 (Kelch-like ECH-associated protein 1), by e.g., covalent modification of its cysteine residue, resulting in its dissociation from the transcription factor Nrf2 (nucler factor-erythroid 12-related factor 2). The dissociated Nrf2 can...

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Track Approval Status

  • Submission
  • Validation
  • Peer-review
  • Recommendation
  • Regulatory acceptance/Standards
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