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KeratinoSens assay for the testing of skin sensitizers

Topic : Skin sensitisation

Test Method Number: TM2010-03 (EU)
Short Name of TM: KeratinoSens
Year received: 2010
Responsible Organisation: EURL ECVAM - European Union '
DB-ALM Protocol No.: 155
Stage of Submission: Assessment finalised
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Published
Stage of Regulatory acceptance/Standards: Adopted
General Comments:

The validation was performed externally between 2009 and 2010

Method Description

The KeratinoSens™ test method supports the discrimination between sensitizing and non-sensitizing chemicals. It 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 then activate ARE-dependent genes such as those coding for phase II...

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Track Approval Status

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    Regulatory acceptance/Standards
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