SENS-IS

Topic: Skin sensitisation

Test Method Number:
TM2011-11 (EU)
Short Name of TM:
SENS-IS
Year received:
2011
Responsible Organisation:
General Comments:
Under external validation

Method Description

The SENS-IS assay is a patent-protected gene expression-based test method proposed to discriminate between skin sensitisers, non-sensitisers and skin irritants by analysing the expression in Reconstructed human Epidermis (RhE) of a panel of 65 genes grouped in one gene set for irritancy (IRR) and two (SENS-IS and ARE) for sensitisation. In addition, the test method allows the classification of sensitisers into potency categories on the basis of the concentration of chemical needed to induce a positive response.

A test substance is classified as sensitiser on the basis of the number of overexpressed genes (compared to solvent control) measured by qRT-PCR in Episkin RhE tissues. The biomarkers have been selected starting with data mining, followed by treatment with either sensitisers or irritants in the LLNA model, further refined using qPCR analysis of suction blisters on human volunteers sensitised to Nickel or fragrance mix in a controlled clinical trial, and...

The SENS-IS assay is a patent-protected gene expression-based test method proposed to discriminate between skin sensitisers, non-sensitisers and skin irritants by analysing the expression in Reconstructed human Epidermis (RhE) of a panel of 65 genes grouped in one gene set for irritancy (IRR) and two (SENS-IS and ARE) for sensitisation. In addition, the test method allows the classification of sensitisers into potency categories on the basis of the concentration of chemical needed to induce a positive response.

A test substance is classified as sensitiser on the basis of the number of overexpressed genes (compared to solvent control) measured by qRT-PCR in Episkin RhE tissues. The biomarkers have been selected starting with data mining, followed by treatment with either sensitisers or irritants in the LLNA model, further refined using qPCR analysis of suction blisters on human volunteers sensitised to Nickel or fragrance mix in a controlled clinical trial, and final selection based on testing data in Episkin RhE tissues.

The test system used is the commercially available EpiskinTM, a 3D RhE obtained by culturing adult human keratinocytes on a collagen substrate to permit their terminal differentiation and the reconstruction of an epidermis with a functional stratum corneum. According to the test submitter, this model can take account of skin metabolism and skin penetration and should be widely applicable to testing of chemicals, including pre and pro-haptens, solids and liquids.

Track Approval Status

  •  
    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Step
Submission Show status
Validation Show status
Peer-review Show status
Recommendation
Regulatory acceptance/Standards