RHE IL-18 potency test for skin sensitization

Topic: Skin sensitisation

Test Method Number:
TM2012-05 (EU)
Short Name of TM:
RHE IL-18
Year received:
2012
Responsible Organisation:
General Comments:
Invitation to send a full submission

Method Description

The RHE IL-18 potency test for skin sensitization is an integration of two test methods covering epidermal inflammation and cytotoxicity with the aim to measure skin sensitizing potential and potency. It represents an update of the two-tiered approach, (2-TA; TM-2011-12).

The RHE-IL18 allows the quantification of the two readouts (IL-18 release and cytotoxicity) in the same test system (Reconstructed human Epidermis (RhE)). The skin sensitisation potential is tested based on the quantification of the release of intracellular pro-inflammatory IL-18 in keratinocytes by ELISA. Skin sensitiser potency is measured as inverse correlation of cell viability (expressed as EC50 value).

RHE IL-18 can be performed using commercially available RhE as well as in-house developed RhE.

Track Approval Status

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