Reconstructed Human Epidermis Model Test

Topic: Skin irritation

Test Method Number:
TM2005-04 (EU)
Short Name of TM:
EpiSkin™ - RHE
Year received:
2005
Responsible Organisation:
Protocol(s)/SOP(s):
131
General Comments:

Method Description

The EpiSkin™ model is a three dimensional reconstructed human epidermis that, once established, comprises of a main basal, supra basal, spinous and granular layers and a functional stratum corneum (the outer barrier layer of skin).
The use of the model specifically for skin irritation testing involves the topical application of a test chemical followed by an assessment of cell viability, and specifically cytotoxicity (as measured via the MTT assay). Reductions in cell viability are then expressed as a % of the negative control. The % reduction is then used to predict the irritation potential of a chemical.
A substance is considered to be irritating to skin (i.e. categorised as R38) if tissue viability after exposure and post incubation (see protocol, below) is less than or equal to 50%. Cell viability above 50% is considered a marker of a chemical being a non-irritant.

Track Approval Status

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