Human Reconstructed Corneal Epithelium (HCE) Eye Irritation test

Topic: Serious eye damage/Eye irritation

Test Method Number:
TM2008-09 (EU)
Short Name of TM:
SkinEthic HCE
Year received:
2008
Responsible Organisation:
General Comments:
This test method was unable to comply fully with the acceptance criteria set by the validation management group. A revised SkinEthic™ HCE EIT test method was re-submitted for assessment by EURL ECVAM and formal ESAC peer review in October 2015 (See TM2015-03, SkinEthic-HCE-EIT).

Method Description

The purpose of this assay was to evaluate the ocular irritation potential of chemicals for European Union labelling and classification, in order to discriminate non irritants from irritants, and to be used as an alternative to the traditional in vivo rabbit eye test method (OECD TG 405). The test uses the SkinEthic™ HCE model, a reconstructed human cornea-like epithelium (RhCE) consisting of a multilayered epithelium prepared from immortalized human corneal epithelial cell. It constitutes a three dimensional structure which reproduces the multi-layer organization of the human cornea. The test consists of a topical exposure of the neat test chemicals onto the Human Corneal Epithelium model HCE, followed by cell viability measurement.

 

Track Approval Status

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