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SkinEthic™ HCE Eye Irritation Test

Topic : Eye irritation

Test Method Number: TM2015-03 (EU)
Short Name of TM: SkinEthic HCE EIT
Submission received on: Tuesday, October 27, 2015
Responsible Organisation: EURL ECVAM - European Union
Stage of Submission: Not applicable
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Recommendation: Drafting
Stage of Regulatory acceptance/Standards: Revision of existing regulatory standard/guideline
General Comments: External validation performed. Report submitted for peer-review as full test submission.

Method Description

The SkinEthic™ Human Corneal Epithelium (HCE) Eye Irritation Test (EIT) method, a reconstructed human cornea-like epithelium  (RhCE) consisting of a multilayered epithelium prepared from immortalized human corneal epithelial cells, for in vitro assay of eye damage/eye irritation potential. It constitutes a three dimensional structure which reproduces the multi-layer organization of the human cornea. The tissues are exposed to the test chemicals according to two possible protocols, depending on the physical state of the test chemical either solid "EITS" protocol, or liquid "EITL" protocol. Cell viabilities (MTT assay) are derived as eye damage measurements of the treated tissues.

The SkinEthic™ HCE was first sponsored (TM2008-09) for validation as alternative to the traditional in vivo rabbit eye test method (OECD TG 405) together with EpiOcularTM EIT (TM2008-10), in December 2008. The test method was unable to comply fully...

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Track Approval Status

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    Regulatory acceptance/Standards
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