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Epidermal Skin Test 1000

Topic : Skin irritation

Test Method Number: TM2009-09 (EU)
Short Name of TM: EST-1000/epiCS
Submission received on: November, 2009
Responsible Organisation: EURL ECVAM - European Union
Stage of Submission: Assessment of Full submission
Stage of Validation: Finalised
Stage of Peer-review: Finalised
Stage of Regulatory acceptance/Standards: Adopted
General Comments:

ESAC peer review requested additional testing

Method Description

The epiCS RHE SIT test method addresses the skin irritation endpoint.  It intends to make predictions of skin irritancy potential on the basis of the United Nations (UN) Global Harmonized Systems for classification and labelling (GHS). 

The test system is composed of Reconstructed human Epidermis (RhE) tissues. This model constitutes a three dimensional structure which reproduces the typical multi-layer cell organization of the epidermis. The tissues are exposed to the test chemicals during 20 minutes. This is followed by a post-exposure period of 24±2 hours in order to derive the cell viability of the tissues.

Mitochondrial dehydrogenases of living cells are able to reduce the MTT reagent into blue formazan. The Sterlab RHE SIT protocol measures the optical density (OD) of the blue formazan in the treated tissues. The OD is normalised to the one of the negative control in order to express cell viability values in percentages.


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Track Approval Status

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    Regulatory acceptance/Standards
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