epiCS Skin Irritation Test

Topic: Skin irritation

Test Method Number:
TM2009-09 (EU)
Short Name of TM:
epiCS SIT
Year received:
2009
Responsible Organisation:
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.

Test...

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.

Test chemicals lead to a positive response when the cell viability values are below or equal to 50%, while a negative response is found when cell viability values are above 50%. On the basis of the UN GHS a positive response should be labelled as "Classified" whereas a negative response should be labelled as "Not Classified". A prediction as "Classified" means that the test chemical could be either a skin irritant or a skin corrosive.

The epiCS RHE SIT protocol is intended to be potentially used for the prediction of acute skin irritation in regulatory safety testing under the UN GHS, REACH, EU Classification, Labelling and Packaging of substances and mixtures (CLP) or Cosmetic Directive for chemicals. The OECD published an "Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Skin Irritation" which shows how proper interpretation of skin irritation and skin corrosion tests should be performed and how additional tests should be eventually conducted to evaluate the skin irritation and corrosion potential of chemicals. The ECHA published the "REACH Guidance on Information Requirements and Chemical Safety Assessment" which makes reference to this OECD IATA and includes a testing strategy based on it.

Track Approval Status

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