In Vitro Membrane Barrier Test Method for Skin Corrosion

Topic: Skin Corrosion

Test Method Number:
TM1998-01 (EU)
Short Name of TM:
Corrositex®
Year received:
1998
Responsible Organisation:
EURL ECVAM - European Union 
Protocol(s)/SOP(s):
116
General Comments:
In the 1990s, the Corrositex® method was evaluated on a number of occasions by agencies in the US. They concluded that in specific testing circumstances, the method would be useful as a stand-alone assay for evaluating skin corrosion potential.

Method Description

The Corrositex® method was originally established to predict the skin corrosivity potential of chemicals and to rank them according to their degree of corrosive effect. The assay is based on the determination of the time needed for a test material to pass through a biobarrier membrane. The membrane is a reconstituted collagen matrix with physical properties that are similar to rat skin.
The end-point is the time required to cause a colour change in an underlying 'chemical detection system'. The colour change is visually scored and therefore a subjective measurement (i.e. there is a potential variation in measurement outcomes due to operator variability).
The test method has received regulatory approval as a replacement of in vivo skin corrosivity tests (i.e. the Draize rabbit skin test) for specific classes of chemicals (i.e. acids, bases and certain derivatives) which meet the technical requirements of the assay.

Track Approval Status

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