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TSAR : Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals

Skin Irritation
B.46 In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test (RhE).
Original EpiDerm™
3 Rs Category :  Partial Replacement
Type of Method :  In vitro
Statement on scientific validity and
potential use
 :  1) Scientific validity of test method (ESAC): 27/04/2007.
2) Performance Standards for in vitro skin irritation testing (ESAC): 09/07/2009.
Comment :  The original EpiDerm™ test method has the capacity to partially replace the classical in vivo Draize skin irritation test since it allows to reliably identify skin irritant substances only. However, following the statement of scientific validity, the test method was modified and validated as a full replacement in the context of an "Update Validation Study" (c.f. TSAR entry on "Modified EpiDerm™ SIT").
The Performance Standards (updated acc. to GHS) were published on 24/08/2009.
Status of adoption in EU :  Not included and not foreseen.
Text of EU method :  B.46
Status of OECD adoption :  Not included and not foreseen.