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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).
EpiSkin™
3 Rs Category :  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 under GHS (ESAC): 09/04/2009; updated 08/07/2009.
3) Performance Standards for in vitro skin irritation testing (ESAC): 09/07/2009.
Comment :  To be used in the frame of a testing strategy for corrosion/irritation.
Referenced in REACH Guidance on "Information Requirements and Chemical Safety Assessment" (May 2008) ECHA.
The EpiSkinTM test method is the primary reference method of the Performance Standards.
The Performance Standards (updated acc. to GHS) were published on 24/08/2009.
Status of adoption in EU :  Adopted in 2009.
1st Published in EC Regulations / Updates :  Directive 761/2009/EC (Official Journal L 220 2009)
Text of EU method :  B.46
Corresponding OECD TG :  TG 439
Status of OECD adoption :  OECD