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

Skin irritation and Corrosion
Artificial Skin Model (SkinEthic-RHE) for Skin Irritation
3 Rs Category :  Replacement
Type of Method :  In vitro
Validation Statement :  1) Scientific validity of test method (ESAC): 05/11/2008.
2) Performance under GHS (ESAC): 09/04/2009; updated 08/07/2009.
3) Performance Standards for in vitro skin irritation testing (ESAC): 08/07/2009.
The Performance Standards (updated according 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 :  Parallel work in the OECD TG Programme:
On-going development of a TG, led by the EC (ECVAM).
Expert meetings took place in October 2008 and June 2009.
Additional data and revised performance standards provided by the EC (ECVAM).
Adoption foreseen end 2009 or early 2010.
Status of adoption by OECD :  OECD