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

Mutagenicity
In vitro Micronucleus Test
3 Rs Category :  Reduction
Type of Method :  In vitro
Validation Statement :  17/11/2006 Recommended post-validation work for development of a standardised test protocol, define performance standards and carry-out several follow-up post-validation activities and studies in collaboration with OECD.
Comment :  In vitro test that improves the efficiency of an existing in vitro testing battery thus reducing the need of confirmatory in vivo testing.
Further studies are led by UK in collaboration with ECVAM in the frame of OECD.
Already mentioned in REACH Guidance on "Information Requirements and Chemical Safety Assessment" (May 2008) ECHA
Status of adoption in EU :  Mentioned in Regulation 1907/2006/EC (Official Journal L 396 2006).
The OECD TG will be immediately applicable when adopted.
Stage 2.
Corresponding OECD TG :  Draft TG 487, on-going.
Adoption, expected by end 2008.
Immediate adoption in EU foreseen.
Status of adoption by OECD :  OECD