Practical Guide for reporting toxicological summaries for REACH

On 16 July 2012, the European Chemicals Agency (ECHA) published a Practical Guide for REACH registrants on how to report the toxicological summaries, including derivation of no-effect levels (DNELs) in IUCLID. The aim is to support registrants in their preparations for the 2013 deadline and to provide guidance on how to improve the overall quality of information in the chemical safety assessment of existing dossiers. The new Practical Guide 14, “How to prepare toxicological summaries in IUCLID and how to derive DNELs” supports registrants in correctly summarising the toxicological information for substances in section 7 of IUCLID 5.4. This includes the summaries for the different toxicological endpoints and the overall summary across all the endpoints. The document describes the generic workflow from entering the robust study summaries for the single endpoints to the determination of the scope of the exposure assessment. It specifically describes and exemplifies the data fields available for providing transparent DNELs. Entering complete and consistent information in IUCLID enables the automated generation of the corresponding sections in the chemical safety report, and provides a consistent starting point for exposure assessment and risk characterisation (if required). The Practical Guide is based on Chapter R.8 (DNEL Derivation) of the Guidance on Information Requirements and Chemical Safety Assessment. A copy of the new guide is available at:

ECHA, 18 July 2012 ; ;