Assessment factors to derive DNELs


The REACH TGD “Guidance on information requirements and chemical safety assessment’ Chapter R.8 proposes a tiered and systematic approach for the delineation of DNELs (and DMELs) including the application of assessment factors (AF) for extrapolation from animal data to man. Recently, guidance for AF based on human data was added. Building on this guidance, an ECETOC Task Force prepared additional scientific arguments and pragmatic recommendations for substances on which relevant information was available. The approaches developed were presented at a workshop that took place on 25th March 2010 in Barza d’Ispra, Italy.


The ECETOC guidance was demonstrated by a number of case studies. A parallel project carried out by the Fraunhofer Institute for Toxicology and Experimental Medicine for the detergent’s industry initiative ERASM (Environmental Risk Assessment and Management) was also presented. 55 participants, 8 of which came from regulatory authorities, discussed the proposals made and assessed where the science could be further developed in support of the implementation of REACH.

Conclusions and recommendations

The outcome of the workshop was summarised in Workshop Report No. 20 and the feedback received was taken into account in the final ECETOC Technical Report. (See Workshop Report No.20 and Technical Report No.110).