1. What are DMELs?
Establishing DMELs is an important step in the overall process of assessing the hazards of a chemical substance. It is the logical follow-up to the studies carried out to determine the substance's ADME, and to the results of short-, medium- and long-term "in vitro and in vivo" toxicological studies.
1.1 Definition
Derived Minimal Effect Levels (DMELs) are the values to be defined under the European REACh regulation for chemicals whose effects on humans do not allow a threshold to be established.
These are reference values based on a relative risk of cancer, which are used to implement appropriate risk management measures for human populations, including workers.
A DMEL differs from a DNEL in that the substance's...
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Bibliography
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ECETOC: Guidance on Assessment Factors to Derive a DNEL; Technical Report N°110, 2010.
ECHA : Guidance on information requirements and chemical safety assessment , Chapter R.8 : Characterisation of dose [concentration]-response for human health, version 2.1, 2012.
ECHA : How to prepare toxicological summaries in IUCLID and how to derive...
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