1. What are DNELs?
1.1 Definition
Derived Non Effect Levels (DNELs) are the limit values to be set under the European REACh regulation for chemical substances whose threshold effects have been defined in toxicology studies. These are the exposure levels for a chemical substance below which human populations, including workers, should not be affected.
For non-threshold substances (genotoxic, carcinogenic), a semi-quantitative assessment (Derived Minimal Effect Level – DMEL) will be defined.
In the absence of data, a qualitative assessment based on expertise will be used.
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What are DNELs?
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Bibliography
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Bibliography
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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