4. Our advice
4.1 Pay particular attention to the derivation of DMELs.
DMELs commit the producer who, based on the elements he has selected from the toxicological database, determines a value for workers and the general population that he assumes presents a limited and acceptable risk in different exposure situations for the target organs defined by toxicological studies.
In addition, choose the study that represents a critical effect in animals that can be transposed to humans, as well as the reference value (NOAEL, LOAEL, BMD, T25) from which you are starting.
Similarly, choose AFs that are appropriate for the exposure situation that can be expected in humans.
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Bibliography
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Bibliography
ECETOC - Guidance on Assessment Factors to Derive a DNEL. Technical report No. 110 (2010).
ECHA - Guidance on information requirements and chemical safety assessment. Part E: Risk Characterization Version 3.0 (May 2016).
ECHA - How to prepare toxicological summaries in IUCLID and how to derive DNELs. Practical Guide 14, version 1 (2012)....
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