Our advice
Determining DMELs

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FIC1457 V1 Archive

Our advice


Determining DMELs

Author : Alain LOMBARD

Publication date: February 10, 2015 | Lire en français

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4. Our advice

4.1 Pay particular attention to DMEL bypassing

DMELs are binding on the manufacturer, who, on the basis of elements selected from the toxicological database, determines a value for workers and the general population, which he assumes presents a limited and acceptable risk in different exposure situations for the target organs defined by toxicology studies.

Choose the study that represents a critical effect in animals that can be transposed to humans, and the reference value (NOAEL, LOAEL, BMD, T25) from which you start.

Similarly, choose FAs that are suited to the exposure situation foreseeable in humans.

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