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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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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