4. Our advice
4.1 Pay particular attention to the derivation of DNELs
DNELs are binding on the manufacturer, who uses the elements selected from the toxicological database to determine a value – for workers and the general population – which he assumes to be risk-free in different exposure situations for the target organs defined by toxicology studies (acute risks, long-term risks, reprotoxicity, carcinogenicity, etc.).
Also select the study that represents a critical effect in animals that can be transposed to humans, and the reference value (NOAEL, LOAEL, BMD) 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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