2. How do you establish a DNEL?
First of all, the toxicological profile of the substance must be established and all relevant data collected. The most relevant and valid studies should then be selected (Klimisch, see Criteria for determining the rating of a study (Tool Criteria for determining the rating of a study. Adapted from Klimisch et al (1997) and Rosner (1994) )).
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How do you establish a DNEL?
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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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