Dear C. Wybon,
thanx a lot for your fast response.
If i understand well, an acceptance intake for a nitroso-imidazole compound, for which no known mutagenicity data is available, should be set as 1500mcg/day or less.
So, we are in the section 7.5 of the guideline, where is written:
‘‘Although the principles of this guideline can be used, a case-by-case approach using e.g., carcinogenicity data from closely related structures, if available, should usually be developed to justify acceptable intakes for pharmaceutical development and marketed products.’’.