AI for small nitrosamines not listed in EMA, FDA or Health Canada

[Yosukemino]

Hi, @elenaly.

In addition to @manasipkane 's answer, the following @David 's post may help you. I think you can use not harmonic but each TD 50 for AI calculation.

NDEA AI Limit 26.5ng/day?

A few thoughts on these discussions: The TD50s used for limit setting are typically the rodent TD50s, firstly since that is the standardised carcinogenicity assay (thus that exceptionally potent primate result for NDEA is ignored from the dataset), and secondly since rodent TD50s were used for the TTC and CoC initial development by Kroes, Cheeseman and co-workers. Additionally, a primate assay is less likely to be lifetime, due to longer lifespans, would use fewer animals for cost and ethics …