Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

There are multiple reliable studies with losartan potassium on mutagenicity, including in vitro and in vivo, all of which have a negative result. Therefore, it can be concluded by read-across that losartan free acid is also non-genotoxic.

Justification for selection of genetic toxicity endpoint
in vivo study

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The analogue substance, and therefore also losartan free acid, does not meet the criteria for classification as a mutagen according to DSD or CLP regulations.