Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
no study available

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Testing data are available for the substance.


 


In silico assessments on the mutagenic potential using (Q)SAR methologies according to ICH M7 Guideline are accepted in the pharmaceutical context by regulators as valid tools for detecting DNA-reactive substances (ICH=International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; M7 Guideline is on "Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk").


With regard to the prediction models used (Leadscope, DEREK, VITIC) the substance raised a structural alert for mutagenicity [Class 3 Alerting structure; Result, March 2019]. Thus, without further data, a mutagenic potential cannot be excluded for the substance.

Justification for classification or non-classification

Data lacking - without further data, a mutagenic potential cannot be excluded for the substance