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

No 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 no structural alert for mutagenicity (Negative prediction in DEREK; Leadscope: an alerting N-bis-amino-ethyl moiety was detected, this prediction was refuted based upon a shared alert with a known negative structurally similar substance; no findings in VITIC) [Result, August 2019]. Thus, no mutagenic potential is concluded for the substance.

Justification for classification or non-classification

Based on an in silico assessment no mutagenic potential is concluded for the substance.