Registration Dossier

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. According to the ICH M7 (on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk) in which the proposed use of (Q)SAR predictions as a substitute for an experimental Ames test is recommended, the results of in silico prediction of genotoxicity are the basis for assessing the possible DNA reactivity of the substance.

With regard to the results of a prediction models (DEREK, CASE Ultra, VITIC) the substance did not raise a concern with respect to possible mutagenicity [Wichard J., BAYER Report PH-37524 dated 05 August 2013].

Justification for classification or non-classification

Based on the available data for the test item no classification for germ cell mutagenicity according to Regulation (EC) No. 1272/2008 (CLP) is required.