Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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. 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 prediction models (DEREK, MULTICASE; VITIC; CASE Ultra) the substance did not raise a concern with respect to possible mutagenicity [personal communication: October 2014]. This was again confirmed by the result ( "No structural alerts, or alerting structure with sufficient data to demonstrate lack of mutagenicity or carcinogenicity. Treat as non-mutagenic impurity."; personal communication March 19, 2018) of a recently repeated in silico assessment using the actual versions of the prediction models (Derek, VITIC, Leadsope).

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.