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EC number: 676-349-3
CAS number: 34368-52-0
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, Leadscope,
VITIC) the substance did not raise a concern with respect to possible
mutagenicity [personal communication: 11 September 2019].
Based on the available data for the test item no classification for germ
cell mutagenicity according to Regulation (EC) No. 1272/2008 (CLP) is
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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