Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
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 did not raise a structural alert for mutagenicity (outside model's domain in Leadscope, negative prediction in DEREK, no findings in VITIC) [Result-Collected, March 2019]. Thus, a mutagenic potential is not concluded for the substance.
Justification for classification or non-classification
Based on in silico assessment and according to Regulation (EC) No. 1272/2008 (CLP) no classification is warranted for the substance for germ cell mutagenicity.
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.
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