Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-974-5 | CAS number: 12047-11-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo, other
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The uncertainties, which are arisen from the in vitro test results, would make desirable a verification by means of an in vivo test, as it is foreseen by the Regulation EC 1907/2006. However, toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance, making non reliable the validated in vivo mutagenicity tests. Indeed, B.11 (In Vivo Mammalian Bone Marrow Chromosome Aberration Test) and B.12 (In Vivo Mammalian Erythrocyte Micronucleus Test) sections of the Regulation CE 440/2008 reports that: "If there is evidence that the test substance, or a reactive metabolite, will not reach the target tissue, it is not appropriate to use this test". In light of above issue, no in vivo test was performed.
- Executive summary:
The uncertainties, which are arisen from the in vitro test results, would make desirable a verification by means of an in vivo test, as it is foreseen by the Regulation EC 1907/2006. However, toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance, making non reliable the validated in vivo mutagenicity tests. Indeed, B.11 (In Vivo Mammalian Bone Marrow Chromosome Aberration Test) and B.12 (In Vivo Mammalian Erythrocyte Micronucleus Test) sections of the Regulation CE 440/2008 reports that: "If there is evidence that the test substance, or a reactive metabolite, will not reach the target tissue, it is not appropriate to use this test". In light of above issue, no in vivo test was performed.
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.
