Registration Dossier
Registration Dossier
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EC number: 270-821-9 | CAS number: 68478-46-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- study proposal for Comet Assay
- Type of information:
- experimental study planned
- Justification for type of information:
- For the test item three in vitro tests were performed from 2017 to 2020. The Ames test according to OECD 471 and the micronucleus test according to OECD 487 have a negative outcome for genotoxicity. However, the HPRT test, which was performed 2018 at LPT showed clear positive genotoxic effects in the absence of metabolic activation. According to the REACH regulation Annex VIII an in vivo genotoxicity study has to be performed if at least one in vitro genotoxicity test showes a positive outcome.
Based on these data, we recommend to perform the combined in vivo mammalian erythrocyte micronucleus test according to OECD 474) and the in vivo mammalian alkaline Comet assay according to OECD 489 (in the liver and the stomach) as the most suitable in vivo genotoxicity tests for the test item.
Literature search showed no other available GLP and or no GLP studies for this endpoint nor any historical human data for the substance. As there are no other similar substances available grouping and read across can not be performed. As the substance is an UVCB substance application of QSAR tools/methods is not applicable.
Other in vitro methods are not relevant as all three endpoints (gene mutation, chromosome aberration, and micronucleus test) are already covered and an in vivo test is necessary after one positive in vitro test according to REACH regulation Annex VIII: According to REACH regulation Annex VIII ….”an in vivo method should be performed if there is one or more positive in vitro test in annex VII or VIII”.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Test material
- Reference substance name:
- Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether
- EC Number:
- 270-821-9
- EC Name:
- Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether
- Cas Number:
- 68478-46-6
- Molecular formula:
- C14H23BF3NO2
- IUPAC Name:
- 1-phenylmethanamine; 7-[(benzylamino)methyl]-10-(butoxymethyl)-5,8,11,15-tetraoxaicosan-13-ol; benzyl(3-butoxy-2-hydroxypropyl)amine; benzyl[3-butoxy-2-(3-butoxy-2-hydroxypropoxy)propyl]amine; dibenzyl(3-butoxy-2-hydroxypropyl)amine
- Test material form:
- liquid: viscous
- Details on test material:
- Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether, Batch: NC18201915
Constituent 1
Results and discussion
Applicant's summary and conclusion
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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