Registration Dossier
Registration Dossier
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: 604-138-8 | CAS number: 139481-59-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A reliable secondary source, summarising Candesartan properties, was used. However the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used; it covers the most updated literature on the substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- No information
- Bibliographic source:
- Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 691
Materials and methods
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2-ethoxy-1-{[2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1H-1,3-benzodiazole-7-carboxylic acid
- EC Number:
- 604-138-8
- Cas Number:
- 139481-59-7
- Molecular formula:
- C24H20N6O3
- IUPAC Name:
- 2-ethoxy-1-{[2'-(1H-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1H-1,3-benzodiazole-7-carboxylic acid
- Reference substance name:
- O-deethyl metabolite of Candesartan
- IUPAC Name:
- O-deethyl metabolite of Candesartan
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Constituent 2
Method
- Target gene:
- chinese hamster lung
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- no data
- Vehicle / solvent:
- no data
- Details on test system and experimental conditions:
- no data
- Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- not specified
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: other: no data
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Candesartan and its O-deethyl metabolite tested positive for genotoxicity in the in vitro chinese hamster lung (CHL) chromosomal aberration assay
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive
Candesartan and its O-deethyl metabolite tested positive for genotoxicity in the in vitro chinese hamster lung (CHL) chromosomal aberration assay
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.
