Registration Dossier
Registration Dossier
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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.
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