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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
Reference substance name:
2-ethoxy-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylic acid
EC Number:
604-138-8
Cas Number:
139481-59-7
Molecular formula:
C24H20N6O3
IUPAC Name:
2-ethoxy-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylic acid
Constituent 2
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

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