Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: mouse micronucleus
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

Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
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
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
other: no data
Vehicle:
no data
Details on exposure:
no data
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Positive control(s):
no data

Examinations

Tissues and cell types examined:
no data
Details of tissue and slide preparation:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
no data

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Candesartan was evaluated in vivo in the mouse micronucleus test with negative results.
Executive summary:

Candesartan was evaluated in vivo in the mouse micronucleus test with negative results.