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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.