Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction: other studies
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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
No information
Bibliographic source:
Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 692

Materials and methods

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

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:
rat
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
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Duration of test:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data

Results and discussion

Applicant's summary and conclusion

Conclusions:
Candesartan is distributed into the milk of lactating rats. It is not known whether candesartan is distributed into human breast milk.