Registration Dossier
Registration Dossier
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EC number: 604-138-8 | CAS number: 139481-59-7
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- secondary source
- Title:
- Candesartan
- Year:
- 2 012
- Bibliographic source:
- Shepard's
Materials and methods
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
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
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- 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
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- Rat were exposed during three period: prenatally, during organogenesis and perinatally.
- Frequency of treatment:
- no data
- Duration of test:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
Examinations
- Maternal examinations:
- no data
- Ovaries and uterine content:
- no data
- Fetal examinations:
- Rat: at the highest dose there was some delay in fetal ossification.
- Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data. Remark: observed only in rabbits
Details on maternal toxic effects:
no data
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no data
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Rat received up to 300 mg per kg during three periods: prenatally, during organogenesis and perinatally. At the highest dose there was some delay in fetal ossification.
Applicant's summary and conclusion
- Conclusions:
- Rat received up to 300 mg per kg during three periods: prenatally, during organogenesis and perinatally. At the highest dose there was some delay in fetal ossification.
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