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Toxicological information

Developmental toxicity / teratogenicity

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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:
2012
Bibliographic source:
Shepard's

Materials and methods

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

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
Test material form:
not specified
Details on test material:
no data

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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