Registration Dossier
Registration Dossier
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EC number: 604-138-8 | CAS number: 139481-59-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- not specified
- 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:
- 2 013
- Bibliographic source:
- HSDB
Materials and methods
- Objective of study:
- distribution
- 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
- Radiolabelling:
- not specified
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
- Vehicle:
- not specified
- Details on exposure:
- no data
- Duration and frequency of treatment / exposure:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
no data
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- not specified
- Positive control reference chemical:
- no data
- Details on study design:
- no data
- Details on dosing and sampling:
- no data
- Statistics:
- no data
Results and discussion
- Preliminary studies:
- no data
Main ADME results
- Type:
- distribution
- Results:
- 0.13 L/kg
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no data
- Details on distribution in tissues:
- distribution across the blood-brain barrier is poor
- Details on excretion:
- no data
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- no data
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- no data
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: other: Volume of distribution - 0.13 L/kg
Volume of distribution - 0.13 L/kg.
Candesartan does not penetrate red blood cells
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