Registration Dossier
Registration Dossier
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EC number: 604-138-8 | CAS number: 139481-59-7
Toxicity to reproduction: other studies
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
- 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
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
