Registration Dossier
Registration Dossier
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EC number: 604-138-8 | CAS number: 139481-59-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- fertility, other
- Remarks:
- based on test type
- Type of information:
- experimental study
- Adequacy of study:
- other information
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on exposure:
- no data
- Details on mating procedure:
- 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
- Details on study schedule:
- no data
- Remarks:
- Doses / Concentrations:
300 mg/kg/day
Basis:
no data - No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
- Parental animals: Observations and examinations:
- no data
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- no data
- Postmortem examinations (parental animals):
- no data
- Postmortem examinations (offspring):
- no data
- Statistics:
- no data
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- Candesartan did not impair fertility in male or female rats.
Reference
candesartan did not impair fertility in male or female rats
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
In human: Oliguria, perinatal renal failure, neonatal kidney dysfunction, developmental delay, and death associated with use of candesartan during the 2nd and 3rd trimester.
Rats do not represent a good model to study the potency of action of this substance to cause developmental impariment in pupies.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
Justification for classification or non-classification
Considering the available results and according to CLP Regulation, the substance was classified as Repro 2 H361d (specifi effect: oligohydramniosi).
Additional information
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.
