Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
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
no data
Reproductive effects observed:
not specified

candesartan did not impair fertility in male or female rats

Conclusions:
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

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