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Toxicological information

Carcinogenicity

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Description of key information

No evidence of carcinogenicity was found in rats or mice in doses up to 100 and 1000 mg/kg bw day.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
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:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: gavage
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:
up to 104 weeks
Frequency of treatment:
no data
Post exposure period:
no data
Remarks:
Doses / Concentrations:
up to 1000 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
no data
Details on study design:
no data
Positive control:
no data
Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data
Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
no data
Relevance of carcinogenic effects / potential:
No evidence of carcinogenicity in rats

The dose represents approximately more than 70 times the maximum recommended human daily dose (of 32 mg).

Conclusions:
No evidence of carcinogenicity was found when candesartan cilexetil was given to rats (via gavage)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Species:
rat

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No evidence of carcinogenicity was found when candesartan cilexetil was given to mice or rats. Moreover, no evidence of increased carcinogenicity due to angiotensin II antagonists has been found.

Considering the results of these observations, and according to CLP Regulation the substance was not classified for the class carcinogenicity.

Additional information

No evidence of carcinogenicity was found when candesartan cilexetil was given to mice (via diet) or rats (via gavage) for up to 104 weeks in doses of up to 100 and 1000 mg/kg of body weight per day, respectively. These doses represent approximately 7 and

more than 70 times the maximum recommended human daily dose of 32 mg, respectively

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