1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

Carcinogenicity

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