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
Genetic toxicity in vivo
Description of key information
Link to relevant study records
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: mouse micronucleus
- 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.
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- other: no data
- Vehicle:
- no data
- Details on exposure:
- no data
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- no data
- Post exposure period:
- no data
- Remarks:
- Doses / Concentrations:
Basis:
no data - No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Positive control(s):
- no data
- Tissues and cell types examined:
- no data
- Details of tissue and slide preparation:
- no data
- Evaluation criteria:
- no data
- Statistics:
- no data
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- no data
- Conclusions:
- Interpretation of results: negative
Candesartan was evaluated in vivo in the mouse micronucleus test with negative results. - Executive summary:
Candesartan was evaluated in vivo in the mouse micronucleus test with negative results.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Candesartan was evaluated in vivo e in vitro tests (Chinese hamster lung (CHL) chromosomal aberration assay, Ames Test, mouse lymphoma cell assay and Chinese hamster ovary (CHO) gene mutation assay): in every case, the result was Negative.
Justification for selection of genetic toxicity endpoint
In vivo investigation
Justification for classification or non-classification
Considering the results obtained from in vitro e in vivo tests, according to CLP Regulation the substance was not classified for the class Germ cell mutation.
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