Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vivo

Description of key information
Candesartan was evaluated in vivo in the mouse micronucleus test (and in others in vitro test) with a Negative result.
Link to relevant study records
Reference
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

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.

Categories Display