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Key value for chemical safety assessment

Genetic toxicity in vivo

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay
Species:
mouse
Sex:
male
Remarks:
Doses / Concentrations:
300, 600, 800
Basis:
no data
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Conclusions:
Interpretation of results (migrated information): negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

Mutagenic potential was studied by in vitro or in vivo tests. The results of the in vitro studies did not suggest the risk of gene mutation while chromosomal aberrations had been observed, mainly without metabolic activation. Nevertheless, such effects were not confirmed by repeating the test or by in vivo studies.


Justification for selection of genetic toxicity endpoint
In vivo study

Justification for classification or non-classification

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