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Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptale restrictions
Qualifier:
according to
Guideline:
other: Annex V (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
bacteria, other: Salmonella lyphimurium: TA98,TA100,TA1535,TA1537E,Coil:WP2uvrA
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test(with metabolic activation):312.5...5000 ug/plate
Concentration range in the main test(without metabolic activation):312.5...5000 ug/plate
Vehicle / solvent:
Dimethylsulfoxide
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 313 ug/plate
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 ug/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000 ug/plate
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>500 ug/plate
Additional information on results:
Observations:
There are no sgnificant increases in the numbers of revertant colonies as a result of exposure to the test substance.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification