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Toxicological information

Genetic toxicity: in vitro

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Administrative data

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD method, GLP compliance

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Reverse mutation assay (Ames test + E. Coli). OECD Guideline n° 471 (1983) EEC Directive 84/449 (1984) - Annex V - Method B14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: Salmonella Typhimurium TA98 - TA100 - TA1535 - TA1537 -TA1538 Escherichia coli tryptophan auxotroph WP2uvrA
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Concentration range in the main test (wifh metabolic activation): 100 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 μg/plate
Vehicle:
Solvent: Dimethylsulfoxide (DMSO)
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 1000 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation