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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

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
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Species / strain
Species / strain:
other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538 Escherichia coli tryptophan auxotroph WP2uvrA
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation ): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation ): 100 ... 5000 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
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:
not specified
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:
not specified
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:
not specified
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

The test substance was found to be non-mutagenic under the condition of the test.