Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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: EC B.14 / Ames-Test
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium LT 2 TA 98, TA 100, TA 1535, TA 1537
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 8 ... 5000 µg/plate
Concentration range in the main test {without metabolic activation}: 8 ... 5000 µg/plaie

Results and discussion

Test resultsopen allclose all
Species / strain:
other: Salmonella typhimurium LT 2 TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
32 µg/plate
Species / strain:
other: Salmonella typhimurium LT 2 TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
1000 µg/plate
Species / strain:
other: Salmonella typhimurium LT 2 TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
40 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 substance was non mutagenic under the conditions of the test