Registration Dossier

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: Study performed according to guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
1st test: 8, 40, 200, 1000, 5000 microg/plate
2nd test: without S9: TA 100, 1535, 1537 and 98: 12.5, 25, 50, 100, 200 microg/plate
TA 1538: 6.25, 12.5, 25, 50, 100 microg/plate
2nd test: with S9: TA 100, 1535, 1537 and 98: 62.5, 125, 250, 500, 1000 microg/plate
TA 1538: 12.5, 25, 50, 100, 200 microg/plate
Vehicle / solvent:
Ethanol
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
other: 4-nitro-phenylendiamine
Details on test system and experimental conditions:
according to guideline
Evaluation criteria:
according to guideline
Statistics:
according to guideline

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test item did not show any indication for genotoxic toxicity in this assay.