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
Study period:
17.6.1993 - 16.7.1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no E. coli or equivalent Salmonella strain tested
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538
Metabolic activation:
with and without
Metabolic activation system:
liver microsomal fraction (S9)
Test concentrations with justification for top dose:
First experiment: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
Second experiment: 312.5, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation
Vehicle / solvent:
- Vehicle/solvent used: dimethyl sulphoxide (DMSO)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with S9: N-Ethyl-N'-nitro-N-nitrosoguanidine (TA100 and TA1535), 9-Aminoacridine (TA1537), 4-Nitro-o-phenylenediamine (TA1538), 4-Nitroquinoline-1-oxide (TA98); without S9: 2-Aminoanthracene (TA1535), Benzo(a)pyrene (all other strains)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: Three replications each in two independent assays.

DETERMINATION OF CYTOTOXICITY
- Method: observation of background lawn

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was observed up to doses of 5000 µg/plate in any of the tester strains.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance caused no reduction in the growth of the bacterial lawn at any of the dose levels employed in any of the strains of Salmonella tested. The test substance was, therefore, tested up to the maximum recommended dose of 5000 µg/plate.

No significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose either with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

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