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:
August-December 2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Target gene:
amino acid histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
156.25, 312.5, 625, 1250, 2500 and 5000 µg/plate
Controls
Untreated negative controls:
yes
Remarks:
dimethyl sulfoxide
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
other: 2-aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Reduction in number of revertant colonies was not observed in both presence and absence of metabolic activation in all tester strains up to the tested concentration of 5000 µg/plate.

No increase in the number of revertant colonies was observed both in the absence and presence of the metabolic activation system (10% v/v S9 mix) in all the tester strains.

Results revealed that there was no positive mutagenic effect in tester strains TA1537, TA1535, TA98, TA100 and TA102 at the tested concentrations of 156.25, 312.5, 625, 1250, 2500 and 5000 µg/plate of substance in the absence and presence of metabolic activation system (10% v/v S9 mix), when compared with the concurrent negative control.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

From the results of the study, it is concluded that the substance is non-mutagenic to any of the five strains of Salmonella typhimurium viz. TA1537, TA1535, TA98, TA100 and TA102.
Executive summary:

The study was performed to evaluate mutagenic actvity of the substance by the bacterial reverse mutation test, using five histidine mutant tester strains of Salmonella typhimutium (i.e. TA1537, TA1535, TA98, TA100 and TA102).

The substance did not induce any significant increase in the number of revertants, in both trials, with and without S9 mix, in any of the five tester strains. All the values for the negative control were within historical control ranges of the laboratory and positive controls showed an increase in the number of revertant colonies, demonstrating the efficiency of the test system. All criteria for a valid study were met.

From the results of this study, under the specified experimental conditions, the tested substance is concluded to be non-mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium.