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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to Japanese guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Procedures of Mutagenicity Test Using Microorganisms and Evaluation of Test Results" (1999), "Reverse Mutagenicity Test on Bacteria" of "Mutagenicity Test" stipulated in the "Testing Methods for New Chemical Substances" (2011)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Test material form:
other: liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
Vehicle / solvent:
distilled water
Controls
Negative solvent / vehicle controls:
yes
Remarks:
distilled water
Positive controls:
yes
Positive control substance:
sodium azide
other: 2-Aminoanthracene, 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide, ICR-191
Details on test system and experimental conditions:
This study was performed by the pre-incubation method without and with S9 mix.
Triplicate plates were used for the negative control group, and duplicate plates were used for the positive control and the test substance treatment groups.
Evaluation criteria:
The test substance was judged to be positive when the number of revertant colonies increased to twice or more that in the negative control and when the responses were dose-related and/or reproducible. The other cases were judged to be negative.
Statistics:
No statistical methods were used.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The number of revertant colonies in the test substance treatment groups was less than twice that in each negative control for all tester strains without and with S9 mix. The bacterial growth inhibition was not observed at any test condition. The precipitation of the test substance was not observed in the absence and presence of S9 mix.
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 without metabolic activation
negative with metabolic activation

It was concluded that the substance had no ability to induce mutations under the present test conditions.

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