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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to Japanese guidelines

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to 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:
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Test material form:
other: liquid


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
Negative solvent / vehicle controls:
distilled water
Positive controls:
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.
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
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
Positive controls validity:
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
Migrated from field 'Test system'.

Applicant's summary and conclusion

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.