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EC number: 219-228-9 | CAS number: 2390-54-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[4-(dimethylamino)phenyl]-3,6-dimethylbenzothiazolium chloride
- EC Number:
- 219-228-9
- EC Name:
- 2-[4-(dimethylamino)phenyl]-3,6-dimethylbenzothiazolium chloride
- Cas Number:
- 2390-54-7
- Molecular formula:
- C17H19N2S.Cl
- IUPAC Name:
- 2-[4-(dimethylamino)phenyl]-3,6-dimethylbenzothiazolium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
Method
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:
- The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 1000 μg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades. Two independent experiments were performed with the following concentrations:
Experiment I:
3.16, 10.0, 31.6, 100, 316 and 1000 μg/plate in addition: 1.00 μg/plate for TA 1535, TA 1537 and TA 102
Experiment II:
1.58, 5.0, 15.8, 50, 158 and 500 μg/plate
As the results of the pre-experiment were in accordance with the criteria described above, these were reported as a part of the main experiment I. - Vehicle / solvent:
- The test item was suspended in ethanol, processed by ultrasound for 5 min at 37 °C and diluted
prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest., Eurofins Munich, Lot No. 170220)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol, AppliChem Lot No. 5Y013701
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine; 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test item was observed in all tester strains used in experiment I (with and
without metabolic activation) at a concentration of 1000 μg/plate.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Basic Yellow 1 did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Basic Yellow 1 is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
In order to investigate the potential of Basic Yellow 1 for its ability to induce gene mutations the plate incorporation test (experiment I and II) was performed with the Salmonella typhimurium strains
TA 98, TA 100, TA 1535, TA 1537 and TA 102.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments:
Experiment I:
3.16, 10.0, 31.6, 100, 316 and 1000 μg/plate in addition: 1.00 μg/plate for TA 1535, TA 1537 and TA 102
Experiment II:
1.58, 5.0, 15.8, 50, 158 and 500 μg/plate
Precipitation was observed in all tester strains used in experiment I (with and without metabolic activation).
Toxic effects of the test item were noted in all tester strains used in experiment I and II:
- In experiment I toxic effects of the test item were observed at concentrations of 316 μg/plate and higher (with and without metabolic activation) depending on the particular tester strain.
- In experiment II toxic effects of the test item were noted at a concentration of 500 μg/plate (with and without metabolic activation) in all tester strains tested.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Basic Yellow 1 at any concentration level, neither in the presence
nor absence of metabolic activation in experiment I and II.
All criteria of validity were met.
Conclusion
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Basic Yellow 1 did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Basic Yellow 1 is considered to be non-mutagenic in this bacterial reverse mutation assay.
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