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EC number: 216-612-8 | CAS number: 1624-02-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2009-11-16 - 2010-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- For the distribution of the top agar on the minimal-glucose-plates, the plates were slowly shaken instead of using the Drigalski-spatula. As distribution was good, this was considered as uncritical.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Due to a calculation error, cultivation of strain TA 102 was performed using 2 mg/L tetracycline instead of 20 mg/L. As genotype confirmation and spontaneous rever¬tants were normal, this was considered as uncritical.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- For the second and the third experiment, the concentration of the stock solution was 20 g/L. For the fourth experiment, the concentration of the stock solution was 5 g/L.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(triphenylsilyl) chromate
- EC Number:
- 216-612-8
- EC Name:
- Bis(triphenylsilyl) chromate
- Cas Number:
- 1624-02-8
- Molecular formula:
- C36H30CrO4Si2
- IUPAC Name:
- 3,3-dioxo-1,1,1,5,5,5-hexaphenyl-2,4-dioxa-1,5-disila-3-chromapentane
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- First experiment: 4999 /1500 / 500 /150 / 50 μg/plate
Second experiment: 150/50/15/5/1.5 μg/plate
Third experiment: 150/75/38/19/ 10/5/2.5 μg/plate
Fourt experiment: 1.25 / 0.625 / 0.312 / 0.156 / 0.08 / 0.04 μg/plate - Vehicle / solvent:
- Tetrahydrofurane (THF)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
The test item is considered not mutagenic. - Executive summary:
Mutagenicity of Test Item
The test item did not show mutagenic effects in all four experiments. The number of rever- tant colonies was not increased in comparison with the spontaneous revertants (solvent only).
Cytotoxicity of the test item was detected in the first experiment in the upper three concentrations: 5000 pg/plate, 1500 [jg/plate and 500 pg/plate and in the third experiment in all seven concentrations (150 - 2.5 pg/plate).
Therefore it can be stated, that under the test conditions, the test item Bis(triphenylsilyl)- chromate is not mutagenic in the Bacterial Reverse Mutation Test usingSalmonella typhi- murium,strains TA 97a, TA 98, TA 100, TA 102 and TA 1535 in concentrations below the toxicity threshold.
Acceptability of Study
Most spontaneous revertants and positive control values were within the range of the historical data; if they lay outside the range, the differences to the respective maximum or minimum of the history were marginal only. Mutagenicity of the positive controls was detected without doubts. Therefore, the result of the test is considered valid.
Discussion
The test item is considered not mutagenic for the reasons given above.
No sings of toxicity could be observed in the toxicity control. Therefore, the highest concentration was 5000 Mg/plate for the first experiment.
But the test item showed cytotoxicity towards the bacteria in the first experiment in the upper three concentrations, therefore a second experiment was performed with five concentrations and again using the plate-incorporation-method. The maximum dose in the second experiment was 150 fjg/plate. No toxicity and no mutagenicity were detected.
On the base of the results of the second experiment, a third experiment was performed with seven concentrations using the pre-incubation-method. The test item showed cytotoxicity in all seven concentrations. Therefore, a fourth experiment was performed with six lower concentrations.
The confirmation tests of the genotype did not show any irregularities. The control of the titre was above the demanded value. The revertant colonies of the positive controls were in the range of the historical data of the laboratory (see page 49) and were definitely increased in comparison with the negative controls, as well as showing mutagenous potential of the diagnostic mutagenes.
Spontaneous revertants were within the normal range in comparison with the historical data of the LAUS GmbH.
For these reasons, the result of the test is considered valid.
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