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EC number: 944-710-7 | CAS number: -
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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:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP regulation; full report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate
- EC Number:
- 944-710-7
- Molecular formula:
- not available because multi-constituent substance
- IUPAC Name:
- pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: 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:
- rat Liver S-9
- Test concentrations with justification for top dose:
- 0 - 312,5 - 625 - 1250 - 2500 - 5000 µg/plate
- Vehicle / solvent:
- water
Controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-anthramine (2AM)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 60 min.
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; - Evaluation criteria:
- Treatment of results
In each experiment, for each strain and for each experimental point, the number of revertants per plate was scored. The individual results and the mean number of revertants, with the corresponding standard deviation and ratio (mutants obtained in the presence of the test substance/mutants obtained in the presence of the vehicle), are presented in a table.
Acceptance criteria
This study would be considered valid since the following criteria are fully met:
- the number of revertants in the vehicle controls is consistent with the range of our historical data (appendix 2),
- the number of revertants in the positive controls is higher than that of the vehicle controls and is consistent with the range of our historical data.
Evaluation criteria
A reproducible two-fold increase in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: 100g/L
- Precipitation: No
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No relevant toxicity was noted towards all the strains used, both with and without S9 mix. - Remarks on result:
- other: strain/cell type: TA 100
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
First experiment with S9
Strain |
Dose (µg/plate) |
Revertants / Plate (Mean) |
Standard eviation |
Ratio |
TA 100 |
0 |
95 |
16 |
1,00 |
|
312,5 |
92 |
5 |
0,97 |
|
625 |
111 |
11 |
1,17 |
|
1250 |
112 |
8 |
1,18 |
|
2500 |
105 |
9 |
1,11 |
|
5000 |
101 |
22 |
1,07 |
|
2AM |
2286 |
94 |
24,06 |
|
|
|
|
|
TA102 |
0 |
343 |
33 |
1,00 |
|
312,5 |
352 |
13 |
1,03 |
|
625 |
351 |
19 |
1,02 |
|
1250 |
348 |
8 |
1,02 |
|
2500 |
359 |
25 |
1,05 |
|
5000 |
338 |
35 |
0,99 |
|
2AM |
2139 |
443 |
6,24 |
|
|
|
|
|
TA 98 |
0 |
39 |
8 |
1,00 |
|
312,5 |
47 |
2 |
1,21 |
|
625 |
45 |
2 |
1,15 |
|
1250 |
39 |
4 |
0,99 |
|
2500 |
46 |
5 |
1,17 |
|
5000 |
54 |
3 |
1,39 |
|
2AM |
737 |
57 |
18,9 |
|
|
|
|
|
TA 1535 |
0 |
18 |
6 |
1,00 |
|
312,5 |
21 |
5 |
1,21 |
|
625 |
26 |
2 |
1,45 |
|
1250 |
28 |
10 |
1,58 |
|
2500 |
19 |
3 |
1,06 |
|
5000 |
19 |
7 |
1,09 |
|
2AM |
278 |
65 |
15,72 |
|
|
|
|
|
TA 1537 |
0 |
19 |
8 |
1,00 |
|
312,5 |
24 |
4 |
1,26 |
|
625 |
19 |
5 |
0,98 |
|
1250 |
15 |
5 |
0,79 |
|
2500 |
24 |
5 |
1,22 |
|
5000 |
21 |
5 |
1,07 |
|
2AM |
95 |
11 |
4,90 |
Second experiment with S9
Strain |
Dose (µg/plate) |
Revertants / Plate (Mean) |
Standard Deviation |
Ratio |
TA 100 |
0 |
94 |
10 |
1,00 |
|
312,5 |
144 |
9 |
1,54 |
|
625 |
178 |
24 |
1,90 |
|
1250 |
200 |
15 |
2,13 |
|
2500 |
271 |
32 |
2,90 |
|
5000 |
168 |
4 |
1,79 |
|
2AM |
1153 |
32 |
12,31 |
|
|
|
|
|
TA102 |
0 |
365 |
27 |
1,00 |
|
312,5 |
423 |
19 |
1,16 |
|
625 |
403 |
5 |
1,10 |
|
1250 |
403 |
16 |
1,10 |
|
2500 |
397 |
9 |
1,09 |
|
5000 |
374 |
10 |
1,02 |
|
2AM |
2670 |
123 |
7,31 |
|
|
|
|
|
TA 98 |
0 |
39 |
4 |
1,00 |
|
312,5 |
49 |
8 |
1,26 |
|
625 |
54 |
6 |
1,38 |
|
1250 |
57 |
5 |
1,45 |
|
2500 |
56 |
9 |
1,44 |
|
5000 |
44 |
13 |
1,13 |
|
2AM |
1098 |
240 |
28,16 |
|
|
|
|
|
TA 1535 |
0 |
20 |
4 |
1,00 |
|
500 |
20 |
3 |
0,98 |
|
1000 |
19 |
5 |
0,95 |
|
2000 |
17 |
1 |
0,85 |
|
2500 |
21 |
3 |
1,02 |
|
5000 |
18 |
2 |
0,90 |
|
2AM |
214 |
9 |
10,54 |
|
|
|
|
|
TA 1537 |
0 |
16 |
2 |
1,00 |
|
312,5 |
17 |
3 |
1,02 |
|
625 |
20 |
8 |
1,24 |
|
1250 |
16 |
1 |
1,00 |
|
2500 |
14 |
6 |
0,86 |
|
5000 |
10 |
2 |
0,63 |
|
2AM |
82 |
15 |
5,02 |
Third Experiment with S9
Strain |
Dose (µg/plate) |
Revertants / Plate (Mean) |
Standard Deviation |
Ratio |
TA 100 |
0 |
146 |
8 |
1,00 |
|
625 |
244 |
7 |
1,67 |
|
1250 |
305 |
11 |
2,09 |
|
2500 |
341 |
6 |
2,34 |
|
3000 |
341 |
32 |
2,34 |
|
5000 |
309 |
46 |
2,12 |
|
2AM |
1117 |
144 |
7,65 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation only in strain TA 100 after preincubation
The test item showed mutagenic activity in a bacterial reverse mutation test on Salmonella typhimuriumTA 100 strain, with metabolic activation and preincubation method. - Executive summary:
The objective of this study was to evaluate the potential of the test substance to induce reverse mutation in Salmonella typhimurium.
The test item was tested in two independent experiments, with or without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254.
A third experiment was performed with S9 mix.
The first experiment was performed according to the direct plate incorporation method. The second and the third with S9 mix were performed according to the preincubation method (60 minutes, 37C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used.
Each strain was exposed to five dose-levels of the test substance (three plates/dose-level).
After 48 to 72 hours of incubation at 37C, the revertant colonies were scored.
The test substance was dissolved in distilled water.
Results
The test substance was freely soluble in the vehicle at 54.348 mg/ml, corresponding to 50 mg of the active material/ml (purity of the commercial product: 92%). Since the test substance was freely soluble and non-toxic in the preliminary toxicity test, the highest dose-level was 5000 µg/plate, according to the criteria specified in the guidelines.
The selected treatment-levels for the mutagenicity experiments were: 312.5, 625, 1250, 2500 and 5000 µg/plate, for all strains in the first and second experiments, except for the TA 1535 strain in the second experiment with S9 mix where the treatment-levels were: 500, 1000,2000,2500 and 5000 µg/plate.
In the third experiment, the dose-levels were: 625, 1250, 2500, 3000 and 5000 µg/plate.
Slight to strong blue coloration was observed in the Petri plates when scoring the revertants at dose-levels. This coloration did not impede the automatic counting of the bacterial colonies. No precipitate was observed at any dose-level.
No relevant toxicity was noted towards all the strains used, both with and without S9 mix.
The test substance did not induce any significant increase in the number of revertants, with S9 mix and without S9 mix, in any of the five strains using the direct plate incorporation method.
With S9 mix and the preincubation method, a significant increase in the number of revertants, in comparison to the vehicle control, was noted in the TA 100 strain, at the dose-levels of 1250 and 2500 µg/plate. In addition, a dose-related increase was observed in this strain, at all dose-levels tested, except at the highest dose-level of 5000 µg/plate where a slight toxicity could have masked the increase in the number of revertants.
A third experiment was performed under the same conditions, in order to check the reproducibility of the significant increase observed. In this third experiment, the significant induction of the number of revertants was confirmed.
The number of revertants of the vehicle and positive controls was as specified in the acceptance criteria.
The study was therefore considered as valid.
Conclusion
Under our experimental conditions, the test substance showed mutagenic activity in this bacterial reverse mutation test on Salmonella typhimuriumTA 100 strain, with metabolic activation and preincubation method.
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