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EC number: 700-222-4 | CAS number: 1065519-44-9
Toxicological information
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
- EC Number:
- 700-222-4
- Cas Number:
- 1065519-44-9
- Molecular formula:
- C22H28N6O7S
- IUPAC Name:
- N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
- Reference substance name:
- No. 408 Yellow
- IUPAC Name:
- No. 408 Yellow
- Details on test material:
- - Name of test material (as cited in study report): No. 408 Yellow
- Physical state: yellow powder
- Analytical purity: 98.6%
- Purity test date: 07 November 2008
- Lot/batch No.: 081105-1
- Expiration date of the lot/batch: 04 November 2009
- Stability under test conditions:
- Storage condition of test material: room temperature, dark, sealed container
- Other: Source: TOYO INK MFG. CO. LTD.; pH of 33% w/v dispersion was 9.3
Constituent 1
Constituent 2
Method
- Target gene:
- His-operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Range-finder (TA100 ± S9) and Experiment 1 (all strains ± S9): 1.6, 8, 40, 200, 1000, 5000 μg/plate;
Experiment 2: (TA98, 1535 ± S9; TA102 + S9) 39.0625, 78.125, 156.25, 312.5, 625, 1250, 2500, 5000; (TA100, 1537 ± S9; TA102 - S9) 156.25, 312.5, 625, 1250, 2500, 3500, 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: suspension in 0.5% methylcellulose (MC)
- Justification for choice of solvent/vehicle: test substance was insoluble in the solvents most commonly used
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, 1535 without S9
Migrated to IUCLID6: 2 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 5 μg/plate
- Remarks:
- TA100, 1535, 1537 with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without S9
Migrated to IUCLID6: 5 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA98 with S9
Migrated to IUCLID6: 10 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S9
Migrated to IUCLID6: 50 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- TA102 without S9
Migrated to IUCLID6: 0.2 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.5% methylcellulose
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 20 μg/plate
- Remarks:
- TA102 with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: not applicable
- Exposure duration: 3 days
SELECTION AGENT (mutation assays): his-deficiency
NUMBER OF REPLICATIONS: triplicates, vehicle controls in quintuplicates
DETERMINATION OF CYTOTOXICITY
- Method: other: reduction of background lawn - Evaluation criteria:
- The assay was considered valid if the following criteria were met:
1. the negative control counts fell within the historical ranges.
2. the positive control chemicals induced clear increases in revertant numbers confirming discrimination between different strains, and an active S-9
preparation
3. no more than 5% of the plates were lost through contamination or some other unforeseen event.
The test article was considered to be mutagenic in this assay if:
1. the assay is valid (see above)
2. Dunnett's test gives a significant response (p ? 0.01) and the data set(s) shows a significant dose correlation - Statistics:
- Individual plate counts from all experiments were recorded separately and the mean and standard deviation of the plate counts for each treatment were determined. Control counts were compared with historical controls. Dunnett's test was used to compare the counts at each concentration with the control. The presence a concentration response was checked by non-statistical analysis, up to limiting levels (for example toxicity, precipitation or 5000 μg/plate).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate + S9 in experiment 1 only; in experiment 2, no cytotoxicity was observed at all, but precipitation occurred at 5000 μg/plate ± S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535, 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at 5000 μg/plate in all experiments
RANGE-FINDING/SCREENING STUDIES:
An initial toxicity Range-Finder Experiment was carried out ± S9 in strain TA100 only, using final test substance concentrations of 1.6, 8, 40, 200, 1000 and 5000 μg/plate, plus negative (vehicle) and positive controls. Following these treatments, no evidence of toxicity was observed. Strain TA100 was included in Experiment 1 to investigate an increase in revertant numbers observed.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean numbers of revertant colonies on negative control plates all fell within acceptable historical ranges, and were significantly elevated by positive control treatments. One experiment in one strain showing variations was repeated.
Any other information on results incl. tables
Overview positive tests:
Strain |
Metabolic activation |
Starting concentration (μg/plate) |
Experiment 1 |
||
TA98 |
- S9 |
? 200 |
|
+ S9 |
? 40 |
TA100 |
± S9 |
? 5000 |
TA1537 |
- S9 |
? 1000 |
|
+ S9 |
? 5000 |
Experiment 2 |
||
TA98 |
- S9 |
all concentrations |
|
+ S9 |
? 312.5 |
TA100 |
- S9 |
? 625 |
|
+ S9 |
? 312.5 |
TA1537 |
± S9 |
all concentrations |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
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