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EC number: 279-365-5 | CAS number: 80010-51-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 16 July 1993 to 04 Oct 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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 OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 279-365-5
- EC Name:
- Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 80010-51-1
- Molecular formula:
- C29H28Cl2N4O7S.Na
- IUPAC Name:
- sodium 1-amino-4-[(3,5-bis{[(chloroacetyl)amino]methyl}-2,4,6-trimethylphenyl)amino]-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test material: Polar blau RLS roh trocken (FAT 21036/C)
Batch No.: 410830.32
Purity: about 90 %
Expiration date: June 1998
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 21036/C
Purity: Approx 90 %
Method
- Target gene:
- Histidine for Salmonella
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells: Histidine-auxotrophic strains of Salmonella typhimurium (TA 98, TA 102, TA 1535 and TA 1537) were obtained from Prof. B.
Ames, Berkeley, CA., U.S.A
Strain TA 100 was obtained from Dr. M.Schiipbach, Hofmann-La Roche Ltd., Basle, Switzerland. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat-liver post mitochondrial supernatant (S9 fraction): Rat-liver microsomal fraction S9 was prepared in advance from male RAI rats (Tif: RAIf[SPF]), reared at the Animal Farm of CIBA GEIGY, Sisseln, Switzerland. The animals (150-250 g) were treated with Aroclor 1254 (500 mg/kg, i.p.) 5 days prior to sacrifice. The livers were homogenized with 3 volumes of 150 mM KCl and the 9000x g supernatant (S9) was stored at approximately -80 °C for no longer than one year. The protein contents of the S9 fractions were 33.6 and 30.2 mg/ml.
- Test concentrations with justification for top dose:
- Range in the cytotoxicity test; 20.6, 61.7, 185.1, 555.5, 1666.6, 5000 µg/plate
Range in the mutagenicity test: 61.7, 185.1, 555.5, 1666.6, 5000 µg/plate - Vehicle / solvent:
- Bidistilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- For TA 100 & TA 1535 without microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- For TA 102 without microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- For TA 98 without microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- For TA 1537 without microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2- aminoanthracene
- Remarks:
- For TA 100, TA 102, TA 98& TA 1537 with microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- For TA 1535 with microsomal activation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: Triplicate
- Number of independent experiments : Two
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium: in agar (plate incorporation)
METHODS FOR MEASUREMENT OF CYTOTOXICITY : Background growth inhibition
METHODS FOR MEASUREMENTS OF GENOTOXICIY : Colonies were counted electronically with an Artek counter - Evaluation criteria:
- Assay acceptance criteria:
A test is considered acceptable if the mean colony counts of the control values of all strains are within the acceptable ranges and if the results of the positive controls meet the criteria for a positive response. In either case the final decision is based on the scientific judgement of the study director.
Criteria for a positive response:
The test substance is considered to be mutagenic in this test system if the following conditions are met:
At least a reproducible meaningful increase of the mean number of revertants per plate above that of the negative control at any concentration for one or more of the following strains: S. typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537. Generally a concentration-related effect should be demonstrable. - Statistics:
- In deviation to the OECD guideline. a statistical analysis was not performed. At present the use of statistical methods concerning this particular test system is not generally recommended. No appropriate statistical method is available.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and 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
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
RANGE-FINDING/SCREENING STUDIES
Six concentrations of Polar blau RLS roh trocken (FAT 21036/C) ranging from 20.6 to 5000 µg/plate were tested with strain S. typhimurium TA 100 to determine the highest concentration to be used in the mutagenicity assay. The experiments were performed with and without microsomal activation. The numbers of revertant colonies was not reduced. Normal back-ground growth was observed at all concentrations. The test material exerted no toxic effect on the growth of the bacteria. From the results obtained, the highest concentration suitable for the mutagenicity test was selected to be 5000 µg/plate without and with activation.
Mutagenicity test, original experiment
In the original experiment carried out without metabolic activation, treatment of strain TA 102 with Polar blau RLS roh trocken (FAT 2103 6/C) led to a marginal increase in the number of backmutants at the concentrations of 1666.7 and 5000 µg/plate. No effects were observed with the other strains. In the experiment with activation performed on strain TA 102, a marginal increase in the number of revertants occurred at the concentration of 555.6 µg/plate only. No effects were observed with the other strains.
Mutagenicity test, confirmatory experiment
In the confirmatory experiment performed without microsomal activation, after treatment with Polar blau RLS roh trocken (FAT 21036/C), no increase in the incidence of histidine-prototrophic mutants was observed in comparison with the negative control. The effect observed in the original experiment on strain TA 102 could not be reproduced. In the experiment with activation performed on strain TA 102, a marginal increase in the number of back-mutants occurred at the concentration of 1666.7 µg/plate only. Again, no effects were observed with the other strains. In the mutagenicity tests without and with metabolic activation, normal back-ground growth was observed. The numbers of revertant colonies was not reduced. The test material exerted no toxic effect on the growth of the bacteria. The various mutagens, promutagens, sterility checks, sensitivity and resistance tests, etc., employed to ensure the test system was acceptable, all produced results within our established limits. There were no known circumstances or occurrences in this study that were considered to have affected the quality or integrity of the data.
SUMMARY OF THE MUTAGENICITY EXPERIMENTS
Original experiments without metabolic activation
Strain | Treatment | Mean counts |
TA 100 | Negative control | 126.3 |
61.7284 µg/plate | 141.3 | |
185.1852 µg/plate | 155.0 | |
555.5556 µg/plate | 143.0 | |
1666.6667 µg/plate | 144.3 | |
5000.0000 µg/plate | 108.7 | |
Positive control | 1320.3 |
Strain | Treatment | Mean counts |
TA 1535 | Negative control | 13.7 |
61.7284 µg/plate | 14.7 | |
185.1852 µg/plate | 11.7 | |
555.5556 µg/plate | 11.7 | |
1666.6667 µg/plate | 14.7 | |
5000.0000 µg/plate | 11.33 | |
Positive control | 1100.7 |
Strain | Treatment | Mean counts |
TA 98 | Negative control | 15.0 |
61.7284 µg/plate | 16.0 | |
185.1852 µg/plate | 15.3 | |
555.5556 µg/plate | 21.0 | |
1666.6667 µg/plate | 14.7 | |
5000.0000 µg/plate | 13.0 | |
Positive control | 1582.7 |
Strain | Treatment | Mean counts |
TA 1537 | Negative control | 9.7 |
61.7284 µg/plate | 8.0 | |
185.1852 µg/plate | 9.0 | |
555.5556 µg/plate | 4.3 | |
1666.6667 µg/plate | 5.0 | |
5000.0000 µg/plate | 5.0 | |
Positive control | 2091.7 |
Strain | Treatment | Mean counts |
TA 102 | Negative control | 237.0 |
61.7284 µg/plate | 240.0 | |
185.1852 µg/plate | 273.3 | |
555.5556 µg/plate | 327.3 | |
1666.6667 µg/plate | 394.3 | |
5000.0000 µg/plate | 378.0 | |
Positive control | 1130.3 |
SUMMARY OF THE MUTAGENICITY EXPERIMENTS
Original experiments with metabolic activation
Strain | Treatment | Mean counts |
TA 100 | Negative control | 135.3 |
61.7284 µg/plate | 130.3 | |
185.1852 µg/plate | 142.7 | |
555.5556 µg/plate | 173.0 | |
1666.6667 µg/plate | 159.3 | |
5000.0000 µg/plate | 144.3 | |
Positive control | 1389.7 |
Strain | Treatment | Mean counts |
TA 1535 | Negative control | 17.0 |
61.7284 µg/plate | 17.7 | |
185.1852 µg/plate | 14.7 | |
555.5556 µg/plate | 15.3 | |
1666.6667 µg/plate | 14.3 | |
5000.0000 µg/plate | 10.7 | |
Positive control | 339.7 |
Strain | Treatment | Mean counts |
TA 98 | Negative control | 34.0 |
61.7284 µg/plate | 33.7 | |
185.1852 µg/plate | 29.3 | |
555.5556 µg/plate | 31.3 | |
1666.6667 µg/plate | 23.3 | |
5000.0000 µg/plate | 23.7 | |
Positive control | 2207.3 |
Strain | Treatment | Mean counts |
TA 1537 | Negative control | 7.3 |
61.7284 µg/plate | 9.0 | |
185.1852 µg/plate | 12.0 | |
555.5556 µg/plate | 11.3 | |
1666.6667 µg/plate | 7.3 | |
5000.0000 µg/plate | 4.0 | |
Positive control | 205.7 |
Strain | Treatment | Mean counts |
TA 102 | Negative control | 244.7 |
61.7284 µg/plate | 348.3 | |
185.1852 µg/plate | 295.3 | |
555.5556 µg/plate | 389.3 | |
1666.6667 µg/plate | 349.0 | |
5000.0000 µg/plate | 354.0 | |
Positive control | 1431.7 |
SUMMARY OF THE MUTAGENICITY EXPERIMENTS
Confirmatory experiments without metabolic activation
Strain | Treatment | Mean counts |
TA 100 | Negative control | 173.3 |
61.7284 µg/plate | 195.7 | |
185.1852 µg/plate | 200.3 | |
555.5556 µg/plate | 174.3 | |
1666.6667 µg/plate | 194.3 | |
5000.0000 µg/plate | 183.3 | |
Positive control | 1345.0 |
Strain | Treatment | Mean counts |
TA 1535 | Negative control | 19.0 |
61.7284 µg/plate | 14.7 | |
185.1852 µg/plate | 20.7 | |
555.5556 µg/plate | 18.0 | |
1666.6667 µg/plate | 15.7 | |
5000.0000 µg/plate | 15.0 | |
Positive control | 1187.7 |
Strain | Treatment | Mean counts |
TA 98 | Negative control | 28.3 |
61.7284 µg/plate | 28.7 | |
185.1852 µg/plate | 24.7 | |
555.5556 µg/plate | 24.7 | |
1666.6667 µg/plate | 27.7 | |
5000.0000 µg/plate | 23.0 | |
Positive control | 1935.0 |
Strain | Treatment | Mean counts |
TA 1537 | Negative control | 10.3 |
61.7284 µg/plate | 12.0 | |
185.1852 µg/plate | 14.7 | |
555.5556 µg/plate | 10.0 | |
1666.6667 µg/plate | 9.7 | |
5000.0000 µg/plate | 6.7 | |
Positive control | 2315.0 |
Strain | Treatment | Mean counts |
TA 102 | Negative control | 336.7 |
61.7284 µg/plate | 340.3 | |
185.1852 µg/plate | 391.7 | |
555.5556 µg/plate | 374.3 | |
1666.6667 µg/plate | 419.3 | |
5000.0000 µg/plate | 357.7 | |
Positive control | 1961.0 |
SUMMARY OF THE MUTAGENICITY EXPERIMENTS
Confirmatory experiments with metabolic activation
Strain | Treatment | Mean counts |
TA 100 | Negative control | 184.7 |
61.7284 µg/plate | 208.3 | |
185.1852 µg/plate | 226.7 | |
555.5556 µg/plate | 219.3 | |
1666.6667 µg/plate | 226.0 | |
5000.0000 µg/plate | 213.7 | |
Positive control | 1881.0 |
Strain | Treatment | Mean counts |
TA 1535 | Negative control | 17.3 |
61.7284 µg/plate | 24.3 | |
185.1852 µg/plate | 20.7 | |
555.5556 µg/plate | 16.3 | |
1666.6667 µg/plate | 25.3 | |
5000.0000 µg/plate | 19.7 | |
Positive control | 378.7 |
Strain | Treatment | Mean counts |
TA 98 | Negative control | 42.7 |
61.7284 µg/plate | 43.0 | |
185.1852 µg/plate | 49.3 | |
555.5556 µg/plate | 47.0 | |
1666.6667 µg/plate | 33.7 | |
5000.0000 µg/plate | 33.7 | |
Positive control | 2659.0 |
Strain | Treatment | Mean counts |
TA 1537 | Negative control | 14.7 |
61.7284 µg/plate | 9.3 | |
185.1852 µg/plate | 12.3 | |
555.5556 µg/plate | 15.3 | |
1666.6667 µg/plate | 9.0 | |
5000.0000 µg/plate | 6.7 | |
Positive control | 414.7 |
Strain | Treatment | Mean counts |
TA 102 | Negative control | 331.7 |
61.7284 µg/plate | 369.3 | |
185.1852 µg/plate | 379.7 | |
555.5556 µg/plate | 427.3 | |
1666.6667 µg/plate | 496.3 | |
5000.0000 µg/plate | 458.7 | |
Positive control | 1723.3 |
Applicant's summary and conclusion
- Conclusions:
- FAT 21036/C was not mutagenic in this bacterial reverse mutation assay.
- Executive summary:
A study was performed to investigate the potential of FAT 21036/C to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. This test was conducted in accordance with OECD test guideline 471. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test article was tested at the following concentrations:
Range in the cytotoxicity test; 20.6, 61.7, 185.1, 555.5, 1666.6, 5000 µg/plate
The concentration range of FAT 21036/C to be tested in the mutagenicity test was determined in a preliminary toxicity test. Thus, the test material was tested for mutagenic effects without and with metabolic activation at five concentrations in the range 61.7, 185.1, 555.5, 1666.6, 5000 µg/plate.
Mutagenicity test, original experiment
In the original experiment carried out without metabolic activation, treatment of strain TA 102 with Polar blau RLS roh trocken (FAT 2103 6/C) led to a marginal increase in the number of backmutants at the concentrations of 1666.7 and 5000 µg/plate. No effects were observed with the other strains. In the experiment with activation performed on strain TA 102, a marginal increase in the number of revertants occurred at the concentration of 555.6 µg/plate only. No effects were observed with the other strains.
Mutagenicity test, confirmatory experiment
In the confirmatory experiment performed without microsomal activation, after treatment with Polar blau RLS roh trocken (FAT 21036/C), no increase in the incidence of histidine-prototrophic mutants was observed in comparison with the negative control. The effect observed in the original experiment on strain TA 102 could not be reproduced. In the experiment with activation performed on strain TA 102, a marginal increase in the number of back-mutants occurred at the concentration of 1666.7 µg/plate only. Again, no effects were observed with the other strains. In the experiment without and with metabolic activation no toxic effect of the test material on the growth of the bacteria was observed. A marginal increase in backmutants was reported with strain TA 102 with metabolic activation at 555.6 µg/plate only in the original experiment and at 1666.7 µg/plate only in the confirmatory experiment. This marginal effect seen was regarded as not significant as the increase was seen at two different concentrations during original and confirmatory experiments, without being seen at higher concentrations in these experiments. Thus, the effect seen can not be considered as dose-dependent or concentration driven. Hence, based on the results of these experiments and on standard evaluation criteria, it is concluded that FAT 21036/C was not mutagenic in this bacterial reverse mutation assay.
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