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EC number: 944-699-9 | CAS number: -
- 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
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- 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
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer chapter 13 for detailed read across justification.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
- EC Number:
- 216-475-4
- EC Name:
- 1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone
- Cas Number:
- 1594-08-7
- Molecular formula:
- C21H15NO6S
- IUPAC Name:
- 4-[(4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]phenyl methanesulfonate
- Test material form:
- not specified
- Details on test material:
- None
Constituent 1
Method
- Target gene:
- The experiments were performed to detect any properties of the test material or its metabolites to induce gene mutations in histidine-requiring strains of Salmonella typhimurium.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 fraction
- Test concentrations with justification for top dose:
- - Range in the cytotoxity test: 20.6 - 5000 µg/plate.*
- Range in the original mutagenicity test: 61.7 - 5000 µg/plate.*
- Range in the confirmatory mutagenicity test: 88.95 - 7205 µg/plate.**
*The purity of the tested batch is 69.4%. Related to 100% purity the highest concentration in these parts of the assay was 3470 jug/plate.
** Related to 100% purity the highest concentration in this part of the assay was 5000 jug/plate. - Vehicle / solvent:
- Dimethylsulfoxyde.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- mitomycin C
- other: Sodium azide and 9 (5) - aminoantharcene
- Remarks:
- Without microsomal activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- other: 2-aminoanthracene
- Remarks:
- With microsomal activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Exposure duration: 48 at 37°C
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
NUMBER OF REPLICATIONS: Triplicate plating.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn. - 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 judgment 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 (Ref. 1) 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
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- slight increase of the number of revertant colonies at the concentration of 5000 and 7205 µg/mL in the original and in the confirmatory experiment.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: TA 1535, TA 98 TA 100 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- Original and confirmatory experiment.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: TA 98 and TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- a slight increase in the number of back-mutants occured at the concentration of 5000 µg/Ll.(original experiment)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: TA 1537; TA 100 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- Original experiment
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Confirmatory experiment
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: TA 98, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- a slight increase in the number of back-mutants at the concentration of 7205 µg/ml (Confirmatory experiment)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Toxicity test/Range finding test
Six concentrations of Terasil Violett BL roh feucht (FAT 3 6038/F) ranging from 20.6 to 5000 /ng/plate were tested with strain
S. typhimurium TA 100 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 were 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 first mutagenicity test was selected to be 5000 /xg/plate without and with activation.
Mutagenicity test, original experiment
(concentration range: 61.7 to 5000 microg/plate)
In the experiment carried out with metabolic activation, treatment of strain TA 1537 with Terasil Violett BL roh feucht (FAT 36038/F) led to a slight increase in the number of revertant colonies at the concentration of 5000 microg/ml. No effects were observed with the other strains. In the experiment performed without activation, a slight increase in the
number of back-mutants occurred on strains TA 98 and TA 1535 at the concentration of 5000 microgr/ml. No effects were observed with the other strains.
Mutagenicity test, confirmatory experiment
(concentration range: 88.95 to 7205 /microg/plate)
In the experiment carried out with metabolic activation, treatment of strain TA 1537 with Terasil Violett BL roh feucht (FAT 36038/F), led to a slight increase in the number of revertant colonies at the concentration of 7205 /Ltg/ml. No effects were observed with the other strains. In the experiment performed without activation, a slight increase in the number of back-mutants occurred on strains TA 98, TA 1535 and TA 1537 at the concentration of 7205 /microg/ml. No effects were observed with the other strains.
Owing to a toxic effect of the test material in the mutagenicity tests without metabolic activation on strain TA 102, a slight decline in the number of revertant colonies was observed at the upper concentrations. 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.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of these experiments and on standard evaluation criteria, it is concluded that Terasil Violet BL roh feucht (FAT 36038/F) exerted a weak mutagenic action on strains S. typhimurium TA 98 and TA 1535. The metabolites of the test material were weakly mutagenic with strain TA 1537.
- Executive summary:
A key study was performed to determine the detection of gene mutations induced by the test material FAT 36038/F or its metabolites in histidine-requiring strains of Salmonella typhimurium.
The FAT 36038/F) were tested for mutagenic effects without and with metabolic activation at five concentrations in the range of 61.7 to 5000 jug/plate.
In the experiment without and with metabolic activation no toxic effect of the test material on the growth of the bacteria was observed.
In the original experiment carried out with metabolic activation, treatment of strain TA 1537 with Terasil Violett BL roh feucht (FAT 36038/F) led to a slight increase in the number of revertant colonies at the highest concentration. No effects were observed with the other strains. In the experiment performed without activation, a slight increase in the number of back-mutants occurred on strains TA 98 and TA 1535 at the highest concentration. No effects were observed with the other strains.
In the confirmatory experiment carried out with metabolic activation, treatment of strain TA 1537 with Terasil Violett BL roh feucht (FAT 36038/F), led to a slight increase in the number of revertant colonies at the highest concentration. No effects were observed with the other strains. In the experiment performed without activation, a slight increase in the number of back-mutants occurred on strains TA 98, TA 1535 and TA 1537 at the highest concentration. No effects were observed with the other strains.
In the mutagenicity tests without metabolic activation performed on strain TA 102, a slight decline in the number of revertant colonies was registered. The test substance exerted a weak inhibiting effect on the growth of this bacterial strain.
Conclusion
Based on the results of these experiments and on standard evaluation criteria, it is concluded that Terasil Violett BL roh feucht (FAT 36038/F) exerted a weak mutagenic action on strains S. typhimurium TA 98 and TA 1535. The metabolites of the test material were weakly mutagenic with strain TA 1537.
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