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EC number: 481-170-7 | CAS number: 502453-61-4
- 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:
- 2006-12-06 to 2007-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 471 and GLP.
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:
- 2 007
- Report date:
- 2007
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:
- -
- EC Number:
- 481-170-7
- EC Name:
- -
- Cas Number:
- 502453-61-4
- Molecular formula:
- Hill formula: C23H30BrN3O2 CAS formula: C23H30N3O2.Br
- IUPAC Name:
- dimethyl(3-{[4-(methylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}propyl)propylazanium bromide
- Reference substance name:
- Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
- IUPAC Name:
- Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
- Details on test material:
- - Name of test material (as cited in study report): B119 HC Blue 16
- Molecular formula (if other than submission substance): C232H30N3O2.Br
- Molecular weight (if other than submission substance): 460.42
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: Active
- Physical state: Dark blue powder
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: see below
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: see below
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/B-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-experiment/experiment 1: 3, 10, 33, 100, 333, 1000, 2500, and 5000 ug/plate
Experiment 2 and 2A: 10, 33, 100, 333, 1000, 2500, and 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Deionised water
- Justification for choice of solvent/vehicle: On the day of the experiment, the test substance was suspended in deionised water. The solvent was chosen because of its solubility properties.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- deionised water
- True negative controls:
- yes
- Remarks:
- untreated
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation Migrated to IUCLID6: Used for strains TA1535 and TA100 (10 ug/plate)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- deionised water
- True negative controls:
- no
- Remarks:
- untreated
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine- used for strains TA1537 (10 ug/plate) and TA98 (50 ug/plate)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- deionised water
- True negative controls:
- yes
- Remarks:
- untreated
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation Migrated to IUCLID6: Used for strain TA102 (3 uL/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- deionised water
- True negative controls:
- no
- Remarks:
- untreated
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene- used for strains TA1535, TA1537, TA98, TA100 (2.5 ug/plate) and TA102 (10 ug/plate
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment 1-in agar (plate incorporation); experiment 2 and 2A-preincubation
DURATION
- Preincubation period: 60 minutes (experiment 2 and 2A only)
- Exposure duration: 48 hours
- Expression time (cells in growth medium): N/A
- Selection time (if incubation with a selection agent): N/A
- Fixation time (start of exposure up to fixation or harvest of cells): N/A
SELECTION AGENT (mutation assays): L-histidine
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for cytogenetic assays): N/A
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: N/A
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity of the test substance was measured by a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.
OTHER EXAMINATIONS:
- Determination of polyploidy: N/A
- Determination of endoreplication: N/A
- Other: N/A
OTHER: N/A - Evaluation criteria:
- The test substance was considered a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA102) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control was observed.
A dose dependent increase was considered biologically relevant if the threshold was exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration was judged at biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold was regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remained within the historical range of negative and solvent controls such an increase was not considered biologically relevant. - Statistics:
- According to OECD guideline 471, a statistical analysis of the data was not mandatory.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- 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, other: TA100, TA98, TA1535 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: N/A
- Effects of osmolality: N/A
- Evaporation from medium: N/A
- Water solubility: >20 weight % in water (pH 6.1)
- Precipitation: Precipitation of the test substance was observed in the test tubes from 1000 up to 5000 ug/plate in experiment 1 , and at 2500 and 5000 ug/plate in experiment 2 and 2A. No precipitation was observed on the agar plates.
- Other confounding effects:
RANGE-FINDING/SCREENING STUDIES: To evaluate the toxicity of the test substance a pre-experiment was performed with strains TA1535, TA1537, TA98, TA100 and TA102. Eight concentrations (3-5000 ug/plate) were tested for toxicity and mutation induction with each 3 plates. The experimental conditions in the experiment were the same as described for experiment 1 (plate incorporation test) listed above. Toxicity of the test substance was measured by a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. This pre-experiment was reported as main experiment 1 (see below for results), since the following criteria was met: Evaluable plates (>0 colonies) at five concentrations or more in all strains used. Based on the toxic effects observed in this experiment, the concentrations used for the second experiment were chosen.
COMPARISON WITH HISTORICAL CONTROL DATA: All positive, vehicle and untreated controls were within historical data ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: See below - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The plates incubated with the test substance showed normal background growth up to 5000 ug/plate with and without metabolic activation. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 5.0), were observed at the following concentrations (ug/plate):
/no toxic effects observed
In experiment 2, substantial and dose dependent increase in revertant colony numbers were observed following treatment with the test substance in TA1537 in the absence and presence of metabolic activation. The threshold of three times the number of the corresponding solvent control was exceeded at all concentrations equal to and greater than 33 ug/plate without activation and at at all concentrations equal to and greater than 333 ug/plate with activation. To verify these results this part of the second experiment was repeated under identical conditions using strain TA1537. Again, as in the second experiment substantial and dose dependent increases in revertant colony numbers were observed. The required threshold was already reached at 10 ug/plate and well exceeded at 33 ug/plate and above without activation. In the presence of metabolic activation the increase in revertant colony numbers started at100 ug/plate and exceeded the threshold of three times the number of the corresponding solvent control at 333 ug/plate and above. A reduction of the revertant colonies was observed at higher concentrations due to overlapping toxic effects. The remaining strains did not show any increase of the number of the revertant colonies. The repeat experiment was reported as experiment 2A. The positive controls showed a distinct increase in induced revertant colonies. |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with and without metabolic activation
This study was performed to investigate the potential of B119 HC Blue 16 to induce gene mutations according to the plate incorporation (experiment 1) test and to the pre-incubation test (experiment 2 and 2A) using the Salmonella typhimurium strains TA1535, TA1537,TA98, TA100 and TA102. During the described mutagenicity test and under the experimental conditions reported, the test substance induced gene mutations by frameshifts in the genome of the strain TA1537 in the absence and presence of metabolic activation. Therefore, the test substance was considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of B119 HC Blue 16 to induce gene mutations according to the plate incorporation (experiment 1) test and to the pre-incubation test (experiment 2 and 2A) using the Salmonella typhimurium strains TA1535, TA1537,TA98, TA100 and TA102.
The assay was performed with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test substacne was tested at the following concentrations:
Pre-experiment/experiment 1: 3, 10, 33, 100, 333, 1000, 2500, and 5000 ug/plate
Experiment 2 and 2A: 10, 33, 100, 333, 1000, 2500, and 5000 ug/plate
The plates incubated with the test substance showed normal background growth up to 5000 ug/plate with and without metabolic activation.
Toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation in nearly all strains used.
In experiment 2, substantial and dose dependent increases in revertant colony numbers were observed following treatment with the test substance in strain TA1537 in the absence and presence of metabolic activation. The threshold of three times the number of the corresponding solvent control was exceeded at 33 ug/plate and above without activation and at 333 ug/plate and above with activation. To verify these results this part of the second experiment was repeated under identical conditions using strain TA1537. Again, as in the second experiment substantial and dose dependent increases in revertant colony numbers were observed. The required threshold was already reached at 10 ug/plate and well exceeded at 33 ug/plate and above without activation. In the presence of metabolic activation the increase in revertant colony numbers started at 100 ug/plate and exceeded the threshold of three times the number of the corresponding solvent control at 333 ug/plate. The repeat experiment was reported as experiment 2A. The remaining strains did not show any increase in the number of the revertant colonies.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test substance induced gene mutations by frameshifts in the genome of the strain TA1537 in the absence and presence of metabolic activation. Therefore, the test substance was considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
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