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EC number: 274-999-9 | CAS number: 70900-27-5
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 June 2015 to 23 July 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)bis[imino(3-methylpropane-1,3-diyl)]]bis(benzenesulphonate)
- Cas Number:
- 70900-27-5
- IUPAC Name:
- Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)bis[imino(3-methylpropane-1,3-diyl)]]bis(benzenesulphonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Blue powder
- Storage conditions of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: MB-140715
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable (Not reactive to light nor to air)
- Solubility and stability of the test substance in the solvent/vehicle: 100 g/L solubility and stable in water.
Method
- Target gene:
- Histidine requirement in the Salmonella typhimurium strains (Histidine operon).
Tryptophan requirement in the Escherichia coli strain (Tryptophan operon).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- n/a
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- 5000 μg/plate dose was selected as the top dose for all strains, both with and without metabolic activation. This highest dose was diluted 4 times (using a common ratio of 2) to provide a total of 5 dose levels. The 5 dose levels selected for the main test were 313, 625, 1250, 2500 and 5000 μg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: Based on the information provided by the sponsor, the test substance was soluble at 100 g/L in water. Therefore water for injection was used as solvent for preparation.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- furylfuramide
- other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine · 2HCl, 2-Aminoanthracene,
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- For the tests without metabolic activation, 0.5 mL of 0.1 M Na-phosphate buffer (pH 7.4) and 0.1 mL of each fresh bacterial culture were added to each tube containing 0.1 mL of the test solution or the negative control solution. For the tests with metabolic activation, 0.5 mL of the S9 mix was added to each tube instead of the 0.1 M Na-phosphate buffer. The mixture was pre-incubated in a water bath at 37°C for 20 minutes while shaking horizontally, and then 2.0 mL of top agar were added to the mixture, and the contents of each tube were poured over the surface of the minimal glucose agar plate.
One minimal glucose agar plate was used for each dose level in the preliminary test and three minimal glucose agar plates were used for each dose level in two main test which were performed at the same doses.
For the sterility test, 0.1 mL of the test solution of the maximum concentration and 0.5 mL of the S9 mix were put into each tubed, 2.0 mL of top agar was then added to the tube and the contents of each tube were poured over the surface of the minimal glucose agar plate.
These operations were conducted under lamps with ultraviolet absorbent filter.
- As top agar, 0.5 mM biotin-0.5 mM L-histidine solution and the 0.5 mM L-tryptophan solution were added to the soft agar solution (0.6% Agar and 0.5% NaCl) by volume of 1/10, for the S. typhimurium TA strains and the E.coli strain, respectively.
DURATION
- All plates were incubated at 37°C for 48 hours, and the number of revertant colonies was counted. Afterwards, growth inhibition of the test strains was checked using a stereoscopic microscope.
NUMBER OF REPLICATIONS: Plated in triplicate
OTHER: Counting procedure - The number of revertant colonies was counted visually due to the color of the test substance on the plates. But the revertant colonies of positive controls were counted with a colony counter. - Evaluation criteria:
- In the two main tests, experiment 1 and 2, if the number of revertant colonies on the test plates increased significantly in comparison with that on the control plates (based on twice as many as that of the negative control), and dose-response and reproducibility were also observed, the test substance was to be judged positive. The results at each concentration were demonstrated through the mean and the standard deviation.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- 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:
- In the preliminary test, the growth inhibition by the test substance was not observed in any strains either with or without metabolic activation. And the precipitate of the test substance on the plates was not observed either with or without metabolic activation.
In the two main tests, neither an increase in the number of revertant colonies (more than twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains of base-pair substitution type or frame-shift type, with or without metabolic activation. The revertant colonies of the positive controls showed an increase of more than twice that of the negative controls and they were within limit of controls (mean ± 3 SD) , indicating that this study was performed correctly.
From these results, mutagenicity of the test substance was judged negative.
The growth inhibition of the test strains by the test substance was not observed. And the precipitate of the test substance on the plates was not observed either with or without metabolic activation.
In the sterility test on the test solution and the S9 mix, no growth of bacteria was observed.
Any other information on results incl. tables
Summary of Experiment 1
± S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
Solvent 313 625 1250 2500 5000
|
107 103 113 107 95 106 |
16 13 13 13 11 14
|
35 37 29 31 29 29
|
28 24 24 30 23 25 |
10 8 7 8 6 7
|
+ |
Solvent 313 625 1250 2500 5000
|
115 138 111 104 109 104
|
11 12 12 9 9 10 |
33 35 36 31 28 33 |
34 32 32 25 29 33
|
15 15 16 18 16 16 |
Positive Controls |
||||||
- |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
|
Mean no. colonies/plate |
556 |
392 |
145 |
539 |
1950 |
|
+ |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
Concentration (µg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
50 |
|
Mean no. colonies/plate |
854 |
317 |
371 |
228 |
84 |
Summary of Experiment 2
± S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||
- |
Solvent 313 625 1250 2500 5000
|
117 116 102 103 107 97 |
18 13 15 13 13 12
|
37 32 28 25 27 25 |
25 20 30 28 24 23 |
10 7 7 9 10 9 |
+ |
Solvent 313 625 1250 2500 5000
|
124 131 120 109 118 99 |
12 15 13 12 10 12 |
35 37 30 30 29 28 |
36 41 38 31 36 36 |
22 25 24 25 24 23 |
Positive Controls |
||||||
- |
Name |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Concentration (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
|
Mean no. colonies/plate |
554 |
449 |
147 |
550 |
1617 |
|
+ |
Name |
B[a]P |
2AA |
2AA |
B[a]P |
B[a]P |
Concentration (µg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
50 |
|
Mean no. colonies/plate |
896 |
335 |
417 |
241 |
89 |
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3 = Sodium azide
ICR-191 = 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine · 2HCI
B[a]P = Benzo[a]pyrene
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material was concluded to be negative with regard to genotoxicity in the Bacterial Gene Mutation Assay.
- Executive summary:
The mutagenic activity of the test material was evaluated in a bacterial reverse mutation assay conducted using a protocol written to comply with the standardised guideline OECD 471 and Japanese Guidelines for Screening Mutagenicity Testing Of Chemicals under GLP conditions.
S. typhimurium tester strains TA98, TA100, TA1535 and TA1537 and E.coli tester strain WP2uvrA were exposed to the test material in the presence and absence of Phenobarbital (PB) and 5,6-benzoflavone (BF)-induced rat liver S9 using the plate incorporation method. Following a preliminary assay, 2 mutagenicity assays (Experiment 1 and 2) were used to evaluate the mutagenic potential of the test material at concentrations of 0, 313, 625, 1250, 2500 and 5000 µg/plate using water for injection as the vehicle. Appropriate vehicle and positive controls for each tester strain were evaluated concurrently. All dose levels of test material, vehicle controls and positive controls were plated in triplicate.
No precipitate or cytoxicity was observed in the experiments. In the main mutagenic tests, experiment 1 and 2, no positive responses were observed with any of the tester strains in the presence and absence of S9 activation. All criteria for a valid study were met.The results indicate that under the conditions of this study the test material did not cause a positive response with any of the tester strains in the presence and absence of Phenobarbital (PB) and 5,6-benzoflavone (BF)-induced rat liver S9.
Under the conditions of this study, the test material was concluded to be negative with regard to genotoxicity in the Bacterial Gene Mutation Assay.
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