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EC number: 939-382-7 | 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Salmonella/Mammalian-Microsome Mutagenicity Assay. The experimental materials, methods, and procedures are based on those described by Ames et al. (Ames, B. N., McCann, J., and Yamasaki, E. (1975) Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutat. Res. 31, 347-364).
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- trisodium 6-[(1E)-2-(2,4-diaminophenyl)diazen-1-yl]-3-[(1E)-2-[4-({4-[(1Z)-2-{7-[(1E)-2-(2,4-diaminophenyl)diazen-1-yl]-1-hydroxy-3-sulfonatonaphthalen-2-yl}diazen-1-yl]-2-sulfonatophenyl}amino)phenyl]diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate
- EC Number:
- 939-382-7
- Molecular formula:
- not applicable
- IUPAC Name:
- trisodium 6-[(1E)-2-(2,4-diaminophenyl)diazen-1-yl]-3-[(1E)-2-[4-({4-[(1Z)-2-{7-[(1E)-2-(2,4-diaminophenyl)diazen-1-yl]-1-hydroxy-3-sulfonatonaphthalen-2-yl}diazen-1-yl]-2-sulfonatophenyl}amino)phenyl]diazen-1-yl]-4-hydroxynaphthalene-2-sulfonate
- Details on test material:
- Former EC 229-326-3
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 1538, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9 and Hamster S9
- Test concentrations with justification for top dose:
- Replicate 01: 100, 333, 1000, 3333, 10000 µg/plate
Replicate 02: 1.0, 3.3, 10, 33, 100, 333, 1000, 3333, 10000 µg
PREINCUBATION METHODOLOGY UNDER REDUCTIVE CONDITIONS: 1.0, 3.3, 10, 33, 100, 333, 1000, 3333, 10000 µg - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: H2O
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- PREINCUBATION METHODOLOGY UNDER REDUCTIVE CONDITIONS
- Positive control substance:
- congo red
- Details on test system and experimental conditions:
- CULTURE
Cultures were grown overnight in Oxoid nutrient broth no. 2 and were removed from incubation when they reached a density of (1-2) x 10^9 cells/mL. On the day of use, all tester strain cultures were checked for genetic integrity
S9 PREPARATION
Liver S9 homogenate was prepared from male Sprague-Dawley rats and Syrian golden hamsters that had been injected with Aroclor 1254 at 500 mg/kg body weight. The post-mitochondrial (microsomal) enzyme fractions were prepared.
The components of the S9 mix were:
8 mM MgCl2
33 mM KCl
5 mM glucose-6-phosphate
4 mM NADP
100 mM sodium phosphate (pH 7.4)
and the appropriate S9 homogenate at a concentration of 0.1 mL/mL of mix.
For each plate receiving microsomal enzymes, 0.5 mL of S9 mix was added.
PLATE INCORPORATION METHODOLOGY.
For testing in the absence of S9 mix, 100 µL of the tester strain and 50 µL of the solvent or test chemical were added to 2.5 mL of molten selective top agar at 45 ± 2°C. When S9 was used, 0.5 mL of S9 mix, 50 µL of tester strain, and 50 µL of solvent or test chemical were added to 2.0 mL of molten selective top agar at 45 ± 2 °C.
After it was vortexed, the mixture was overlaid onto the surface of 25 mL of minimal bottom agar. After the overlay had solidified, the plates were incubated for 48 h at 37 ± 2°C. Five doses of test chemical, together with the appropriate concurrent solvent and positive controls, were tested in triplicate on each tester strain without metabolic activation and also with activation by induced rat and hamster liver S9 preparations.
The doses that were tested in the mutagenicity assay were selected based on the levels of cytotoxicity observed in a preliminary dose range-finding study using strain TA100. Ten dose levels of the chemical, one plate per dose, were tested in both the presence and the absence of induced hamster S9. If no toxicity was observed, a total maximum dose of 10 mg of test chemical per plate was used.
PREINCUBATION METHODOLOGY UNDER REDUCTIVE CONDITIONS
For tests using the FMN-modified assay, strains TA98 and TA100 were used. The bacteria, uninduced hamster liver S9 (30% v/v), cofactors (FMN, NADH, glucose-6-phosphate dehydrogenase, and glucose-6-phosphate), and test chemical were added, mixed, and incubated at 30 °C for 30 min without shaking. Nitrogen was blown over the preincubation tube to keep the atmosphere reduced. At the end of the incubation period, 2 mL of molten top agar was added to each sample tube and the mixture was poured on a minimal agar plate containing 0.5% glucose rather than the 2% glucose. The plates were then incubated at 37 °C for 48 h.
The positive control in all FMN experiments was Congo red. All plates were counted with an Artek automated colony counter (Artek 880, DynaTech, Chantilly, VA) or Minicount colony counter (Imaging Products International, Inc., Chantilly, VA), which was calibrated prior to use. - Evaluation criteria:
- The criteria used to evaluate a test were as follows: for a test article to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose response to increasing concentrations of the test chemical. If the study showed a dose response with a less than 3-fold increase on TA1537 or TA1538, the response had to be confirmed in a repeat experiment
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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
Any other information on results incl. tables
Dose | TA98 | TA100 | TA1535 | TA1537 | TA1538 | ||||||||||
no S9 | rat S9 | Ham'r S9 | no S9 | rat S9 | Ham'r S9 | no S9 | rat S9 | Ham'r S9 | no S9 | rat S9 | Ham'r S9 | no S9 | rat S9 | Ham'r S9 | |
REPLY 01 | |||||||||||||||
Pos | Pos | Pos | Neg | Neg | Pos | Neg | Neg | Neg | Neg | Pos | Pos | Pos | Pos | Pos | |
H2O | 20 ± 5 | 20 ± 3 | 27 ± 4 | 87 ± 6 | 88 ± 5 | 104 ± 10 | 17 ± 6 | 11 ± 2 | 6 ± 2 | 7 ± 3 | 5 ± 1 | 6 ± 3 | 12 ± 4 | 19 ± 3 | 18 ± 6 |
100ug | 26 ± 2 | 97 ± 9 | 218 ± 22 | 94 ± 11 | 115 ± 3 | 102 ± 4 | 24 ± 1 | 10 ± 4 | 10 ± 3 | 7 ± 1 | 10 ± 4 | 18 ± 1 | 30 ± 5 | 172 ± 33 | 316 ± 15 |
333ug | 38 ± 4 | 370 ± 18 | 814 ± 9 | 90 ± 19 | 167 ± 4 | 128 ± 9 | 20 ± 2 | 12 ± 2 | 16 ± 6 | 6 ± 1 | 26 ± 3 | 47 ± 6 | 46 ± 6 | 621 ± 34 | 996 ± 145 |
1000ug | 62 ± 6 | 221 ± 60 | 346 ± 102 | 88 ± 10 | 101 ± 12 | 117 ± 19 | 20 ± 8 | 10 ± 2 | 7 ± 6 | 8 ± 2 | 21 ± 5 | 14 ± 2 | 87 ± 12 | 493 ± 77 | 807 ± 317 |
3333ug | 73 ± 7 | --- | --- | 94 ± 3 | 122 ± 20 | 120 ± 16 | 17 ± 6 | 9 ± 4 | 9 ± 2 | 9 ± 5 | 11 ± 4 | 13 ± 2 | 129 ± 19 | --- | --- |
10000ug | 79 ± 18 | --- | --- | 93 ± 21 | 112 ± 18 | 122 ± 15 | 18 ± 3 | 8 ± 1 | 9 ± 3 | 12 ± 5 | 11 ± 3 | 13 ± 2 | 79 ± 16 | --- | --- |
Positive | 557 ± 21 | 718 ± 76 | 2136 ± 57 | 1191 ± 27 | 728 ± 76 | 2027 ± 113 | 1332 ± 188 | 386 ± 41 | 314 ± 8 | 492 ± 128 | 613 ± 19 | 238 ± 26 | 857 ± 124 | 808 ± 138 | 2233 ± 77 |
REPLY 02 | |||||||||||||||
H2O | 13 ± 4 | 15 ± 5 | 23 ± 2 | 101 ± 6 | 122 ± 14 | 156 ± 18 | 7 ± 1 | 7 ± 3 | 21 ± 4 | 28 ± 5 | |||||
1.0ug | --- | 21 ± 5 | 39 ± 7 | --- | 123 ± 9 | 158 ± 6 | |||||||||
3.3ug | --- | 40 ± 10 | 68 ± 7 | --- | 122 ± 2 | 174 ± 9 | 7 ± 3 | 6 ± 4 | 38 ± 7 | 42 ± 5 | |||||
10ug | 19 ± 2 | 46 ± 8 | 126 ± 10 | 105 ± 3 | 149 ± 12 | 165 ± 24 | 10 ± 1 | 10 ± 2 | 48 ± 9 | 61 ± 10 | |||||
33ug | 26 ± 2 | 153 ± 23 | 306 ± 99 | 99 ± 8 | 194 ± 10 | 195 ± 7 | 6 ± 2 | 8 ± 4 | 88 ± 12 | 118 ± 18 | |||||
100ug | 33 ± 2 | 238 ± 51 | 264 ± 67 | 94 ± 17 | 224 ± 21 | 258 ± 11 | 10 ± 3 | 15 ± 2 | 241 ± 33 | 331 ± 54 | |||||
333ug | 72 ± 4 | 320 ± 109 | 402 ± 121 | 119 ± 7 | 224 ± 29 | 350 ± 21 | 18 ± 2 | 46 ± 7 | 787 ± 39 | 1648 ± 75 | |||||
1000ug | 97 ± 11 | 115 ± 11 | 154 ± 47 | 121 ± 12 | 128 ± 20 | 189 ± 10 | 250 ± 4 | 373 ± 7 | 683 ± 142 | 1306 ± 204 | |||||
3333ug | 110 ± 10 | 96 ± 11 | 141 ± 14 | 127 ± 12 | 133 ± 11 | 164 ± 10 | |||||||||
10000ug | 93 ± 12 | 206 ± 68 | 173 ± 32 | 134 ± 10 | 131 ± 8 | 158 ± 6 |
PREINCUBATION METHODOLOGY UNDER REDUCTIVE CONDITIONS
Dose | TA98 | TA100 | ||||
no S9 | rat S9 | Ham'r S9 | no S9 | rat S9 | Ham'r S9 | |
H2O | 12 ± 1 | 25 ± 3 | 30 ± 5 | --- | --- | 157 ± 8 |
1.0ug | --- | 29 ± 3 | 37 ± 8 | --- | --- | 161 ± 11 |
3.3ug | --- | 38 ± 11 | 92 ± 1 | --- | --- | 144 ± 12 |
10ug | 21 ± 4 | 72 ± 11 | 188 ± 40 | --- | --- | 183 ± 21 |
33ug | 26 ± 5 | 221 ± 22 | 654 ± 105 | --- | --- | 262 ± 13 |
100ug | 59 ± 13 | 499 ± 45 | 1159 ± 101 | --- | --- | 325 ± 8 |
333ug | 86 ± 8 | 563 ± 107 | 1125 ± 47 | --- | --- | 283 ± 25 |
1000ug | 100 ± 15 | 135 ± 34 | 305 ± 113 | --- | --- | 180 ± 11 |
3333ug | 154 ± 4 | 117 ± 47 | 207 ± 91 | --- | --- | 177 ± 5 |
10000ug | 162 ± 14 | 115 ± 20 | 152 ± 25 | --- | --- | 163 ± 18 |
Positive | 391 ± 19 | 1410 ± 109 | 151 ± 159 | --- | --- | 185 ± 23 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results positive
- Executive summary:
AMES test was performed on Direct Black 22 The experimental materials, methods, and procedures are based on those described by Ames et al. (Ames, B. N., McCann, J., and Yamasaki, E. (1975) Methods for detecting carcinogens and mutagens with the Salmonella/mammalian microsome mutagenicity test. Mutat. Res. 31, 347-364).
Result
P/3.3: positive
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