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EC number: 278-133-0 | CAS number: 75214-65-2
- 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:
- From November 28th to December 15th, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- The experiments were performed using similar methods to those described in HRC protocol MCB 104 adopting modifications found in 'On concrete techniques for the mutagenicity test using micro-organisms' issued by the Japanese Ministry of Labour.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acid Black 222
- IUPAC Name:
- Acid Black 222
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 100 and TA 98
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Prof. B.N. Ames, University of California, Berkeley, California, U.S.A.
- Storage temperature: - 80 °C
- Storage conditions: amploules containing 0.8 ml of bacterial suspension and 0.07 ml of dimethylsulphoxide.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: rof. National Collection of lndustrial Bacteria, Aberdeen, Scotland.
- Storage temperature: - 80 °C
- Storage conditions: amploules containing 0.8 ml of bacterial suspension and 0.07 ml of dimethylsulphoxide.
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- Range findig experiment: 0, 100, 1000 and 10000 µg/plate
Main experiment: 0, 50, 100, 500, 1000, 5000 and 10000 µg/plate - Vehicle / solvent:
- Solvent: dimethylsulphoxide
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- methylmethanesulfonate
- other: 4-notro-o-phanylenediamine // 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: the compound was tested using the poured plate method.
TEST CONDITIONS: 0.1 ml of bacterial suspension; 0.1 ml of test solution, 0.5 ml of sodium phosphate buffer or S9 mix, 2.0 ml top agar.
INCUBATION: 72 hours at 37 °C
PREPARATION OF S9-MIX
- Storage temperature: -80 °C
- Animals: rat (Crl: COBS CD (SD) BR); males, weighting ca 200 grams and approximately 8 weeks old.
- Induction material: Araclor 1254 (a polychlorinoted biphenyl mixture).
- Induction administration: single interperitoneal injection.
- Induction dose level: 500 mg/kg bw
- Induction period: 5 days.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 100 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- With all five tester strains of S. typhimurium, test item, both in the presence and absence of liver microsomal fraction, provoked large dose related increases in revertant colony numbers.
With tester strain E. coli WP2 uvr, test item did not produce any substantial increases in revertant colony numbers.
Any other information on results incl. tables
Main test - Mean revertant colony counts obtained per plate using S. typhimurium strains TA 1535, TA 1597, TA 1538, TA 98 and TA 100 and E. coli strain WP2 uwA
Test concentration µ/plate | S9 mix | Reverse mutation (number of colonies/plate) | |||||
Base pair exchange type | Frame shift type | ||||||
TA 100 | TA 1535 | WP2 uvrA | TA 98 | TA 1537 | TA 1538 | ||
Solvent control | - | 71 | 10 | 25 | 24 | 6 | 14 |
Test item, 10000 | - | 307 p | 6p | 20 p | 61 p | 3 p | 0 p |
Test item, 5000 | - | 259 | 7 | 23 | 67 | 19 | 6 |
Test item, 1000 | - | 359 | 17 | 25 | 124 | 21 | 185 |
Test item, 500 | - | 242 | 20 | 21 | 99 | 23 | 167 |
Test item, 100 | - | 160 | - | 11 | 68 | 13 | 86 |
Test item, 50 | - | 117 | 11 | 17 | 44 | 12 | 50 |
Solvent control | + | 88 | 13 | 12 | 22 | 9 | 12 |
Test item, 10000 | + | 120 p | 80 p | 14 p | 70 p | 20 p | 30 p |
Test item, 5000 | + | 321 | 56 | 22 | 108 | 47 | 76 |
Test item, 1000 | + | 369 | 33 | 27 | 129 | 35 | 196 |
Test item, 500 | + | 283 | 75 | 22 | 107 | 28 | 125 |
Test item, 100 | + | 162 | - | 16 | 58 | 19 | 58 |
Test item, 50 | + | 112 | 17 | 13 | 40 | 10 | 35 |
Methyl methane sulphonate, 500 | - | 894 | |||||
N-ethyl-N'-nitro-N-nitrosoguanidine, 10 | - | 164 | |||||
N-ethyl-N'-nitro-N-nitrosoguanidine, 5 | - | 1636 | |||||
2-nitrofluorene, 2 | - | 2737 | |||||
9-amino-acridine, 10 | - | 92 | |||||
4-nitro-o-phenylenediamine, 10 | - | 861 | |||||
2-amino-anthracene, 0.5 | + | 1164 | 726 | 51 | |||
2-amino-anthracene, 1 | + | 80 | 53 | ||||
2-amino-anthracene, 40 | + | 224 |
Dose range finding test - Revertant colony counts obtained
Test concentration µ/plate | S9 mix | Reverse mutation (number of colonies/plate) | ||||
Bose pair exchange type | Frame shift type | |||||
TA 100 | TA 1535 | TA 98 | TA 1537 | TA 1538 | ||
Solvent control | - | 58 | 5 | 18 | 9 | 10 |
Test item, 10000 | - | 218 | 19 | 49 | 3 | 13 |
Test item, 1000 | - | 271 | 17 | 102 | 29 | 173 |
Test item, 100 | - | 87 | 6 | 48 | 9 | 65 |
Test item, 10 | - | 79 | 14 | 28 | 9 | 21 |
Solvent control | + | 72 | 4 | 9 | 5 | 9 |
Test item, 10000 | + | 203 | 5 | 127 | 38 | 35 |
Test item, 1000 | + | 297 | 23 | 93 | 32 | 178 |
Test item, 100 | + | 132 | 16 | 61 | 17 | 99 |
Test item, 10 | + | 71 | 6 | 15 | 10 | 26 |
WP2 uvrA was not tested because strain failed to grow on day of test
Applicant's summary and conclusion
- Conclusions:
- Test item showed evidence of strong mutagenic potential when tested in the bacterial system.
- Executive summary:
Microbial metabolic activation test was conducted to assess the potential mutagenic effect of the test item, using Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 100 and TA 98 strains and Escherichia coli WP2 uvrA strain. The experiments were performed using similar methods to those described in HRC protocol MCB 104 adopting modifications found in 'On concrete techniques for the mutagenicity test using micro-organisms' issued by the Japanese Ministry of Labour.
Dimethylsulphoxide was used as solvent. The substance was tested at concentrations of 0 (solvent), 50, 100, 500, 1000, 5000 and 10000 µg/plate. Adequate positive controls were also assayed.
With all five tester strains of S. typhimurium, test item, both in the presence and absence of liver microsomal fraction, provoked large dose related increases in revertant colony numbers.
With tester strain E. coli WP2 uvrA, test item did not produce any substantial increases in revertant colony numbers.
Conclusion
Test item showed evidence of strong mutagenic potential when tested in the bacterial system.
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