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A mixture of: disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(ethensulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex; disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(2-hydroxyethylsulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex
EC number: 423-940-7 | CAS number: 85585-91-7 PACIFIED REACTIVE BLACK 31
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 November 1995 to 24 January 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- A mixture of: disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(ethensulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex; disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(2-hydroxyethylsulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex;
- EC Number:
- 423-940-7
- EC Name:
- A mixture of: disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(ethensulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex; disodium 6-[3-carboxy-4,5-dihydro-5-oxo-4-sulfonatophenyl)pyrazolin-4-yl-azo]-3-[2-oxido-4-(2-hydroxyethylsulfonyl)-5-methoxyphenylazo]-4-oxidonaphthalene-2-sulfonate copper (II) complex;
- Cas Number:
- 85585-91-7
- IUPAC Name:
- 4-[2-(7-{2-[4-(ethenesulfonyl)-2-hydroxy-5-methoxyphenyl]diazen-1-yl}-8-hydroxy-6-sulfonaphthalen-2-yl)diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylic acid 4-[2-(8-hydroxy-7-{2-[2-hydroxy-4-(2-hydroxyethanesulfonyl)-5-methoxyphenyl]diazen-1-yl}-6-sulfonaphthalen-2-yl)diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylic acid dicopper tetrasodium hydride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Identification: Pacified Reactive Black 31
Description: Dark blue crystals
Batch: 9T-55
Purity: 89%
Storage: At room temperature in the dark
Stability in vehicle: Stable in water for at least 96 hours
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: Human
- Details on mammalian cell type (if applicable):
- Blood samples were taken from a healthy male adult. Samples were stored at a temperature of between 4 and 25°C,
- Cytokinesis block (if used):
- Foloowing treatment, cell division was arrested in the metaphase stage of the cell cycle by additin of the spindle poison cochicine.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochloe 1254 induced rate liver S9-mix
- Test concentrations with justification for top dose:
- Dose range-finding test
100, 333, 100, 3330 and 5000 µg/ml culture medium - with and without S9 mix.
Experiment 1
Without S9-mix:
24-hour fixation period100, 333, 1000, 1335, 1778 and 3330 µg/ml culture medium
48 hour fixation time: 333, 1000, 1334, 4778 and 3330 µg/ml culture medium
With S9 mix
24-hour fixation time: 100, 333, 562, 1000, 1778 and 3330 µg/ml culture medium
48-hour fixation time: 562, 1000, 1778 and 3330 µg/ml culture medium
Experiment 2
Without S9-mix:
24-hour fixation time: 100, 333, 1000, 1334, 1778 and 3330 µg/ml culture medium
With S9 mix
24-hour fixation time; 100, 333, 1000, 3330 and 5000 µg/ml culture medium - Vehicle / solvent:
- The test substance was dissolved in F10 complete culture medium.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Vehicle of test article, being F10 complete culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle of the test article, being F10 complete culture medium
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Cytogenic assay
The test substance was tested in the absence and presence of S9-mix in duplicate in two independemt expeiments.
Lymphocyte cultures were cultured for 48 hours and thereafter exposed in duplicate to selected doses of the test substance for 24 hours and 48 hours in the absence of S9 mix or for 3 hours in the presence of S9 mix.
The total volume of exposition medium was 7.5 ml. In the presence of S9-mix 1.93 ml and in the absence of S9-mix 2 ml test substance (dissolved in culture medium) were added.
After 3 housr treatment, the cells exposed to the test substance in the presence of S9-mix were rinsed once with 5 ml of HBSS and incubated in 5 ml culture medium for another 20-22 hours (24 hours fixation time) or for 44-46 hours (48 hours fixation time).
The cells which were treated for 24 hours and 48 hours in the absence of S9-mix were not rinsed after treatment but were worked up immediately after 24 hours and 48 hours (24 and 48 hours fixation time).
During the last 3 hours of the culture period, cell division was arrested by addition of the spindle inhibtor, cohicine (0.5 µg/ml medium). Thereafter the cell cultures were centrifuged for 5 minutes at 1300 rpm and the supernatant was removed. Cells in the remaining cell pellet were swollen by a 5 minute treatment with hypotonic potassium chloride solution at 37°C. After hypotonic treatment, cells were fixed with 3 changes of metjanol: acetic acid fixative (3:1 v/v).
Based on the mitotic index of the dose range finding test and the first experiment, appropriate dose levels were chosen for the scond experiment. For the independent repeat the 24 hour fixation time is needed only. - Rationale for test conditions:
- Based on the results of the dose range-finding test an appropriate range of dose levels was chosen for the cytogenic assay.
- Evaluation criteria:
- Acceptability of Assay
A chromosome aberration test is considered acceptable if it meets the following criteria:
a) The numbers of chromsoome aberrations found in the solvent control cultures should reasonable be within the laboratory historical control data range,
b) The positive control substances should prodice a statisically signficant increase in the number of cells with chromsome aberrations.
c) A homogenous response between the replicate cultures is observed.
A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) It induced a dose-related statistically significant (Chi square test, P < 0.05) increase in the number of cells with chromosome aberrations.
b) A statistically significant increase in the frequency of aberrations was observed in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic) in the chromosme aberration test if:
a) None of the tested concentrations induced a statistically significant (Chi-square test, P < 0.05) increase in the number of cells with chromosome aberrations. - Statistics:
- Chi-square statistics
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: Human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Both in the absence and presence of S9 mix Pacified Reactive Black 31 did not induce a statistically significant increase in the number of cells with chromosome aberrations.
The number of cells with chromosome aberrations found in the solvent control cultures were within the laboratory historical control data range.
The positive control chemials both produced statistically significant increases in the frequency of aberrant cells. It was therefore concluded that the test conditions were adequate and the the metabolic activation system functioned properly. - Remarks on result:
- other: Not clastogenic
Applicant's summary and conclusion
- Conclusions:
- This test should be considered valid and Pacified Reactive Black 31 is not clastogenic under the experimentaconditions of this test.
- Executive summary:
In the absence of S9 -mix Pacified Reactive Black 31 was tested up to 1778 µg/ml for a 25 hour and 48 hour fixation time in the first experiment. In the second experiment, it was tested up to 1334 µg/ml for a 24 -hour fixation time.
In the presence of 1.8% (v/v) S9 -fraction Pacified Reactive Black 31 was tested up to 3330 µg/ml for a 24 -hour and 48 -hour fixation period in the first experiment. In the second experiment, it was tested up to 3330 µg/ml for a 24 -hour fixation period.
None of the tested concentrations induced a statistically significant and biologically significant increase in the number of cells with chromosome aberrations, neither in the absence nor in the presence of S9 -mix.
Both positive control chemicals produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9 -mix) functioned proerly.
It is concluded that Pacified Reactive Black 31 is not clastogenic in human lymphocytes under the experimental conditions of this study.
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