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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 November 1995 to 30 November 1995
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age at start of treatment: Approximately 8 weeks
Body weight at start of treatment: Within +/- of the sex mean
Number of animals: 5 males and 5 females
Identification: Earmark
Conditions
Air-conditioned room with approximately 15 air changes per hour amd the environment controlled with optimal conditions considered as being a temperature of 21°C and a relative humidity of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artifical fluorescent light and 12 hours dark per day.
Accomodation
Individually housed in polycarbonate cages containing purified sawdust as bedding material. Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to standard pelleted laboratory animal diet. Certificates of analysis were examined and then retained in the NOTOX archives,
Water
Free access to tap water. Certificates of analysis (performed quarterly) were examined and then retained in the NOTOX archives,.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- Shaving
One day before exposure (Day 1) and area of approximately 5 x 7 cm on the back of the animal was clipped.
Application
The formulation was applied to an area of approximately 25 cm2 (5 x 5 cm) for males and 18 cm2 (3.5 x 5 cm) for females by application on a gauze pacth fixed succesively to aluminium foil and flexible bandage., with drops of petrolatum.
Frequency
Once, on Day 1
Application period
24 hours, thereafter dressings were removed and residual test substance was removed using a tissue moistened with tap water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
Volume: 10 ml/kg bw - No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- Observations
Mortality/ viability
Twice daily
Body weights
Days 1 (pre-administration), 8 and 15
Clinical signs
At periodic intervals on the day of treatment (Day 1) and once daily thereafter, until Day 15. The time of onset, degree and duration were recorded.
Necropsy
At the end of the observation period, all animals were sacrificed by oxygen/ carbon dioxide asphyxiation and subjected to necropsy. Descriptions of all internal macropscopic abnormalities were recorded. - Statistics:
- No statistical analyses were performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No animals died during the study
- Clinical signs:
- other: Red staining of the snout was observed among four animals between days 1 to 4 and in the neck region of one female on Day 12. During exposure, black staining of the neck region at the border of the bandages was apparent in the majority of animals and bla
- Gross pathology:
- No abnormalties were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of Pacified Reactive Black 31 in rats was established as exceeding 2000 mg/kg bw.
- Executive summary:
The study was carried out in accordance with OECD Guideline No. 402, "Acute dermal toxicity" and EEC Directive 92/69/EEC, Part B.3, "Acute Toxicity - Dermal".
Pacified Reactive Black 31 was administered to five rats of each sex dy dermal application of 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determinatons of bodyweight. Macropscopic examination was performed at the the endof th experimental period - Day 15.
No animals died during the study
During exposure, black staining of the neck region at the border of the bandages was apparent in the majority of animals and black staining of the snout in one animal.
Black staining was seen in the treated skin-area of all animals during the observation period and persisted until Day 15.
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study amd were therefore considered not toxicologicaly significant.
No abnormalities were found in the animals at macroscopic post mrtem examination.
The dermal LD50 value of Pacified Reactive Black 31 in rats was established as exceeding 2000 mg/kg bw.
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