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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 November 1995 to 10 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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
- 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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age at start of treatment
Approximately 8 0r 9 weeks
Body weight at start of treatment
1532 - 1691 grams
Identification
Ear tag
Conditions
Air-conditioned room with approximately 15 air changes per hour and 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 in labelled cages with protected floors and equipped with an automatic drinking system. Acclimatisation oeruid was at least 5 days before start of treatment under laboratory conditions.
Diet
Standard laboratory rabbit diet, approximately 100 g per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay was provided once a week.
Water
Free access to tap water diluted with decalcified water.
Certificates if analysis were examined and retained in the NOTOX archives..
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 gram of mositeed test material
- Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approximately 150 cm2.
the animals were examined, and the skin to be treated in particular, prior to test substance administration and no abnormalities were detected.
On test Day 1, 0.5 g if the test substance was moistened and subsequently applied to te intacj skin if the shaved area on one flank. A similar patch, but without test substance and water, was applied to the contralateral flank, to act as a procedural control. Both patches were mounted on tape, which was wrapped around the abdomen and secured with an elastic bandage.
Whenever considered necessary, the skin areas concerned of the animals we re-shaved at leat 3 hours before the observations, to facilitate the scoring.
Observations
Mortality/viability
Twice daily
Toxicity
At least once daily
Body weight
Day of treatment (prior to application)
Irritation
The skins reactions were assessed at approximately 1, 24, 48 and 72 hours after removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Noeffects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritant / corrosive response data:
- No skin irritation was caused by Pacified Reactive Black 31 after 4 hours of exposure in two animals. Very slight erythema was noted in the treated skin-area if the third animal, one hour after exposure only.
- Other effects:
- Colouration
Black staining of the treated skin by the test substance was observed in all animals during the observation period.
Any other information on results incl. tables
Toxicity symptoms
No symptoms of systemic toxicity were oberved in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal application of Pacified Reactive Black 31 resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin
- Executive summary:
The study was carried out in accordance with the OECD Guideline No. 404, "Acute Dermal Irritation / Corrosion" and the EEC Directive 92/69/EEC, B.4 "Acute Toxicity - Skin Irritation".
Three rabbits were exposed to 0.5 g of Pacified Reactive Black 31, applied onto shaved skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.
Exposure to Pacified Reactive Black 31 resulted in a very slight erythema in the treated skin area in one animal, which had resolved within 24 hours after expsoure. No skin irritation was observed in the other two animals.
Black staining of the treated skin by Pacified Reactive Black 31 was observed during the observatin period.
No signs of systmic toxicity were observed udring the study period.
Dermal application of Pacified Reactive Black 31 resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin.
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