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Reaction mass of Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)Vinyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)]-, sodium and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[2-(sulfooxy)Ethanol]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt
EC number: 941-883-0 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 24 to September 25, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Maximisation test was available.
Test material
- Reference substance name:
- Reactive Black 031
- IUPAC Name:
- Reactive Black 031
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Weight at study initiation: 309-348 g
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on softwood granulate, in groups of 5 animals
- Diet: Altromin 3112 far guinea pigs and rabbits, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 ± 20 %
- Photoperiod: 12 hours cycle dark/light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- 50 % Freund's adiuvant
- Concentration / amount:
- 1 %, 0.1 ml
- Day(s)/duration:
- injection on day 1
- Adequacy of induction:
- other: concentration causing very slight to slight oedema and indurations
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 %, 0.5 ml
- Day(s)/duration:
- from day 8 to day 10
- Adequacy of induction:
- other: non irritant
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 %, 0.5 ml
- Day(s)/duration:
- 1 day, i.e. day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Determination of the primary non-irritant concentration: 6
Determination of the tolerance of intradermal injections: 3
Escort group: 5
Control group: 5
Treatment group: 10 - Details on study design:
- DETERMINATION OF THE PRIMARY NON-IRRITANT CONCENTRATION:
In a dermal occlusive test for primary skin irritation each of the following test concentrations was applied to the left flank of two Guinea pigs:
25 % in isotonic saline
5 % in isotonic saline
1 % in isotonic saline
The hair on the left flank of the animals was removed mechanically. 0.5 ml of the test substance preparation was applied to a 2 cm × 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema .
DETERMINING OF THE TOLERANCE OF INTRADERMAL INJECTIONS
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injectlon to 3 Guinea pigs. The injection sites were all within a dorsal area measuring 2 cm × 4 cm in the vicinity of the shoulder.
5 % in isotonic saline
1 % in isotonic saline
0.2 % in isotonic saline
MAIN STUDY
A1. INDUCTION EXPOSURE
- No. of exposures: 2 intradermal injections
- Exposure period: day 1
- Test groups: 10
- Control group: 5
- Site: dorsal area measuring 2 × 4 cm in the vicinity of the animals shoulder. The injection sites were left uncovered.
- Concentrations:
Site 1: 2 × 0.1 ml 50 % Freund's Adjuvant
Site 2: 2 × 0.1 ml 1 % solution of test substance in isotonic saline
Site 3: 2 × 0.1 ml 1 % solution of test substance in 50 % Freund's Adjuvant
A2. DERMAL INDUCTION TREATMENT
- No. of exposures: 1 patch application
- Exposure period: day 8
- Test groups: 10
- Control group: 5
- Site: dorsal area measuring 2 cm × 4 cm in the vicinity of the animals shoulder. Intradermal induction area.
- Frequency of applications: 1 application
- Duration:48 hours
- Concentrations:
Treatment group: 25 % (0.5 ml) test substance in isotonic saline
Control group: isotonic saline
B. CHALLENGE EXPOSURE
- No. of exposures: one application
- Day of challenge: 22
- Exposure period: 24 hours
- Test groups: 10
- Control group: 5
- Site: one area of approx. 5 cm × 5 cm an the left flank
- Concentrations: 25 % (0.5 ml) test substance in isotonic saline (treated and control group)
- Evaluation: 48 and 72 hours after challenge - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in isotonic saline
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- blue discolored
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 % in isotonic saline
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- dry, rough, skin scabbed, blue discolored
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs of irritation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs of irritation
Any other information on results incl. tables
Determination of the primary non-irritant concentration
No signs of irritation occurred after application of the different test concentrations, i.e. 25 %, 5 % and 1 % in isotonic saline.
Tolerance of intradermal injections
The intradermal injections with the 0.2 % preparations caused no oedema. After injection of the 1.0 % preparation very slight to slight oedema and indurations occurred. The application areas treated with the 5.0 % preparation showed slight to moderate oedema with indurations and encrustations. Evaluation of erythema was not possible due to blue discoloured skin. Based on this preliminary test, a 1 % preparation was selected for the intradermal injections in the main test.
Signs and bodyweight
Treated animals showed no clinical signs of intoxication throughout the study. Body weight gains of treated animals were not impaired.
Challenge treatment
24 and 48 hours after removal of the occlusive bandage 9 of 10 animals of the treated group showed very slight to severe erythema as well as very slight to slight oedema. In some cases the skin of the treated area was dry, rough and scabbed. Additionally, the treated area was discoloured blue.
No signs of irritation were observed 24 and 48 hours after removal of the occlusive bandage in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results in Guinea pig maximisation test, the substance is a skin sensitiser.
- Executive summary:
Method
Testing for sensitising properties of test material was performed in female Guinea pigs according to the Magnusson & Kligman method. Intradermal induction was performed using 1.0 % of test substance in isotonic saline as well as in 50 % Freund's adjuvant. Dermal induction and challenge treatment were carried out with 25 % of test item in isotonic saline.
Results
Positive response was seen in 9/10 animals upon observation at 48 and 72 hours after challenge in treated animas. Therefore, the substance is considered as skin sensitiser.
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