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EC number: 412-960-1 | CAS number: 148878-21-1 PROCION BRILLIANT ORANGE H-EXL; S156745
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate
- EC Number:
- 412-960-1
- EC Name:
- Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate
- Cas Number:
- 148878-21-1
- Molecular formula:
- Hill formula: C54H31Cl2N14Na8O26S8 CAS formula: C54H38Cl2N14O26S8.xNa
- IUPAC Name:
- 2-[(4-chloro-6-{[(3-{[4-chloro-6-({6-[2-(1,5-disulfonaphthalen-2-yl)diazen-1-yl]-5-hydroxy-1,7-disulfonaphthalen-2-yl}amino)-1,3,5-triazin-2-yl]amino}phenyl)methyl](methyl)amino}-1,3,5-triazin-2-yl)amino]-6-[2-(1,5-disulfonaphthalen-2-yl)diazen-1-yl]-5-hydroxynaphthalene-1,7-disulfonic acid octasodium hydride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Tes item name in report: S156745
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield farms, UK limited
- Age at study initiation: young and adult
- Weight at study initiation: 2974-3895 g
- Housing: The rabbits were housed individually in aluminium sheet cages (65.2 cm × 68.9 cm × 45.7 cm)
- Acclimation period: 6 d prior to test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: The test substance was moistened with bi-distilled water before application.
- Amount / concentration applied:
- 0.5 g /animal
- Duration of treatment / exposure:
- 4 h
- Observation period:
- upto 4 d
- Number of animals:
- Three females
- Details on study design:
- TEST SITE
- Area of exposure: left flank of the test animals
- Type of wrap if used: treated area covered with piece of surgical quaze which was secured by two crossed strips of surgical tape. This was covered by piece of impermeable rubber sheet wrapped around the trunk of the animal and secured with adhesive impermeable polyethylene tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed with absorbant cotton swabs soaked in warm water to remove the residual amount of test susbtance.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS: 4 d
(indicate if minutes, hours or days)
SCORING SYSTEM:
- Method of calculation: The Draize scale
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
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
Any other information on results incl. tables
Pathological data:
Animal number | Histopathological finding | ||||||||
Hyperkeratosis | Parakeratosis/surface debris | Acanthosis | Inflamatory cell infiltration | oedema | Hair folicle loss | Subepithelial fibrosis | |||
4 | C | 0 | 0 | 0 | 1 F | 0 | 0 | 0 | DHP |
4 | T | 0 | 0 | 1 D | 2 M-F | 0 | 0 | 0 | DHP |
5 | C | 0 | 0 | 1 D | 1 M-F | 0 | 0 | 0 | SHP |
5 | T | 0 | 0 | 1 D | 2 M-F | 0 | 0 | 0 | SHP |
6 | C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | SHP |
6 | T | 0 | 0 | 1 D | 0 | 0 | 0 | 0 | SHP |
C= control, T=test, DHP=dense hair pattern, SHP=sparse hair pattern, F= Focal, M-F=Multifocal, D=Diffuse 0=No reaction, 1=Minimal reaction, 2=Slight reaction, 3=Moderate reaction, 4=Marked reaction, 5=Sever reaction
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the substance was not irritating to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation potential of the substance according to a method similar to OECD Guideline 404, in compliance with GLP. The primary skin irritation potential of the test substance was investigated by topical application of 0.5 g to 2.5 cm x 2.5 cm of intact dorsal skin of three young New Zealand White rabbits. The duration of the treatment was 4 h. The scoring of skin reactions was performed at 1, 24, 48, 72 and 96 h after removal of the dressing. The scores of each animal at 24, 48 and 72 h were used in calculating the respective mean values for each type of lesion. The test substance caused red staining of the treated skin and obscured the assessment of erythema. Mean edema scores were calculated for each animal by adding together the oedema score at 1, 2 and 3 d readings and dividing the total by three which is 0.0. Mean erythema score could not be calculated, since the staining obscured the assessment of erythema. There were no other visible signs of irritation seen any animal. Histopathological examination revealed a slight inflammatory reaction in two of the test sites. Under the study conditions, the substance was not irritating to rabbit skin (Robinson, 1994).
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