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Diss Factsheets
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EC number: 226-102-7 | CAS number: 5280-66-0 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15865:4.
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
- EC Number:
- 231-494-8
- EC Name:
- Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
- Cas Number:
- 7585-41-3
- Molecular formula:
- C18H13ClN2O6S.Ba
- IUPAC Name:
- barium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- - Substance type: red powder
- Physical state: solid
- Name of test material (as cited in study report): 4812 C-93/1068
- Purity: > 95%
- Expiry date: > 5 years (1998)
- Lot/batch No.: 93/1068
- Storage condition of test material: room temperature
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Substance type: red powder
- Physical state: solid
- Name of test material (as cited in study report): 4812 C-93/1068
- Purity: > 95%
- Expiry date: > 5 years (1998)
- Lot/batch No.: 93/1068
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent (UK)
- Age at study initiation:
- Weight at study initiation: malles weighed 237 - 264g, and the females 200 - 207g
- Fasting period before study: not applicable
- Housing: groups of five by sex in
- Diet and water (e.g. ad libitum): With the exception of the exposure period, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23°C
- Humidity (%): 46 - 61%.
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 August 1993 To: 31 August 1993
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 1.4 µm
- Geometric standard deviation (GSD):
- 0.34
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose-only apparatus
- Exposure chamber volume: 30 Litres
- Method of holding animals in test chamber: tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber '0' ring
- Source and rate of air: Compressed air was supplied by means of a Gast oil free compressor and was passed through a water trap and respiratory quality filters which removed particulate material above 0.005 μm before it was introduced to the dust feed. Flow rate was 8 litres/min providing 36 air changes per hour.
- Method of conditioning air: Compressed air was supplied by means of a Gast oil free compressor and was passed through a water trap and respiratory quality filters which removed particulate material above 0.005 μm before it was introduced to the dust feed.
- System of generating aerosols: Wright Dust Feed' mechanism located at the top of the exposure chamber and driven by a variable speed motor. The dust feed was connected to a metered compressed air supply.
- Method of particle size determination: Cascade Impactor (10, 6, 3.5, 1.6, 0.9 and 0.5 μm cut-off points)
- Treatment of exhaust air: Extract from the exposure chamber passed through a 'scrubber' trap and was connected with a high efficiency filter to a metered exhaust system.
- Temperature, humidity, pressure in air chamber: negative pressure, humidity 41 - 50%, temperature 20 - 23°C
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric method, employed glass fibre filters (Gelman type A/E 25 mm) placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals' breathing zone. Exposure chamber air was drawn through the filter at a measured rate using a vacuum pump for a suitable time period.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- Particle size distribution: 83.1% < 4 μm; 100% < 10 μm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.4 μm / 0.34
The tested concentration was the highest attainable concentration. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 4.76 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 4.76 mg/L air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: range between 3.24 and 6.34 mg/L; 1/10 rats died.
- Mortality:
- One male was found dead approximately 186 minutes after the start of the exposure.
- Clinical signs:
- other: During exposure animals commonly showed wet fur, laboured, decreased or increased respiratory rate and red staining of the fur from the test material. On removal from the chamber and one hour after completion of exposure additional signs of toxicity noted
- Body weight:
- A marginal reduction in bodyweight gain was noted in several animals during the first week of the study. Expected bodyweight development was observed during week two.
- Gross pathology:
- The male that died during the study showed swollen and abnormally dark lungs and pink contents in the small intestine at necropsy. No abnormalities were detected in surviving animals at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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