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EC number: 269-047-4 | CAS number: 68186-85-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77377.
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991-06-24 to 1991-09-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented (GLP, but no control)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- yes
- Remarks:
- Deviations: The analysis of Ni and Sb content in the organs of the test animals was performed in a laboratory without quality assurance unit. Therefore, the report was not audited by QAU; the stability of the test substance has not been proven
Test material
- Reference substance name:
- C.I. Pigment yellow 53
- IUPAC Name:
- C.I. Pigment yellow 53
- Reference substance name:
- Antimony nickel titanium oxide yellow
- EC Number:
- 232-353-3
- EC Name:
- Antimony nickel titanium oxide yellow
- Cas Number:
- 8007-18-9
- IUPAC Name:
- 8007-18-9
- Reference substance name:
- Lichtgelb 8G
- IUPAC Name:
- Lichtgelb 8G
- Details on test material:
- - Physical state: yellow powder
- Composition of test material (percentage of components, weight based): TiO2 76.8%, Sb2O5 13.6%, NiO 5% , SiO2 2.4%, Pb 31 ppm, As 16 ppm, other heavy metals < 5 ppm; Ni soluble in 0.1 N HCl 46 ppm
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: Wistar/Chbb:THOM
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 230 - 232 g (the average weight of the additional set of animals 304 g ± 1.7 g)
- Housing: Single in Makrolon/wire cages (type MD III of Becker, Castrop-Rauxel, Germany)
- Diet: KLIBA rat/mouse/hamster laboratory diet 24-343-4 10 mm pellets; Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: during exposure withdrawn
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: aerodynamic exposure apparatus (INA 60, volume V 90 L, BASF AG)
- Method of fixing animals in test chamber: exposure tubes; animal snouts projecting into the inhalation chamber
- Rate of air: Supply air (L/h): compressed air 1500, blast air 4500; Exhaust air (L/h): 5400
- System of generating particulates/aerosols: dust generator
- Temperature, humidity: 23.3-23.6 °C , 50.6-54.0 %
- Method of particle size determination: Gravimetrical determination
TEST ATMOSPHERE
- Samples taken from breathing zone: yes - Duration and frequency of treatment / exposure:
- 5 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
60 mg/m3
- No. of animals per sex per dose / concentration:
- 50 (divided into 5 groups with differing post-exposure periods)
- Control animals:
- other: During analyses of livers and kidneys of the first test groups the need occurred to analyse kidneys of untreated animals (blank values), therefore another set of animals was delivered age-matched to the test animals of test group 1 at sacrifice.
- Details on study design:
- Post-exposure period: 0, 3, 10, 31, 60 days
- Details on dosing and sampling:
- Monitoring of the inhalation atmosphere
Sampling: apparatus and conditions
- Vacuum compressed air pump (Millipore)
- Sampling equipment with probe (Millipore)
- Internal diameter: 7 mm for test groups 1 to 5
- Filter: MN 85/90 Bf (d = 4.7 cm)
- Sampling velocity: 1.25 m/s
- Sampling amount: 45 L
- Sampling site: immediately adjacent to the animals' noses
- Sampling frequency: as a rule, one sample per concentration group about hourly. - Statistics:
- No statistical evaluation was performed because no concurrent control was available.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- LUNG: Immediate post-exposure concentrations of Ni and Sb were 79 and 202 µg/lung, respectively (corresponding to 2 mg of pigment/lung). The concentrations declined during the post-exposure period, following first order kinetics; the clearance half-life was 50 days.
LIVER: Mean Sb concentration (quantification limit 0.2 ng/g of liver) in unexposed animals was 1.1 ng/g; immediate post-exposure and day 3 post-exposure concentrations were about 4-fold higher in exposed animals. During further observations the concentrations were similar to unexposed animals (1.3 ng/g on day 10). Mean Ni-concentration was in the same range in exposed and unexposed animals (however, below the quantification limit of 10 ng/g; outliers not considered).
KIDNEYS: Mean Sb concentration in unexposed animals was below the detection limit (1 ng/g), in exposed animals it was above the detection limit but below the quantification limit (3 ng/g), only the day 3 post exposure group reached a value of 5.6 ng/g (2 to 3-fold increase compared with other observation days). Mean Ni concentration was below the detection limit (1 ng/g) in unexposed animals and above detection limit but below quantification limit (25 ng/g) in exposed animals, except on day 3 post-exposure, when 94 ng/g were determined (10-fold more than in other exposure groups. Presumably due to contamination of the sample.
Any other information on results incl. tables
The exposure level was set to a ten fold higher level than the limit level for inert dusts set at that time by the German MAK Commission and to ensure a sufficient measureable Ni-deposition in the lung. Though a control group was not studied through the course of the experiment, the results obtained appear internally consistent and interpretable in relation to toxicity for the following reasons:
- mortality: no deaths were observed during the exposure and post exposure periods
- clinical examination: no clinical signs were observed which were different from normal
- body weight: weight gains were not affected compared with historical controls.
With respect to the observed levels of Ni and Sb in liver, kidneys and lung the non-bioavailability of the pigment has been clearly demonstrated. Both metals were present in liver and kidneys in the range of the limit of quantitation or below, with the exception of a clear Ni peak in the kidneys on day 3 of the post-exposure period. This peak can hardly be explained physiologically and a contamination with Ni during the processing steps by an unknown Ni source cannot be excluded. In conclusion, this study demonstrates the non-bioavailability of Ni and Sb after inhalation of the test substance.
Applicant's summary and conclusion
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