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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP)
Data source
Reference
- Reference Type:
- publication
- Title:
- Subchronic Oral Toxicity and Analytical Studies on Nickel Rutile Yellow and Chrome Rutile Yellow with Rats
- Author:
- Bomhard E et al.
- Year:
- 1 982
- Bibliographic source:
- Toxicol. Letters, 14, 189-194
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Levels of nickel and antimony in liver and kidneys, respectively, were measured after 1 and 2 months after exposure
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- C.I. Pigment Yellow 53
- IUPAC Name:
- C.I. Pigment Yellow 53
- Reference substance name:
- Nickel rutile yellow
- IUPAC Name:
- Nickel rutile yellow
- Details on test material:
- - Molecular formula: Ni Sb Ti O
- Analytical purity: technical grade
- Composition of test material, percentage of components: molarity based: Ti 0.88, Sb 0.05, Ni0.075; weight based: TiO2 80%, Sb2O5 15%, NiO 5%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: SPF-derived Wistar TNO W74
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 4-5 weeks
- Housing: macrolon cages
- Individual metabolism cages: no
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- reported as "standard conditions"
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Mixing appropriate amounts of powdered food with test substance - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 100, 1000, 10000 ppm in the diet (0.45, 4.5, 45, 450 mg/kg bw/day)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15 (control: 30). Additionally, 10 animals were used for analytical investigations (control: 20).
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Post-exposure period: no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule: weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
HAEMATOLOGY/CLINICAL CHEMISTRY/URINALYSIS: Yes
- Time schedule for collection of blood: after one month and at the end of the study
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5/sex/dosing group
- Parameters checked: RBC, reticulocytes, platelets, haemoglobin, haematocrit, total and differential WBC, MCV, ALP, GOT (AST), GPT (ALT), creatinine, urea, glucose, cholesterol, total plasma and urine proteins, urinalysis; thromboplastin time and glutamate dehydrogenase activities were measured after 3 months
OTHER: Liver and kidneys from 5 animals/sex/dose were examined for their nickel and antimony content after 1, 2 and 3 months. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes. Thyroid gland, thymus, heart, lung, liver, spleen, kidneys, adrenals, gonads were weighed. Liver, aorta, eyes, intestines, femur, brain, urinary bladder, pituitary, cervical lymph nodes, stomach, oesophagus, epididymides, pancreas, prostate, seminal vesicle, sternum (bone marrow), trachea, uterus, skeletal muscle (M. quadriceps with N. ischiadicus) from 5 males and 5 females of the control and top dose groups were investigated
ORGAN WEIGHT: Yes, the following organs were weighed during necropsy: thyroid, thymus, heart, lung, liver, spleen, kidneys, adrenals and gonads - Other examinations:
- After 1, 2 and 3 months, liver and kidneys from 5 animals per gender and dose group were analysed for their nickel and antimony contents by AAS. The detection limit for antimony was 5 ppb and for nickel 10 ppb.
- Statistics:
- The results of the body and organ weight determination as well as the haematological and clinical chemical data were compared using the U-test according to WiIcoxon (1947). A difference was considered to be significant at P<=0.05.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs or mortality was observed during the study period.
BODY WEIGHT AND WEIGHT GAIN
The test substance did not have any effect on body weight and weight gain.
FOOD CONSUMPTION
Food consumption of the treated animals was normal throughout the study period.
HAEMATOLOGY/CLINICAL CHEMISTRY/URINALYSIS
No treatment related effects were seen with regard to hematological, biochemical parameters or urinalysis.
ORGAN WEIGHTS
Normal organ weights were observed for thyroid, thymus, heart, lung, liver, spleen, kidneys, adrenals and gonads.
GROSS PATHOLOGY
No gross internal lesions were observed during necropsy.
HISTOPATHOLOGY: NON-NEOPLASTIC
No indications of treatment related findings were seen in any of the examined tissues.
OTHER FINDINGS
No antimony was detectable in liver and kidneys after 1 and 2 months at any dose. After three months of treatment with 10000 ppm of the test substance, antimony was detectable in liver (6 ppb) and kidney (5 ppb) of males slightly above the detection limit and in females at levels of 6 (liver) and 10 (kidney) ppb. Nickel concentrations could not be detected in liver or kidneys of the test animals.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 450 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The detected traces of antimony most likely originate from the acid-soluble impurities of the pigment (10 - 20 mg antimony/kg pigment, that is 5-10 µg/kg bw or 125-250 µg/kg organ weight at the highest dose) and therefore do not indicate bioavailability of the pigment itself. Neither the pigment itself nor the bioavailable traces of leachable metal ion impurities are considered to have toxicological significance even after extremely high oral exposure.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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