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EC number: 269-052-1 | CAS number: 68186-90-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77310.
- 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

Endpoint summary
Administrative data
Description of key information
ORAL
The NOAEL of >= 500 mg/kg bw/day (highest dose) was chosen from the oral 90-day key study (Bomhard et al., 1982).
INHALATION
The NOAEC of >= 60 mg/m3 (highest concentration) with a clearance half-life of 50 days in the lungs was taken from the 5-day inhalation key study (BASF AG, 33I0110/91008, 1994).
DERMAL
Assessment: dermal pathway not relevant due to lack of bioavailability.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Levels of chromium and antimony in liver and kidneys, respectively, were measured after 1 and 2 months
- Principles of method if other than guideline:
- Method: T26-16 (comparable to OECD guideline 408)
- GLP compliance:
- not specified
- Limit test:
- no
- 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" - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Mixing appropriate amounts of powdered food with the test substance - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
- Dose / conc.:
- 0 mg/kg diet
- Remarks:
- 0 mg/kg bw/day
- Dose / conc.:
- 10 mg/kg diet
- Remarks:
- 0.5 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg diet
- Remarks:
- 5 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg diet
- Remarks:
- 50 mg/kg bw/day
- Dose / conc.:
- 10 000 mg/kg diet
- Remarks:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- 15 (control: 30). 10 animals were used for analytical investigations (control: 20).
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Post-exposure period: no
- Observations and examinations performed and frequency:
- The animals were observed daily, food consumption and body weight were determined once a week. Haematological, clinical and biochemical investigations (RBC, reticulocytes, platelets, haemoglobin, haematocrit, total and differential WBC, MCV, ALP, GOT, GPT, creatinine, urea, glucose, cholesterol, total plasma and urine proteins, urinalysis) were conducted using recommended methods after one month and at the end of the study on 5 male and 5 female rats of each group. In addition, thromboplastin time and glutamate dehydrogenase activity were measured after 3 months.
- Sacrifice and pathology:
- All animals, killed at the end of treatment by exsanguination under ether anaesthesia, were subjected to detailed macroscopic examination. Thyroid gland, thymus, heart, lung, liver, spleen, kidneys, adrenals, gonads were weighed and 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 histopathologically examined. Paraffin slices were stained with haematoxylin and eosin. Additional kidney slices were stained by PAS and cryostat slices of liver with Oil Red O.
- Other examinations:
- After 1, 2 and 3 months liver and kidneys from 5 animals per gender and dose group analysed for their chromium and antimony contents by AAS. The detection limit for antimony was 5 ppb, chromium 2 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.
- 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
- Endocrine findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- No substance related effects on mortality, clinical signs, body weight/body weight gain, hematology, clinical chemistry, urinalysis, organ weights, gross pathology and histopathology were observed.
Food consumption was similar in all groups. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- haematology
- mortality
- urinalysis
- Key result
- Critical effects observed:
- no
Reference
CHEMICAL ANALYSIS
Antimony
In males and females the Sb concentrations in liver and kidney were below the detection limit at doses up to 1000 ppm. In the high dose groups the Sb levels slightly increased with exposure duration and reached max. 27 ppb in the liver (3 months) of males (range 15-40 ppb) and 17 ppb in females (kidney 14 ppb in males and 15 ppb in females).
Chromium
No measurable effect on chromium content of liver and kidney at any dose level and exposure duration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- HYPOTHESIS FOR THE ANALOGUE APPROACH
The substance belongs to the group of inorganic pigments with a rutile lattice in which titanium ions are partially replaced by other metal ions (antimony, nickel, chrome). The solubility of the target and source substance in water is very low. Bioavailability is regarded as negligible for both, target and source substance.
For further information, please refer to the Read across justification attached in IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 60 mg/m³ air
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Key result
- Critical effects observed:
- no
Reference
CONTENT OF Ni AND Sb in:
LIVER: Mean Sb concentration (quantification limit 0.2 ng/g) in unexposed animals was 1.1 ng/g; directly post-exposure and on day 3-post-exposure the concentration was about 4-fold higher in exposed animals, and during later observation the concentration was 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 (2-3-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 94 ng/g were determined (10-fold more than in other exposure groups. Authors comment: presumably due to contamination of the sample). LUNG: Directly post-exposure the mean Ni and Sb concentration was 79 and 202 µg/lung , respectively (corresponding to 2 mg of pigment/lung). The concentration declined during the post-exposure period, following first order kinetics; the clearance half-life was 50 days.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 60 mg/m³
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ORAL
For the oral exposure pathway a valid subchronic study was performed in rats.
In a subchronic study performed similar to OECD guideline 408, male and female Wistar rats were treated with 0.5, 5, 50 and 500 mg/kg bw/d for 90 d (Bomhard et al., 1982). No substance related effects on mortality, clinical signs, body weight, hematology, clinical chemistry, organ weights, gross pathology and histopathology were observed. There were no indications for bioavailability.
INHALATION
For the inhalative exposure pathway a valid subacute study was performed in rats only with an analogous substance, the nickel rutile. In a GLP-compliant bioavailability study, male Wistar rats were exposed for 5 d to 60 mg/m3 of the test substance; the observation period was 0, 3, 10, 31 and 60 d (BASF AG, 33I0110/91008, 1994). No effects on mortality, clinical signs, body weights and body weight gains were found. Clearance half time was approximately 50 days in the lung. The study was not able to demonstrate bioavailability after inhalation of the test substance.
DERMAL
No leaching of metal ions in artificial sweat solution was detected in a leaching study (see chapter 7.9.3). Therefore, the dermal exposure pathway is considered as not relevant.
CONCLUSIONS
The study data on oral and inhalation exposure reveal no treatment related adverse effects in any study. The investigation of the dermal pathway was not considered relevant due to the lack of bioavailability.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance does not need to be classified and labelled for repeated dose toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.
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