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Diss Factsheets
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EC number: 952-967-1 | CAS number: -
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Sodium titanates are effectively the sodium salts of the unstable titanic acid (titanium hydroxide). Titanium hydroxide is hard to isolate without rapid hydrolysis to titanium dioxide and sodium chloride. It is therefore proposed to base environmental and health assessment on these two hydrolysis products. There has been extensive research on similar substances in the ‘titanate’ grouping and these all exhibit similar behaviour in that under acid biological conditions (eg if ingested) or if dispersed in water, there is dissociation of the ions and subsequent hydrolysis / oxidation. Read-across justification for the use of TiO2 data is available in section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Fischer 344 male rats were exposed either with whole-body or nose-only inhalation for 6 hrs. Control animals were exposed to fresh air only. After the exposue period of 6 hrs animals were immediately sacrificed by overdose of phenobarbital. The body weights were recorded, the lungs were collected and the wet lung weights measured. The right lung was used for determining the amounts of TiO2, while the left lung was used for histopathological examination
- GLP compliance:
- not specified
- Remarks:
- All procedures and animal handling were done according to the guidelines described in the Japanese Guide for the Care and Use of Laboratory Animals as approved by the Animal Care and Use Committee University of Occupational and Environmental Health Japan.
- Limit test:
- no
Test material
- Reference substance name:
- Titanium dioxide
- EC Number:
- 236-675-5
- EC Name:
- Titanium dioxide
- Cas Number:
- 51745-87-0
- Molecular formula:
- O2Ti
- IUPAC Name:
- Titanium dioxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Nano-scale TiO2 (MT-150AW, TAYCA, Japan)
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Fifteen Fischer 344 male rats (11 weeks old) were purchased from Charles River Laboratories International, Inc. (Japan). The animals were kept in the Laboratory Animal Research Center of the University of Occupational and Environmental Health for 1 week with access to free-feeding of commercial diet and water. All procedures and animal handling were done according to the guidelines described in the Japanese Guide for the Care and Use of Laboratory Animals as approved by the Animal Care and Use Committee, University of Occupational and Environmental Health, Japan.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- other: whole body and nose only
- Vehicle:
- air
- Details on inhalation exposure:
- Rats were divided into three groups of five rats each for whole-body inhalation and for nose-only inhalation of TiO2 for 6 h, and for controls exposed to fresh air only.
Titanium dioxide powder was suspended in ultra-pure water for nanoparticle generation. The TiO2 concentration in the chambers was measured every hour by weighing the filtered particles. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The TiO2 in each right lung were digested with lung tissues with HNO3 H2SO4, (NH4)2SO4 and H2O2 by microwave digestion under a high-temperature and highpressure condition for 30 min and the amounts of Ti ion in the digested solution were determined by ICP
- Duration of exposure:
- 6 h
- Concentrations:
- The average mass concentration of the TiO2 aerosol was 4.01 ± 1.11 mg/m3 in the nose-only chamber and 4.10 ± 1.07 mg/m3 in the whole-body chamber, respectively.
- No. of animals per sex per dose:
- 5 animals per group. Only male rats were used
- Control animals:
- yes
- Details on study design:
- All the rats were sacrificed by overdose of pentobarbital immediately after 6 h inhalation. The wet lung weights of each rat were measured, and each right lung was used for determining the amounts of TiO2, while each left lung was used for histopathological examination
- Statistics:
- Analysis of variance (ANOVA) and Dunnett’s test were applied where appropriate to determine individual differences using a computer statistical package (SPSS, SPSS Inc., Chicago, IL, USA).
The amounts of TiO2 in the lungs after the inhalation were 42.6 ± 3.5 μg in the whole-body inhalation group and 46.0 ± 7.7 μg in the nose-only inhalation group. There was no statistical difference between the two groups.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LC50
- Remarks on result:
- not measured/tested
- Remarks:
- No mortality was observed during the exposure time and histopathological examination showed no Infiltrations of inflammatory cells in the alveolar space and interstitium, fibrosis or tumorgenesis in any of the treatment groups or in the control group. Macrophages engulfed pigment-like components in both whole-body and nose-only exposure were the only observation in treatment groups.
- Mortality:
- None observed
- Body weight:
- Before the exposure, the body weights were almost the same in the three groups. After the exposure, that in the nose-only inhalation group was less, but the difference was not significant.
- Gross pathology:
- Infiltrations of inflammatory cells in the alveolar space and interstitium, fibrosis and tumorigenesis were not observed in any of the three groups. Macrophages engulfed pigment-like components in both whole-body and nose-only exposure
Applicant's summary and conclusion
- Conclusions:
- A whole-body inhalation study and a nose-only inhalation study of the same TiO2 nanoparticles in almost the same experimental conditions was carried out and compared the particle deposition and histopathological changes in the lung. The two inhalation studies yielded almost the same results.
This study exposed rate for 6 hours at concentrations of 4 mg/m³ via whole body and nose only. The aim of this study was to investigate differences for the two exposure conditions. No mortality occurred and histopathological examination showed no Infiltrations of inflammatory cells in the alveolar space and interstitium, fibrosis or tumorgenesis in any of the animals. Macrophages engulfed pigment-like components in both whole-body and nose-only exposure were the only observation in treatment groups.
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