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Diss Factsheets
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EC number: 432-240-0 | CAS number: 12056-51-8
- 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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Jan to June 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP compliant study but study report available. The report contains limited experimental detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: Intratracheal instillation
- Principles of method if other than guideline:
- Research performed to quantify particle characteristics, perform quantitative analysis of the lung tissue samples to determine lung burden, examine biopersistance, and observe histopathological changes to evaluate inflammatory and fibrotic response.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- TOFIX-S
- IUPAC Name:
- TOFIX-S
- Reference substance name:
- Reference substance 001
- Test material form:
- solid: fibres
- Details on test material:
- - Name of test material (as cited in study report): Potassium titanium oxide
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:Particle (fibre)
- Analytical purity:No data
- Impurities (identity and concentrations):No data
- Composition of test material, percentage of components:No data
- Isomers composition:No data
- Purity test date:No data
- Lot/batch No.:No data
- Expiration date of the lot/batch:No data
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:Stable
- Storage condition of test material:No data
- Other:Particle dimensions: Diameter Geometric Mean Diameter 1.4um; Geometric Standard Deviation 1.5; Geometric Mean Length 6.2 um; Geometric Standard Deviation 1.8. Approximately 15% of fibres were found to be less than 0.8um in diameter but were shorter than 20um. No fibres longer than 20um were found.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 70 (nine week old) male Wistar rats were used.
The source of animals, diet, water, acclimatisation, weight and environmental conditions animals were maintained under was not documented.
Administration / exposure
- Route of administration:
- other: intratracheal instillation
- Vehicle:
- physiological saline
- Details on exposure:
- See report
- Doses:
- Single administration, 2 mg of TOFIX-S in 0.4ml of saline
- No. of animals per sex per dose:
- 35 treated with Tofix-S via intratracheal Instillation with the remainder kept as control animals.
- Control animals:
- yes
- Details on study design:
- See attached report
- Duration of observation period following administration: 6 months
- Frequency of observations and weighing:Clinical observations, daily; body weights, weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Organ weights and histopathology at 3 days, 1 week, 1 month, 3 months and 6 months post-dose.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: discriminating concentration
- Effect level:
- < 2 other: mg (total dose)
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- No effects of treatment reported
- Body weight:
- No effects of treatment reported
- Gross pathology:
- no details
- Other findings:
- Biological half life in the lungs is 2.2 months.
- Organ weights: No significant differences were found
- Histopathology: No significant differences were found
- Potential target organs: Lung
- Other observations: Lung burden of TOFIX-S was increased after treatment; Formation of 8-hydroxydeoxyguanosine, fibrosis related gene, TIMP-2 were not increased by treatment up to 6 months after dosing;
Applicant's summary and conclusion
- Conclusions:
- The substance is relatively harmless.
Tofix-S was predicted to have limited biological effect after a single intratracheal instillation. The biological half-life of TOFIX-S was determined to be 2.2 months. Measurements of indices for lung inflammation and fibrogenesis did not predict a fibrogenic response. No significant histopathological changes and no significant increase in the formation of 8-hydroxydeoxyguanosine (indicative of oxidative damage) was observed relative to the control. - Executive summary:
The biological effects of TOFIX-S in rats were investigated following a single intratracheal instillation in saline. Seventy male rats were divided into two groups of 35. One group was given a single intratracheal instillation of TOFIX-S in physiological saline and the other a single intratracheal instillation of physiological saline. Interim kills were carried out at 3 days, 1 week, 1 month, 3 months and 6 months. Histopathology, organ weights and indices of inflammation were investigated. No effects of TOFIX-S were reported. The lung burden of TOFIX-S was measured. The biological half-life of TOFIX-S was determined and estimated to be 2.2 months.
The acute toxicity of TOFIX-S via inhalation cannot be determined from this study since the route of administration is by intratracheal instillation. The study result should be used as supporting information.
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