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EC number: 470-870-8 | CAS number: 690271-93-3
- 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: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 to 25 April 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised test guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3465 (90-Day Inhalation Toxicity)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Terracess TF
- IUPAC Name:
- Terracess TF
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Terracess TF-S
- Appearance: white powder
- Purity: 99.6%
- Lot/batch No.: 4D90
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)IGS BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: The mass median aerodynamic equivalent diameter of the aerosols ranged from 2.5 to 2.9 μm.
Geometric standard deviations ranged from 1.3 to 1.6. - Details on inhalation exposure:
- Mass median aerodynamic diameter: 2.5 to 2.9 microns
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- During each exposure, the atmospheric concentration of the test substance was determined by gravimetric analysis at approximately hourly intervals in the test chambers.
- Duration of treatment / exposure:
- Test duration: 90 days
- Frequency of treatment:
- Duration of exposure per day: 6 hours
Dosing regime: 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.0, 10, and 50 mg/m³
Basis:
analytical conc.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Four groups of 20 male and 15 female rats each were exposed to aerosols of Terracess TF-S dust at analytically determined concentrations of 2.0, 10, or 50 mg/m³. A similarly comprised control group of rats was simultaneously exposed to air only.
After the conclusion of the exposure phase there were 2 recovery periods of approximately 3 and 15 weeks. At the 3-week recovery, 5 male rats per group were sacrificed and given anatomic pathology examinations; the remaining male and female rats were sacrificed 15 weeks after exposure and also given anatomic pathology examinations.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: during and after exposure + detailed observations once a week
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION: not applicable (not a drinking water study)
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to assignment to groups and at the end of the exposure period
- Dose groups that were examined all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the exposure period
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: 10 out of 20 per group
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of the exposure period
- Animals fasted: Yes
- How many animals: 10 out of 20 per group
.
URINALYSIS: Yes
- Time schedule for collection of urine: at the end of the exposure period
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: near the end of the exposure period
- Dose groups that were examined: all
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Digestive System; Cardiovascular System; Musculoskeletal System; Hematopoietic System; Reproductive System; Urinary System;
Endocrine System; Respiratory System; Nervous System;
HISTOPATHOLOGY: Respiratory tract tissues were examined from all rats following the 90-day exposure. These respiratory tract tissues included the nose (4 cross sections), larynx and pharynx (2 cross sections), trachea (1 cross section) and lungs (cross sections of the right apical and caudal lobes; longitudinal section of the left lobe). For those rats selected for lung titanium analysis (5 males/exposure concentration/time point), only the left lung lobe was examined microscopically. In addition to non-polarized light, polarized light was used to examine all respiratory tissue in an effort to maximize identification of the test material within tissue sections. - Other examinations:
- skin, and eyes (including optic nerve)
- Statistics:
- Significance was judged at p < 0.05. Separate analyses were performed on the data collected for each sex.
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:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Description (incidence and severity):
- not applicable (not a drinking water study)
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A small increase in lung weight parameters was observed in high-concentration male rats after the 90-day exposure period.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- One high-concentration male was noted to have mottled dark discoloration of the lungs at necropsy while one high-concentration female had diffuse white foci in the lungs, correlating with the microscopic aggregation of particulate-laden macrophages
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical observations:
There were no test-substance related adverse effects on mortality, body weights, clinical signs, neurobehaviour parameters or food consumption during the study. Clinical pathology evaluations showed no effects in haematology, coagulation, serum chemistry, or urine parameters as a result of exposure to Terracess TF-S dust.
Laboratory findings:
At each sacrifice period, sections of the lungs of 4 or 5 male rats per group were collected for titanium content to determine lung deposition and clearance of the test material. Based on this information, the clearance half times for Terracess TF-S were estimated to be in the order of 6 to 9 months for the 50mg/m3 group and 2 to 3 months for the 10 and 2 mg/m3 groups, respectively. These values are in the range of other insoluble, low toxicity dusts
like titanium dioxide.
Organ weight analyses at the end of the exposure period showed a statistically significant increase in lung-to-body weight ratios in the high-level males compared to controls. These differences were no longer present in male rats examined after 3- or 15-week recovery periods.
Effects in organs:
Histologic evaluation showed an exposure-related uptake of aerosol particulates by the resident pulmonary alveolar macrophages within the lung. There was no evidence of increased macrophage numbers, inflammation, or fibrosis. Male rats allowed to recover for 3 and 15 weeks showed migration of pulmonary macrophages into aggregates and gradual clearance of test material. The microscopic findings were consistent with exposure to a non-pathogenic, nuisance dust.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.01 mg/L air
- Basis for effect level:
- other: exposure duration: 6 hours/day
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the no-effect level (NOAEL) for rats exposed to the test substance for approximately 90-days was 10 mg/cubic metre based on reversible lung weight effects in male rats at the highest exposure level.
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