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EC number: 275-735-5 | CAS number: 71630-92-7 Substance obtained by burning the husk removed from the rice paddy. Contains silica as well as the elements aluminum, calcium, carbon, chromium, copper, indium, iron, lead, magnesium, manganese, molybdenum, phosphorus, silver, sodium, tin, and zinc.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Characterization and toxicological behavior of synthetic amorphous hydrophobic silica
- Author:
- Lewinson, J. et al.
- Year:
- 1 994
- Bibliographic source:
- Regul Toxicol Pharmacol. 20(1 Pt 1):37-57
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- not specified
- Remarks:
- GLP study according to the authors. No further details on testing laboratory given.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Silane, dichlorodimethyl-, reaction products with silica
- EC Number:
- 271-893-4
- EC Name:
- Silane, dichlorodimethyl-, reaction products with silica
- Cas Number:
- 68611-44-9
- IUPAC Name:
- 271-893-4
- Details on test material:
- - Name of test material (as cited in study report): Aerosil r 972 (Fumed Hydrophobic Silica, FHS)
- Analytical purity: >99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for Breeding of Laboratory Animals, TNO, Zeist, The Netherlands
- Weight at study initiation: 182 g (males), 141 g (females)
- Housing: groups of five animals to a cage
- Diet (e.g. ad libitum): stock diet for rats (TNO) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1
- Humidity (%): 50-60
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel exposure chamber
- Exposure chamber volume: 1.5 m³
- Rate of air: 0.97 m³/h
- System of generating particulates/aerosols: The test material, a fluffy powder, was continuously dispersed in air by means of a brush-type dosing apparatus (Buerstendosierer Type III/A) with the maximum attainable concentration of the test material in the atmosphere.
- Method of particle size determination: Particle size determination was carried out in a sample taken from the test atmosphere in the chamber using a cascade impactor. The Netherlands Energy Research Foundation has determined a volume diameter of fumed hydrophobic silica aggregates in ethanol by means of a light scattering method (Swithenbank and Taylor, 1979. Size distribution measurement for near-monodisperse particles and sprays, Department of Chemical Engineering and Fuel Technology, University of Sheffield, England. Report No. HIC 315). Fromthe volume mean diemater (VMD) the mass median diameter can be calculated by multiplying the VMD by the density.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The results of the particle size distribution determination in a sample of the aerosol showed that the aerodynamic diameter of about 56% of the particles was smaller than 5 µm
- MMAD (Mass median aerodynamic diameter): 2.9 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The actual concentration was determined gravimetrically by passing a measured quantity of the test atmosphere through a glass fiber filter (Type SM 13400, Sartorius). Samples were taken at 60, 130, and 170 min after starting the exposure.
- Duration of exposure:
- 4 h
- Concentrations:
- 477 mg/m³
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were examined for clinical signs daily. Body weights were recorded prior to exposure and at Days 1, 2, 4, 7, and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.477 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the exposure period or during the subsequent observation period of 14 days.
- Clinical signs:
- other: During the 4-h exposure period with the maximum attainable concentration of test material in air (477 mg/m³) the rats were somewhat restless and drooping eyelids were observed.
- Body weight:
- The body weight decreased during the first 2 days and increased in a normal way thereafter.
- Gross pathology:
- At autopsy no abnormalities were found in gross pathology.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of the acute inhalation toxicity study indicate that fumed hydrophobic amorphous silica is virtually acutely nontoxic at the maximum attainable aerosol concentration.
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