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EC number: 273-761-1 | CAS number: 69012-64-2 Amorphous silicon dioxide particles from the volatilization and vaporization of furnace feed materials in the manufacture of ferrosilicon and silicon.
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro transformation study in mammalian cells
- Remarks:
- Type of genotoxicity: genome mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.21 (In Vitro Mammalian Cell Transformation Test)
- Principles of method if other than guideline:
- Evaluation of cytotoxic and cell transforming effects of various crystalline (quartz, cristobalite) and amorphous forms of silica (biogenic, synthetic) in Syrian hamster embryo cells was performed.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell transformation assay
- Species / strain / cell type:
- mammalian cell line, other: Syrian hamster embryo cells
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 3, 8, 25 and 30 microg/cm2 (estimated on the basis of figures in study report)
- Vehicle / solvent:
- sterile tridistilled water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- no
- Positive control substance:
- other: 2158
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 h
- Exposure duration: 7 days
- Expression time (cells in growth medium): -
- Selection time (if incubation with a selection agent): -
- Fixation time (start of exposure up to fixation or harvest of cells): 7 days
DETERMINATION OF CYTOTOXICITY
- Method: Inhibition of cell growth. - Evaluation criteria:
- The criteria decribed by DiPaolo (Journal Natl Cancer Inst, 42, 867-876, 1969) and Pienta et al. (Short term tests for Chemical carcinogens, ed. H.F. Stick and R.H.C. San, Springer-Verlag, NY, p. 323-337, 1981) was used to define the colony as morphologically transformed
- Statistics:
- The relation between the transformation induced by a sample and the treatment concentrations was indicated by the significance of the correlation coefficient (r). No further information on statistical methods was given.
- Species / strain:
- other: Syrian hamster ovarian cells
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not examined
- Additional information on results:
- Comparison to diacemateous earth and crystalline silica was made. Hydrophilic pyrogenic silica (Aerosil® OX50) was neither cytotoxic nor transforming whereas some quartz and cristobalite samples and 3 differant diatomaceous earths induced cytotoxicity and morphological colony transformation in a dose-dependent manner. Surface properties (distribution of silanol groups and trace amounts of iron) appeared to be important in the induction of cytotoxicity.
- Remarks on result:
- other: strain/cell type: Syrian hamster ovarian cells
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Hydrophilic pyrogenic silica (Aerosil® OX50) was neither cytotoxic nor transforming. - Executive summary:
Elias et al. (2000) evaluated cytotoxic and cell transforming effects of various crystalline (quartz, cristobalite) and amorphous forms of silica (biogenic, synthetic) in Syrian hamster embryo cells. Hydrophilic pyrogenic silica (Aerosil® OX50) was neither cytotoxic nor transforming.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for selection of genetic toxicity endpoint
Evaluation of cytotoxic and cell transforming effects of various crystalline (quartz, cristobalite) and amorphous forms of silica (biogenic, synthetic) in Syrian hamster embryo cells was performed.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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