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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, sufficiently documented and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Pulmonary chemokine and mutagenic responses in rats after subchronic inhalation of amorphous and crystalline silica.
- Author:
- Johnston, C.J. et al.
- Year:
- 2 000
- Bibliographic source:
- Toxicological Sciences 56, 405-413
Materials and methods
- Principles of method if other than guideline:
- Ex vivo (isolation of cells from treated animals) rat HPRT mutation assay with alveolar epithelial cells after 13 weeks inhalation exposure.
- GLP compliance:
- not specified
- Type of assay:
- endogenous gene animal assay
Test material
- Reference substance name:
- Cristobalite
- EC Number:
- 238-455-4
- EC Name:
- Cristobalite
- Cas Number:
- 14464-46-1
- IUPAC Name:
- 14464-46-1
- Details on test material:
- - Name of test material (as cited in study report): Cristobalite, crystalline silica
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- filtered air
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: compartmentalized 300-liters horizontal laminar flow chambers
- System of generating particulates/aerosols: a screw-feed mechanism in combination with a Venturi-type dust feeder. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/day, 5 days/week for 13 weeks
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3 ± 1 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- rat alveolar type-II cells
- Details of tissue and slide preparation:
- METHOD OF ANALYSIS:
Selection for mutation in the HPRT gene in cells isolated from treated animals. Isolated cells were seeded in flasks. After removal of non-adherent cells, cell cultures were fed with selection medium containing 6-thioguanine (40 µM); cultures were refed every other day with 6-TG-containing medium. After 14 - 21 days in culture the cells were fixed and immunostained with an antibody to cytokeratins 8, 18 and 19 and 6-TG-resistant cytokeratin staining colonies of greater than 50 cells counted. - Statistics:
- Analysis of variance. Differenced from the control group were determined using Dunnett's test. Statistical significance was considered at p < 0.05.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Mutation frequencies in the air control group were 7.6 ± 3.4 mutants/106 epithelial cells. Exposure to 3 mg/m3 crystalline silica resulted in HPRT mutation frequencies which were 4.3 -fold greater than the air control group, immediately after 13 weeks of exposure.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
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