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EC number: 266-046-0 | CAS number: 65997-17-3 This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
- 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 vitro
Administrative data
- Endpoint:
- genetic toxicity in vitro
- Remarks:
- Type of genotoxicity: other: Cytotoxicity and production of cytokines (Tumor Necrosis Factor-alpha (TNF-alpha))
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1997 – May 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. No guideline for the study was identified, but the method and results are described scientifically correct.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Tumour Necrosis Factor-Alpha (TNF-alpha) is a pleiotropic cytokine involved in inflammatory processes, which is toxic to some cell types and is suspected to be involved in the mechanisms leading to development of hyperplasia and tumours as sequelae to chronic inflammation. The in vitro assay involves testing of the potential of E-glass microfibre (Glass-fibre code 104E) to induce expression of TNF-alpha in lung macrophages as analyzed by a quantitative assay for cytotoxicity of TNF-alpha towards cultures of the L929-cell line, which is sensitive to TNF-alpha.
- GLP compliance:
- no
- Type of assay:
- other: In vitro study for production of Tumor Necrosis Factor-alpha (TNF-alpha)
Test material
- Reference substance name:
- E-glass microfibre
- IUPAC Name:
- E-glass microfibre
- Details on test material:
- - Name of test material (as cited in study report): Special purpose glass microfibre code 104E (abbreviated 104E)
- Produced and provided by: Manville Insulation, Mountain Technical Centre, Schuller International Inc. Littleton, Colorado, USA.
- Substance type: Man-made vitreous fibre
- Physical state: Solid, respirable fibre material (dust)
- Composition of test material, percentage of components: See Table 1.
- Fibre geometric dimensions (length, diameter and surface area, mean values): See Table 2
- Lot/batch No.: NA.
- Stability under test conditions: Stable
- Preparation of test samples: Test material provided in a bale. Respirable fibres were created by chopping in a Manesty rotary chopper, followed by milling in a Retsch Pin mill (Type ZM1) fitted with a 1 mm mesh. Samples of respirable fibres were weighed and suspended.
Constituent 1
Method
- Target gene:
- Expression of TNF-alpha by alveolar macrophages
Species / strainopen allclose all
- Species / strain / cell type:
- primary culture, other: Alveolar macrophages from rat, obtained by bronchoalveolar lavage
- Details on mammalian cell type (if applicable):
- - Type and identity of media: F-10 medium containing 0.2% Bovine serum albumin
- Primary culture
- cell concentration: 1*10^6 cells per well - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- mammalian cell line, other: L929 cell line
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM medium containing 5% fetal calf serum and 1 µg/ml actinomycin D. The cell line was kept in 96 well plates during the test.
- Properly maintained: No data
- Periodically checked for Mycoplasma contamination: No data
- Periodically checked for karyotype stability: No data
- Periodically "cleansed" against high spontaneous background: No data - Additional strain / cell type characteristics:
- other: TNF-alpha is toxic to the L929 cell line.
- Metabolic activation:
- not applicable
- Test concentrations with justification for top dose:
- 8.2 * 10^6 fibres (L > 5 µm) added to each well of a 24-well culture plate (volume of medium not mentioned).
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Test fibres were added suspended in an aqueous medium (not specified), and mixed with the F-10 cell medium.
- Justification for choice of solvent/vehicle: Not specified
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Recombinant human TNF-alpha was used for establishing a standard curve
- Positive control substance:
- other: 10 other fibre types were tested in the assay concomitantly.
- Details on test system and experimental conditions:
- Alveolar macrophages were harvested from rat lungs by bronchoalveolar lavage and cultured in F-10 medium containing 0.2% bovine serum albumin (BSA) at a cell concentration of 10^6 cells per well. To each well an aliquot of 8.2*10^6 fibres (Length > 5 µm) were added in an aqueous suspension. After 24 hours the supernatants were harvested, centrifuged to remove cells and fibres and stored at -70°C untill analysis. Serial dilutions of macrophage supernatants were made and added to cultures of the L929-cell line, which is sensitive to TNF-alpha. After one day of incubation the surviving L292-cells were stained using crystal violet and the staining intensity was quantified at 540 nm using a microplate reader. Each dilution of macrophage supernatant was analysed in triplicate, and for creation of a standard curve dilutions of recombinant human TNF-alpha was used. The results were expressed in international units (IU) per 10^6 macrophages. The complete experiment was repeated three times to obtain the data presented in the results section.
Results and discussion
Test results
- Species / strain:
- primary culture, other: Macrophages from rat lung
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Supernatant from fibre-treated macrophage cultures added to cultures of L929 cells
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- E-glass microfibre (Glass fibre code 104E) has an intermediate activity in relation to production of TNF-alpha in lung macrophages. See results in Table 2 below.
- Remarks on result:
- other: other: Production of TNF-alpha by rat lung macrophages
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2. TNF-alpha production by alveolar macrophages exposed in vitro to equal fibre numbers. Table contains means with estimated standard errors in italics |
||
Fibre type |
TNF-alpha Units per 106cells |
|
|
Mean |
Standard error |
No fibre |
37 |
10 |
104E |
71 |
19 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
The E-glass microfibre has an activity intermediate between the most active fibres- silicon carbide fibres and asbestos fibres, and the relatively inactive man-made vitreous fibres (MMVF's) and refractory ceramic fibres (RCF's). In conclusion, E-glass microfibre holds the potential to induce the production of the cytokine TNF-alpha by lung macrophages. - Executive summary:
The potential of E-glass microfibre to induce expression of TNF-alpha in lung macrophages was tested in vitro. Tumour Necrosis Factor-Alpha (TNF-alpha) is a cytokine which is toxic to some cell types, e.g. the L929 cell line used in this study, and is suspected to be involved in the mechanisms leading to development of hyperplasia and tumours in connection to chronic inflammation.
E-glass microfibre has an intermediate activity in relation to induce TNF-alpha production in lung macrophages. In conclusion E-glass microfibre holds the potential to induce the production of the cytokine TNF-alpha by lung macrophages.
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