Registration Dossier
Registration Dossier
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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
There is no evidence of genotoxic or mutagenic potential of E-glass microfibre. In vitro studies have shown that E-glass microfibre is able to induce production of TNF-alpha by lung macrophages, but is not directly cytotoxic to alveolar epithelial cells, as indicated by a lack of effect in an in vitro epithelial cell detachment assay (Searl et al. 1999).
E-glass microfibre is inorganic. Its physicochemical properties suggest a low potential to cross biological membranes. Further, E-glass microfibre is chemically inert and does not leach any components, even after 12 months in the lung tissue (Searl et al. 1999). Biopersistence studies indicate that cellular resorption is the major route of removal of the highly biopersistent fibres in the lungs.
Based on the combined data from biopersistence studies, in vitro studies for cytotoxicity, and the ability to induce TNF-alpha production in lung macrophages, it is hypothesized that the tumorigenic potential of E-glass microfibre is connected to the chronic inflammation, most likely due to mechanical irritation or foreign body effects in the lung parenchyma and chronic inflammation.
As such, traditional in vitro assays for genotoxicity using bacteria or mammalian cell lines would not be appropriate, as it would not lead to a clarification of the mechanisms behind the carcinogenicity observed in the long-term studies.
Short description of key information:
There is no evidence of genotoxic or mutagenic potential of E-glass microfibre. In vitro studies have shown that E-glass microfibre is able to induce production of TNF-alpha by lung macrophages, but is not directly cytotoxic to alveolar epithelial cells, as indicated by a lack of effect in an in vitro epithelial cell detachment assay (Searl et al. 1999).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
E-glass microfibre is not genotoxic and is not classified for its genotoxicity.
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