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
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
It is assessed that E-glass microfibre is not taken up into the body by ingestion or dermal contact. No systemic exposure is expected.
Inhaled fibres are cleared from the lungs and swallowed, and are disintegrated in the lung and the gastrointestinal fluids.
E-glass microfibre has been shown to induce lung tumours (carcinoma and adenoma) at high concentrations in long-term inhalation toxicity studies, probably due to the higher biopersistence of fibers longer than 20 µm. The mechanism of which E-glass microfibre induces lung tumours is not fully disclosed but overload of cellular clearance mechanisms have been suggested.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
The most likely exposure route for E-glass microfibre is assessed to be inhalation (see section 4.5 of this registration, where granulometry of E-glass microfibre is presented and inhalation is evaluated to be a relevant exposure route). In long-term inhalation toxicity studies E-glass microfibre was observed to undergo congruent dissolution. E-glass microfibre has been shown to have low solubility at neutral pH and to disintegrate in an acidic environment. Inhaled E-glass microfibre dissolves in the rat lung and is subjected to breakage through the acidic attack of macrophages. Removal of fibres deposited on surfaces within the respiratory system involves dissolution and disintegration and phagocytosis by alveolar macrophages for shorter fibres.
E-glass microfibre has been shown to induce lung tumours (carcinoma and adenoma) at high concentrations in long-term inhalation studies, probably due to the higher biopersistence of fibers longer than 20 µm. The mechanism by which E-glass microfibre induces lung tumours is not fully elucidated but overload of cellular clearance mechanisms has been suggested (Searl et al., 1999).
It is evaluated due to the inert nature as well as low absorption potential, very low water solubility and low possibility of crossing biological barriers that systemic exposure to E-glass microfibre leading to toxic reactions is very unlikely.
Discussion on bioaccumulation potential result:
The most likely exposure route for E-glass microfibre is assessed to be inhalation, based on the following facts: 1) E-glass granulometry presented in section 4.5 suggested that E-glass microfibre is inhalable, 2) E-glass is inorganic, chemically inert and has very low absorption potential through skin and through ingestion.
In long-term inhalation toxicity studies E-glass microfibre was observed to undergo congruent dissolution. E-glass microfibre has been shown to have low solubility at neutral pH and to disintegrate in an acidic environment. Inhaled E-glass microfibre dissolves in the rat lung and is subjected to breakage through the acidic attack of macrophages. Removal of fibres deposited on surfaces within the respiratory system involves dissolution and disintegration and phagocytosis by alveolar macrophages for shorter fibres.
Finally, due to the inert nature and the low possibility of crossing biological barriers, systemic exposure to E-glass microfibre is very unlikely. Based on the data, it is evaluated that E-glass microfibre has low bioaccumulation potential.
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