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
Description of key information
E-glass microfibre is assessed to possess no toxic properties after repeated oral or dermal exposure.
E-glass microfibre is able to induce an inflammatory response in the lungs after inhalation exposure.The potential to induce an inflammatory response in lungs of healthy male Wistar rats following repeated inhalation exposure is documented in a study of repeated exposure for 3 months, followed by recovery periods of 1, 7, or 14 weeks, according to EC guideline ECB/TM16 (97) rev. 1, 1999. This observation is supported by a study of short-term repeated exposure for 7 hours to a fibre concentration of 1000 WHO fibres/ml air. The inflammatory response exhibits a pattern of progressively increasing level, with repeated exposure of 7 hours daily for 1 to 14 days (Searl et al 1999).
The LOAEC for induction of inflammatory response in the lungs of rats exposed repeatedly for 3 months was 15 WHO fibres/ml air (Bellman et al 2003).
Based on the data for repeated dose toxicity for exposure by inhalation, E-glass microfibre should be classified as holding specific target organ toxicity with repeated exposure Cat. 2 (H373) as it is able to induce an irreversible inflammatory response and fibrosis in the lungs.
Key value for chemical safety assessment
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- LOAEC
- 15
- Study duration:
- subchronic
- Species:
- rat
Additional information
Two studies on sub-chronic repeated exposure of male rats to inhalation of E-glass microfibre (104E) fibres (Endpoint Study 7.5.2.001: 1000 WHO fibres/ml air, 7 hours/day for 1, 3, 8 or 14 days; and Endpoint Study 7.5.2.002: 15, 50, or 150 fibres/ml air, 6 hours/day, 5 days/week for 3 months) document that the inhalation of E-glass microfibre induces an inflammatory response in the lungs, characterised by increased numbers of cells and granulocytes (predominantly polymorphnuclear cells) in fluid from bronchoalveolar lavage, increased levels of protein in the fluid from bronchoalveolar lavage, and increased numbers of proliferating cells in the lung parenchyma. As E-glass microfibre is chemically non-reactive, but is characterised physically to have relatively small fibre diameters and long mean fibre lengths and by being rather biopersistent with half-life times of 7 to 20 months in vivo, it is likely that the lung irritation/inflammation is induced mechanically or as a result of a foreign body reaction.
The LOAEC for induction of inflammatory response in the lungs of rats exposed repeatedly for 3 months was 15 WHO fibres/ml air (Bellman et al 2003).
Based on the data for repeated dose toxicity for inhalation exposure E-glass microfibre should be classified as holding specific target organ toxicity with repeated exposure, as it induces inflammation and fibrosis in the lungs.
Testing of repeated dose oral and dermal toxicity is waived as E-glass microfibre is inorganic, with physicochemical properties giving a low potential for absorption through the gastrointestinal tract and the skin. E-glass microfibre is soluble at the acid pH of the GI tract. Furthermore, oral and dermal exposures are not a significant exposure routes for E-glass microfibre (Adaptation to Annex IX, 8.6.2, and to Annex XI, 3). It is evaluated that systemic toxicity is unlikely after oral or dermal exposure to E-glass microfibre. Thus, E-glass microfibre is assessed not to possess toxic properties by repeated oral or dermal exposure.
Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: lung
Justification for classification or non-classification
E-glass microfibre belongs to the group of Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18% by weight (Index No 650-016-00-2). According to Commission Regulation (EC) No. 790/2009 (amending to EC regulation No. 1272/2008) Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18% by weight is classified as Carc. 2.
The physicochemical properties of E-glass microfibre suggest a low potential to cross biological membranes and consequently a low potential for absorption through the gastrointestinal tract and the skin. Studies on the biopersistence of E-glass microfibre indicate that accumulation of fibres occur with repeated inhalation exposure (See endpoint 7.12). Studies in endpoint 7.5 on repeated exposure by inhalation show that E-glass microfibre is able to induce inflammation and fibrosis in the lung, with a LOAEC of 15 WHO fibres/ml air (Bellman et al 2003).
In conclusion E-glass microfibre is classified Carc. Cat. 2; R49 (may cause cancer by inhalation) according to DSD-DPD. According to GHS it is classified as Carc 1B, H350i.
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