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
Here the results of two GLP studies and a publication, all using MMVF note Q fibres as a test substance, are used. The results are evaluated to be also representative for E-glas microfibre. It is assessed that E-glass microfibre is neither irritant to the eye nor to the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Although the studies used for eye and skin irritation evaluation were carried out using MMVF note Q fibres, these results are evaluated to be also representative for E-glass microfibre. These fibres have similar physical and chemical properties and any observed effect is due to mechanical irritiation.
Albino rabbits have been exposed to 0.5 g MMVF note Q fibres under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours and after 7 and 14 days or 2.5x2.5 cm of the test material under a semi-occlusive bandage for 4 hours and subsequently monitored at the intervals of 1, 24, 48, 72 hours and after 7 and 14 days. In both studies the mean score for erythema was 1, and mean score for oedema was 0. It is concluded that E-glass microfibre is not irritating to human skin.
Effects on the outer eye of occupational exposure to mineral wool fibres was investigated in mineral wool workers along with a matched non-exposed control group in a cross-sectional study (Stokholm et al, 1982). After 4 working days the workers showed a significantly higher frequency of eye symptoms, microepithelial defects on medial bulbar conjunctiva and neutrophil cell count in conjunctival fluid. The effects were reversible. The mechanism was explained as the same foreign body reaction as is seen for skin irritation. The foreign body reaction can be compared to the mechanical abrasive effect from sand particles. The fibres align along the surface of the eye and do not penetrate into the body. It is concluded that E-glass microfibre is not irritating to human eyes.
Justification for classification or non-classification
The studies used for eye and skin irritation evaluation were carried out using MMVF note Q fibres. The results are evaluated to be also representative for E-glass microfibre.
Mineral wool causes minor reversible mechanical skin irritation in rabbits. The mean score erythema was 1, and mean score for oedema was 0. It is evaluated that E-glass microfibre shall not be classified as skin irritant according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
Mineral wool causes reversible mechanical eye irritation in workers exposed to mineral wool fibres. This effect is not regarded as irritation in the meaning of Council Directive 67/548/EEC and Regulation (EC) 1272/2008. It is evaluated that E-glass microfibre shall not be classified as eye irritant according to Council Directive 67/548/EEC and Regulation (EC) 1272/2008.
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