Registration Dossier
Registration Dossier
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EC number: 266-340-9 | CAS number: 66402-68-4 This category encompasses the various chemical substances manufactured in the production of ceramics. For purposes of this category, a ceramic is defined as a crystalline or partially crystalline, inorganic, non-metallic, usually opaque substance consisting principally of combinations of inorganic oxides of aluminum, calcium, chromium, iron, magnesium, silicon, titanium, or zirconium which conventionally is formed first by fusion or sintering at very high temperatures, then by cooling, generally resulting in a rigid, brittle monophase or multiphase structure. (Those ceramics which are produced by heating inorganic glass, thereby changing its physical structure from amorphous to crystalline but not its chemical identity are not included in this definition.) This category consists of chemical substances other than by-products or impurities which are formed during the production of various ceramics and concurrently incorporated into a ceramic mixture. Its composition may contain any one or a combination of these substances. Trace amounts of oxides and other substances may be present. The following representative elements are principally present as oxides but may also be present as borides, carbides, chlorides, fluorides, nitrides, silicides, or sulfides in multiple oxidation states, or in more complex compounds.@Aluminum@Lithium@Barium@Magnesium@Beryllium@Manganese@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Carbon@Sodium@Cerium@Thorium@Cesium@Tin@Chromium@Titanium@Cobalt@Uranium@Copper@Yttrium@Hafnium@Zinc@Iron@Zirconium
Toxicity to birds
Administrative data
Link to relevant study record(s)
Description of key information
Based on the justification of the three main components, it can be concluded:
The potential for massive aluminium, powders or aluminium oxide to be consumed by birds is extremely negligible.
As calcium oxide is transformed to calcium and hydroxyl ions and does not occur in its original form in living organisms, the levels of calcium and hydroxyl ions in organisms will be systemically regulated.
Magnesium oxide (MgO) is exempted from registration according to EC 1907/2006 Annex V Section 10.
Therefore, the potential for secondary poisoning is expected to be low for the test substance.
Key value for chemical safety assessment
Additional information
There are no studies available for “Reaction product of thermal process between 1000°C and 2000°C of mainly aluminium oxide and calcium oxide based raw materials with at least CaO+Al2O3+MgO >80% , in which aluminium oxide, magnesium oxide and calcium oxide in varying amounts are combined in various proportions into a multiphase crystalline matrix”. As this substance is an UVCB substance with aluminium oxide (AL2O3), calcium oxide (CaO) and magnesium oxide (MgO) as main constituents, justification based on these main components were taken into account by read across following a structural analogue approach.
Aluminium-compounds:
Aluminium (Al) impairment in birds and mammals is mainly related to its disruptive effect on calcium homeostasis as well as phosphorus metabolism. This adverse effect leads to muscle weakness and decreased growth rates (Scheuhammer 1987). This metal also induces defective eggshell formation and intrauterine bleeding in Al-contaminated pied flycatchers (Ficedula hypoleuca; Nyholm, 1981). Scheuhammer (1991) examined the accumulation of aluminium in different species of ducklings dwelling in an acidified lake in,. The species of ducks chosen for study have significantly different feeding habits. Young black and ring-necked ducks feed mainly on surface insects in near-shore vegetation; goldeneye and hooded mergansers are pursuit divers that prey on large, mobile invertebrates, although goldeneye take more benthic material, and hooded mergansers probably take some fish and amphibians as well; common mergansers are almost exclusively fish-eaters. Tissue metal concentrations accumulated by ducklings during their first few months of life indicate that dietary exposure of ducklings to toxicologically relevant levels Al is unlikely to occur in acidified environments. Kidney-A1concentrations ranged from undetectable (< 0.01 µg/g) to about 5 µg/g.
Avian toxicity data are used in the assessment of secondary poisoning risks for the aquatic and terrestrial food chains. The available evidence shows the absence of aluminium biomagnification across trophic levels both in aquatic and terrestrial food chains. The existing information suggests not only that aluminium does not biomagnify, but rather that it tends to exhibit biodilution at higher levels of the food chain. The potential for massive aluminium, powders or aluminium oxide to be consumed by birds is extremely negligible. Therefore the need for additional testing for secondary poisoning can be waived. More detailed information can be found in the attached document (White paper on waiving for secondary poisoning for Al & Fe compounds final report 25-01-2010. pdf, see attachment).
Calcium-compounds:
Information on this endpoint is required for the assessment of the risks for secondary poisoning. Secondary poisoning is concerned with toxic effects in the higher members of the food chain, either living in the aquatic or terrestrial environment, which result from ingestion of organisms from lower trophic levels that contain accumulated substances. In the environment, calcium oxide is transformed to calcium and hydroxyl ions and does not occur in its original form in living organisms. Therefore it is concluded that birds or other higher members of the food chain will not be exposed to calcium oxide as such and therefore this endpoint is considered not to be relevant. Furthermore, the levels of calcium and hydroxyl ions in organisms will be systemically regulated.
Magnesium oxide:
Magnesium oxide (MgO) is exempted from registration according to EC 1907/2006 Annex V Section 10.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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