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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Based on the justification of the three main components of the test substance:
Aluminium compounds show NOECs and EC10s ranged from 0.088 to 2.3 mg Al/L and 0.078 to 5.19 mg Al/L, respectively. The CSA of CaO indicates no need to investigate further effects on aquatic organisms. Magnesium oxide (MgO) is exempted from registration according to EC 1907/2006 Annex V Section 10.
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, data and justification based on these main components were taken into account by read across following a structural analogue approach.
Aluminium-compounds:
Long Term Fish Toxicity Literature Review: Four long-term reliable chronic toxicity studies for aluminium compounds to two species of fish (Pimephales promelas and Salveninus fontinalis) were identified as acceptable from the published literature. NOECs and EC10s ranged from 0.088 to 2.3 mg Al/L and 0.078 to 5.19 mg Al/L, respectively.
The Al BLM developed using gill accumulation data from S. salar was applied to the chronic Pimephales promelas data (Oregon State University Aquatic Toxicology Laboratory 2010; Figure 7.1.1.1.2.-1, see attachment). Application of the model to new data requires development of a critical accumulation value appropriate for the exposure duration and toxicity endpoint. In addition, calibration of the model to these data benefited from two other changes in parameter values. First, since the chronic endpoints for this species and in these test conditions were at much higher aluminium concentrations and saturation of NOM binding sites included in the model was beginning to occur, resulting in a somewhat reduced predicted effect of NOM compared with the observed effect. The binding site density for NOM was increased by two fold to provide adequate binding sites at these high Al concentrations. In addition, although the effect of hardness on observed aluminium toxicity was consistent in acute and chronic exposures, the predicted effect of hardness could be improved by a small change in the binding strength of Ca (i.e. the log K for binding at the biotic ligand was increased from 4.2 to 4.8.
After application of the Al BLM, the variability in the response curve between effects of aluminium on the biotic ligand was reduced compared with response curve based on total aluminium (Figure 7.1.1.1.2.-2, see attachment). Values for critical accumulation were estimated directly from the predicted response curve on the biotic ligand to establish the CA10, or the critical accumulation level that results in a chronic effect of 10% (in this case a reduction in growth).
Figure 7.1.1.1.2.-3 (see attachment) provides an evaluation of the ability of the long-term fish BLM to predict EC10 values. In this case, most of the EC10 values are predicted within 2-fold of the reported EC10 values, and all of the predicted EC10 values are within 4-fold of the reported values.
Calcium-compounds:
For CaO there is no need to consider testing in accordance with column 2 of REACH Annex VII, since CSA indicates no need to investigate further effects on aquatic organisms.
Magnesium oxide:
Magnesium oxide (MgO) is exempted from registration according to EC 1907/2006 Annex V Section 10.
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