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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2010-01-13 - 2010-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Spinel (Mg(AlO2)2)
- EC Number:
- 215-105-9
- EC Name:
- Spinel (Mg(AlO2)2)
- Cas Number:
- 1302-67-6
- IUPAC Name:
- 1302-67-6
- Reference substance name:
- magnesium dialuminium oxide
- IUPAC Name:
- magnesium dialuminium oxide
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: his G46, uvrb, rfa
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrb, pKM101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Plate-incorporation method: 50, 151, 500, 1510, 4990 µg/plate
Pre-incubation method: 319, 643, 1261, 2506, 5031 µg/plate - Vehicle / solvent:
- sterile water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: hisD6610, uvrB, pKM 101, rfa
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
1.1 First Experiment
1.1.1 Confirmation of the Criteria
The treatments for the sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory (historical data of the laboratory). All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.
1.1.2 Solubility and Toxicity
The test item was not sufficiently soluble in the accepted solvents for the Ames-test. Therefore, suspensions were prepared. The test item was autoclaved and suspended in deionised water.
No signs of toxicity towards the tested strains could be observed. The background lawn was visible and the number of revertant colonies was not reduced.
1.1.3 Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Therefore the test item is stated as not mutagenic under the test conditions.
To verify this result, a second experiment was performed using the pre-incubation method.
1.2 Second Experiment
1.2.1 Confirmation of the Criteria
The treatments for the sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls showed mutagenic effects with and without metabolic activation.
1.2.2 Solubility and Toxicity
The test item was not sufficiently soluble in the accepted solvents for the Ames-test. Therefore, suspensions were prepared. The test item was autoclaved and suspended in deionised water.
No signs of toxicity towards the tested strains could be observed. The background lawn was visible and the number of revertant colonies was not significantly reduced.
1.2.3 Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation was observed. No concentration-related increase over the tested range was found.
Therefore the test item is stated as not mutagenic under the test conditions.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item Spinel is not mutagenic under the conditions of the test. Applying read-across it can be concluded that Pleonaste is not mutagenic in the Bacterial Reverse Mutation Test. - Executive summary:
Justification for read-across:
Spinel type minerals all have a spinel crystal structure, no water solubility and high melting points. Their behaviour in water and biological systems is dominated by their insolubility and missing bioavailability. They constitute in general practically inert materials also regard to their content of heavy metals. Thus, they to not contribute to any ecological hazards. They are also not bioavailable in vivo, which was confirmed by solubility tests in surfactant and stomach/small intestine fluids. The Spinel type minerals are not skin irritating and not eye irritating in the conducted in vitro tests. In addition, there is no sensitizing concern for the Pleonaste metal constituents Fe and Mg.
Physico-chemical properties of Spinel and Pleonaste:
Spinel Pleonaste density (g/cm3) 3.55 3.82 melting-point (degree C) 2,135 > 1,650 water-solubility insoluble insoluble bioavailability in the digestive tract not bioavailable not bioavailable bioavailability in the lung not bioavailable not bioavailable
crystal structure spinel lattice spinel lattice The test item Spinel did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only).
Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased.
Therefore it can be stated, that under the test conditions, the test item Spinel is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strainsTA 97a, TA 98, TA 100, TA 102 and TA 1535.
Applying read-across it can be concluded that Pleonaste is not mutagenic in the Bacterial Reverse Mutation Test.
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