Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-468-4 | CAS number: 12005-50-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- 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:
- 1302-67-6
- Cas Number:
- 1302-67-6
- IUPAC Name:
- 1302-67-6
- Reference substance name:
- Spinel (Mg(AlO2)2)
- EC Number:
- 215-105-9
- EC Name:
- Spinel (Mg(AlO2)2)
- IUPAC Name:
- 215-105-9
- Reference substance name:
- magnesium dialuminium oxide
- IUPAC Name:
- magnesium dialuminium oxide
Constituent 1
Constituent 2
Constituent 3
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. First Experiment
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.
1.2 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.
1.3 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.
2 Second Experiment
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.
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.
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.
Justification for read-across: Bonite is an inorganic substance used for refractory materials. Like Spinel it is produced under high temperature conditions and used as refractory material. Aluminium is firmly bound in the Bonite lattice (like Spinel) such that it does not have a relevant solubility which is a precondition for bioavailability. This was confirmed by solubility tests in physiological media (lung surfactant and digestive tract). Due to the similar physico-chemical properties of Spinel and Bonite read-across can be applied:
Spinel Bonite
density: 3.55 3.38
melting-point: 2,135 °C 1,905°C
water-solubility: insoluble insoluble
bioavailability in the digestive tract: not bioavailable not bioavailable
bioavailability in the lung: not bioavailable not bioavailable
It can be therefore stated that Bonite is not mutagenic in the Bacterial Reverse Mutation Test. - Executive summary:
The test item 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, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
Justification for read-across: Bonite is an inorganic substance used for refractory materials. Like Spinel it is produced under high temperature conditions and used as refractory material. Aluminium is firmly bound in the Bonite lattice (like Spinel) such that it does not have a relevant solubility which is a precondition for bioavailability. This was confirmed by solubility tests in physiological media (lung surfactant and digestive tract). Due to the similar physico-chemical properties of Spinel and Bonite read-across can be applied:
Spinel Bonite
density: 3.55 3.38
melting-point: 2,135 °C 1,905°C
water-solubility: insoluble insoluble
bioavailability in the digestive tract: not bioavailable not bioavailable
bioavailability in the lung: not bioavailable not bioavailable
It can be therefore stated that Bonite is not mutagenic in the Bacterial Reverse Mutation Test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.