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Diss Factsheets
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EC number: 221-394-2 | CAS number: 3085-30-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro mutagenicity assessment of aluminium oxide nanomaterials using the Salmonella/microsome assay
- Author:
- Balasubramanyam A, Sailaja N, Mahboob M, Rahman MF, Hussain SM, Grover P.
- Year:
- 2 010
- Bibliographic source:
- Toxicol In Vitro.Sep;24(6):1871-6 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Remarks:
- Information on GLP is not reported. Quality of the report implies that GLP conditions were met.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Aluminium oxide
- EC Number:
- 215-691-6
- EC Name:
- Aluminium oxide
- IUPAC Name:
- aluminium oxide
Constituent 1
- Specific details on test material used for the study:
- purity > 90%
particle size: 50-200 um
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 100, TA 1535, TA 98, TA 97a, TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from male rat liver (no details)
- Test concentrations with justification for top dose:
- 20, 40, 75, 150, 300, 600, 1250 and 2500 ug/plate
Based on the presence of precipitate above 2500 ug/plate - Vehicle / solvent:
- vehicle:DMSO/ H2O (1/1)
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO/H2O
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: aminoanthacene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: pre-incubation
- Cell density at seeding (if applicable): 1E09 cells/mL
DURATION
- Preincubation period: 30 min
- Exposure duration: 48 hours at 37 °C
NUMBER OF REPLICATIONS: 6
DETERMINATION OF CYTOTOXICITY
- Method: reduction of bacterial background lawn, reduction of revertant colonies - Rationale for test conditions:
- standard according to OECD 471
- Evaluation criteria:
- significant increase of number of revertant colonies compared to controls
- Statistics:
- NA
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA98, TA97a, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Ames test
- Executive summary:
In a test according to OECD 471 Salmonella typhimurium strains TA 100, TA1535, TA98, TA97a and TA102 were exposed to aluminium oxide with and without metabolic activations. No increase in the number of revertants was observed in any of the strains tested. Therefore it is concluded that the substance is not mutagenic.
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