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EC number: 234-808-1 | CAS number: 12034-57-0
- 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
- Study period:
- 2003-01-02 to 2003-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Niobium oxide
- EC Number:
- 234-808-1
- EC Name:
- Niobium oxide
- Cas Number:
- 12034-57-0
- Molecular formula:
- NbO
- IUPAC Name:
- niobium oxide
- Test material form:
- solid
- Details on test material:
- - Lot/batch No. of test material: SNB10OG200277M
- Expiration date of the lot/batch: 2003-12-31
- Purity: >99%
- Description: black, odourless powder
- Storage condition of test material: dry, room temperatue, closed container
Constituent 1
- Specific details on test material used for the study:
- - Treatment of test material prior to testing: The test item was suspended in dimethylsulfoxide prior to use after crushing with a pestle and mortar to a fine dust, because there is no other suitable solvent. The suspension was carefully mixed immediately before administration. The homogeneity was proved visually.
Method
- Target gene:
- Salmonella typhimurium TA1535, TA1537, TA 100, TA 98: Histidine locus
Escherichia coli WP2uvrA: Tryptophan locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Prof. Bruce N. Ames (University of California, Berkely, USA)
MEDIA USED
- Nutrient medium: 15 g Nutrient broth (SIFIN GmbH, D-13088 Berlin) per litre
- Selective Agar: minimal glucose agar plates
- Overlay Agar: 9 g agar agar (Merck, D-64293 Darmstadt), 5 g NaCl, 100 mL sterile 0.5 mM Histidine/Biotine (Merck, D-64293 Darmstadt) solution per litre
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: DSMZ (Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, 38124 Braunschweig, Germany)
MEDIA USED
- Nutrient medium: 15 g Nutrient broth (SIFIN GmbH, 13088 Berlin, Germany) per litre
- Selective Agar: minimal glucose agar plates
- Overlay Agar: 9 g agar agar (Merck, D-64293 Darmstadt), 5 g NaCl, 10 mL sterile Tryptophan solution (1 mg/ml; Merck, D-64293 Darmstadt) per litre.
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- TA 100 and the E. coli strain were tested in dose range finding study. A direct plate incorporation test was carried out, using concentrations of the test item of 5.0, 1.0, 0.5, 0.1, 0.05 and 0.01 mg/plate.
Based on the results the follwing five concentrations were chosen for the main experiment: 5.0, 1.0, 0.5, 0.1 and 0.05 mg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535 without S9, 5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without S9, 100 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without S9, 5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- E.coli WP2uvrA, without S9, 1.3 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains, with S9, S. tymphimurium: 5.0 µg/plate, E.coli: 50.0 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, Experiment I); pre-incubation (in suspension, Experiment II)
EXPERIMENTAL PERFORMANCE
- Experiment I:
The following were added to sterile tubes containing 2 ml of top agar: 0.1 ml of test item solution (or positive control or solvent) solution, 0.1 ml of bacteria culture, 0.5 ml of S9 mix (or 0.2 M phosphate buffer). The contents of each tube were mixed and added to a Petri dish containing minimal agar. Once the top agar had set, the dishes were inverted and incubated at 37 °C for 48 h.
- Experiment II:
The following were added to sterile tubes: 0.1 ml of test item solution (or positive control or solvent) solution, 0.1 ml of bacteria culture, 0.5 ml of S9 mix (or 0.2 M phosphate buffer). Each tube was fitted with a sterile cap and the contents were mixed followed by incubation at 37 °C for 20 min. Two ml of top agar were added to each tube and following mixing the contents were added to petri dishes containing minimal agar. When the top agar had set, the dishes were inverted and incubated at 37 °C for 48 h.
SCORING
Revertant colonies were scored manually at the end of the incubation period.
DURATION
- Pre-incubation period:(Experiment II): 20 min at 37 °C
- Exposure duration: 48 h at 37°C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Plate incorporation test with S. typhimurium TA 100 and E. coli WP2 uvrA
- Determination of spontaneous revertants and condition of the bacterial background lawn - Evaluation criteria:
- - Positive Result:
A Test is considered to be positive if the test item induces dose related increases in numbers of revertants scored in two separate experiments and these
increases are deemed to be of biological relevance. Reproducible increases at one experimental point may also be indicative of a positive response. For a biologically relevant response the number of revertants is expected to be at least the double of spontaneous reversion.
- Negative Result:
A test item producing neither a dose related and reproducible increase in the number of revertants nor a reproducible positive response at any experiment point is considered to be non-mutagenic in this test system.
- Results of Positive Controls:
The positive controls should markedly increase the number of revertant colonies in all bacterial strains with and without metabolic activation to demonstrate the effective performance of each assay. - Statistics:
- The results are presented as individual plate counts. In addition mean values and standard deviations are calculated for each strain and experimental point. As unequivocal results were obtained in both experiments a statistical evaluation was not deemed to be necessary.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA 1535 and TA 1537
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- For detailed results please refer to Table 1 in box "Any other information on results incl. tables".
Any other information on results incl. tables
Table 1: Summarized Results
Bacteria tester strain | Metabolic activation | Exp. | Mean numbers of revertants | Evaluation | |||||||
Controls | mg test item per plate | ||||||||||
UTC | VC | PC | 5.0 | 1.0 | 0.5 | 0.1 | 0.05 | ||||
Salmonella typhimurium | |||||||||||
TA1535 | no | 1st | 19.0 | 21.0 | 1269.3 | 18.3 | 19.0 | 19.0 | 20.7 | 19.0 | - |
no | 2nd | 18.0 | 18.3 | 1792.0 | 12.0 | 17.3 | 18.7 | 16.0 | 16.7 | - | |
yes | 1st | 25.0 | 27.0 | 282.7 | 22.3 | 22.0 | 22.7 | 21.3 | 24.3 | - | |
yes | 2nd | 18.7 | 21.0 | 309.3 | 21.0 | 19.0 | 21.7 | 19.7 | 19.7 | - | |
TA1537 | no | 1st | 8.7 | 11.7 | 2560.0 | 8.3 | 7.7 | 7.3 | 7.0 | 9.3 | - |
no | 2nd | 14.7 | 14.0 | 1600.0 | 13.3 | 13.0 | 12.7 | 11.0 | 10.7 | - | |
yes | 1st | 12.7 | 13.0 | 389.3 | 12.7 | 11.3 | 11.0 | 12.0 | 13.7 | - | |
yes | 2nd | 14.3 | 12.7 | 389.3 | 11.3 | 12.7 | 11.3 | 12.0 | 9.3 | - | |
TA 98 | no | 1st | 24.3 | 20.0 | 720.0 | 18.3 | 15.3 | 21.3 | 17.7 | 18.3 | - |
no | 2nd | 19.3 | 16.3 | 624.0 | 15.3 | 16.7 | 14.7 | 13.0 | 14.0 | - | |
yes | 1st | 25.7 | 24.7 | 3349.3 | 33.3 | 31.3 | 36.3 | 38.7 | 38.0 | - | |
yes | 2nd | 29.3 | 27.0 | 3109.3 | 30.7 | 30.3 | 27.3 | 30.3 | 31.7 | - | |
TA 100 | no | 1st | 201.3 | 20.0 | 1786.7 | 171.3 | 183.3 | 207.3 | 187.3 | 189.7 | - |
no | 2nd | 234.3 | 16.3 | 1445.3 | 189.7 | 188.0 | 183.0 | 190.0 | 206.0 | - | |
yes | 1st | 206.7 | 24.7 | 3642.7 | 198.7 | 168.0 | 204.0 | 195.3 | 190.0 | - | |
yes | 2nd | 221.0 | 27.0 | 3061.3 | 201.7 | 199.3 | 196.0 | 216.3 | 214.7 | - | |
Escherichia coli | |||||||||||
WP2uvrA | no | 1st | 27.3 | 23.3 | 282.7 | 282.7 | 26.7 | 26.3 | 25.7 | 23.7 | - |
no | 2nd | 27.7 | 28.0 | 378.7 | 378.7 | 29.0 | 28.7 | 32.7 | 29.0 | - | |
yes | 1st | 39.7 | 38.3 | 261.3 | 261.3 | 34.0 | 45.3 | 39.3 | 37.7 | - | |
yes | 2nd | 43.3 | 40.3 | 170.7 | 170.7 | 36.3 | 40.7 | 48.0 | 43.0 | - |
Abbreviations:
Exp.= independent experiment 1 or 2, 1stexperiment: plate incorporation method, 2ndexperiment: pre-incubation method
UTC = untreated control
VC = vehicle control
PC = positive control
- = none mutagenic effect
+ = mutagenic effect
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test item is not genotoxic in the bacterial reverse gene mutation assay in the presence and absence of mammalian metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria (EU method B.13/14), strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli strain (WP2uvrA) were exposed to Niobium(II) oxide (>99% purity) suspended in DMSO at concentrations of 5.0, 1.0, 0.5, 0.1 and 0.05 mg/plate in the presence and absence of mammalian metabolic activation. Niobium(II) oxide was tested up to the limit dose (5.0 mg/plate). The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable and satisfies the requirement for Test Guideline Directive 67/548/EEC, Annex V, B.13/14 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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