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EC number: 234-809-7 | CAS number: 12034-59-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No data is available for Niobium dioxide (target substance). Thus, available data from Niobium oxide and Niobium pentachloride (source substances) are used to assess in a read-across approach the mutagenicity potential of Niobium dioxide. In a bacterial reverse gene mutation assay the source substance Niobium oxide was tested negative in S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli (WP2uvrA). In addition, the second source substance Niobium pentachloride was tested negative in an in vitro HPRT test according to OECD 476 and in an in vitro Comet assay.
Link to relevant study records
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- other: Human Jurkat T-lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >65 % at 0.5 mM and higher in comparison to untreated controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not examined
- Conclusions:
- Under the experimental conditions reported, the test item Niobium pentachloride solution is considered to be non-mutagenic.
- Executive summary:
In an in vitro Comet assay, human Jurkat T-lymphocyte cells cultured in vitro were exposed to Niobium pentachloride solution at concentrations of 0.05, 0.1, 0.5, 1.0 and 5 mM in the absence of mammalian metabolic activation. For assessment of cytotoxicity apoptosis and cell viability were measured. Niobium pentachloride solution induced >50% caspase-9 positive cells at 0.5 mM concentration or higher (apoptosis) and a reduction of viable cells to <33% at 0.5 mM and higher (cell viability). Niobium pentachloride solution showed no effect on cell proliferation at the concentrations tested. No significant increase of DNA damage, measured by using an index of DNA damage (IDD, average tail length of 50 cells) were observed. Therefore, niobium pentachloride solution is considered to be not genotoxic in the Comet assay.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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 see Table 1 in box "Any other information on results".
- 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 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 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.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A biologically relevant growth inhibition (reduction of relative growth below 70%) was observed after the treatment with the test item in experiment I and II without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: The pH-value detected with the test item was within the physiological range (pH 7.0 ± 0.4).
- Effects of osmolality: not examined
- Precipitation: Precipitation of the test item was noted in experiment I without metabolic activation at concentrations of 0.5 mM and higher and with metabolic activation at concentrations of 0.25 mM and higher. In experiment II precipitation was detected at concentrations of 0.2 mM and higher with metabolic activation.
RANGE-FINDING/SCREENING STUDIES:
A solubility test was performed with different solvents and vehicles. Based on the results of the solubility test EtOH was used as solvent. After pre-dissolving the test item in EtOH (100 mM) a dilution series was prepared in EtOH. First a 9fold volume of phosphate buffer was used adding it to each concentration. After noticing that in the pre-experiment without metabolic activation the buffer reacts with the cells the phosphate buffer was replaced for the main experiments by Aqua ad injectabilia. So the 9fold volume of Aqua ad injectabilia was added to each concentration. After an initial reaction of approx. 10 minutes, this test item solution was added to cell culture medium (MEM without serum) at a ratio of 1 :10, resulting in 1% EtOH and 9% Aqua ad injectabilia in the final treatment medium. The pH-value detected with the test item was within the physiological range (pH 7.0 ± 0.4). The solvent used is a composition of well-established solvents and is compatible with the survival of the cells and the activity of the S9 mix. The toxicity of the test item was determined in pre-experiments. Eight concentrations [0.0025, 0.005, 0.01, 0.050, 0.10, 0.25, 0.50, 1.0 mM] were tested without and with metabolic activation. In the pre-experiment the test item concentrations were dissolved in 1% ethanol and 9% phosphate buffer. The experimental performance for the pre-experiment was the same as described below for the main experiments (excepting the solvent composition)
COMPARISON WITH HISTORICAL CONTROL DATA:
In all experiments the mutant values of the negative controls, the solvent controls and all mutant values of the test item concentrations found were within the historical control data of the test facility (without metabolic activation: 2-43 mutants per 10^6 cells, with metabolic activation: 5-44 mutants per 10^6 cells - Conclusions:
- Under the experimental conditions, the test item Niobium pentachloride (decomposed) is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
- Executive summary:
In a mammalian cell HPRT gene mutation assay, V79 cells cultured in vitro were exposed to Niobium pentachloride (decomposed) (99.9 %) in 1% ethanol and 9% Aqua ad injectibilia at concentrations of 0.025, 0.05, 0.10, 0.25, 0.50, 0.75, 1.0, 1.5 and 2.0 mM in the presence and absence of mammalian metabolic activation (experiment I) and for experiment II at concentrations of 0.005, 0.010, 0.025, 0.050, 0.10, 0.25, 0.50, 0.75 and 1.0 mM without metabolic activation and 0.004, 0.007, 0.02, 0.04, 0.07, 0.2, 0.4, 0.7 and 1.0 mM with metabolic activation.
In experiment I and II with and without metabolic activation mutant values of the negative controls, the solvent controls and all mutant values of the test item concentrations found were within the historical control data.
For all tested treatment groups no dose-response relationship could be observed. The positive controls did induce the appropriate response. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
Referenceopen allclose all
Table 1: Concentrations of Metals Required to Induce a a Significant Harmful Effect (DNA Damage, Apoptosis, Viability, and Proliferation Inhibition) on T-Helper Jurkat Cells | |||||
Metal Concentrations (mM) |
DNA Damage |
Apoptosis | Viability | Proliferation Inhibition | Average Concentration of Four Parameters |
V | 0.05 | 0.05 | 1.0 | 0.05 | 0.29 |
Ni | 0.05 | 0.1 | 5.0 | 0.5 | 1.41 |
Co | 5.0 | 5.00 | 0.5 | 0.1 | 2.65 |
Cu | >5 | 0.5 | 5.0 | 0.1 | >2.65 |
Nb | >5 | 0.5 | 0.5 | >5 | >2.75 |
Mo | >5 | 1.0 | >5 | 0.5 | >2.87 |
Zr | 5.0 | 0.5 | 5.0 | >5 | >3.875 |
Be | >5 | 5.0 | 1.0 | 5.0 | >4 |
Cr | >5 | >5 | >5 | >5 | >5 |
Al | >5 | 5.0 | >5 | >5 | >5 |
Fe | >5 | 5.0 | >5 | >5 | >5 |
Significant effect: | |||||
DNA damage: IDD>75. | |||||
Apoptosis: >50% caspase 9-positive cells. | |||||
Viability: >50% PI-positive cells. | |||||
Proliferation inhibition: p< 0.05 significance in metal-treated cells CPMs reduction compared to untreated controls. |
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
Table 1 | ||||||||||
Experiment I - Mutagenicity, without metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 6 | 6 | 9 | 10 | 6 | 7.4 | 1.74 | 20.11 | |
NC2 | 4 | 6 | 6 | * | 8 | 6 | 1.41 | 18.29 | ||
S1 | 0 | 9 | 10 | 13 | 16 | 10 | 11.6 | 2.58 | 33.72 | |
S2 | 7 | 6 | 9 | 8 | 10 | 8 | 1.41 | 23.46 | ||
2 | 0.025 | 6 | 6 | 5 | 14 | 9 | 8 | 3.29 | 20.05 | 0.69 |
3 | 0.05 | 5 | 3 | 6 | 2 | 8 | 4.8 | 2.14 | 14.08 | 0.48 |
4 | 0.1 | 4 | 4 | 6 | 5 | 12 | 6.2 | 2.99 | 18.34 | 0.63 |
5 | 0.25 | 9 | 10 | 10 | 7 | 5 | 8.2 | 1.94 | 25.39 | 0.87 |
6 | 0.5 | 6 | 11 | 5 | 5 | 7 | 6.8 | 2.23 | 18.28 | 0.63 |
7 | 0.75 | 15 | 14 | 11 | 15 | 18 | 14.6 | 2.24 | 40.67 | 1.4 |
8 | 1.0 | 9 | 6 | 6 | 12 | 12 | 9 | 2.68 | 25.86 | 0.89 |
9 | 1.5 | 3 | 5 | 5 | 4 | 7 | 4.8 | 1.33 | 14.72 | 0.51 |
10 | 2.0 | 9 | 13 | 6 | 9 | 6 | 8.6 | 2.58 | 25.83 | 0.89 |
EMS | 300 µg/mL | 84 | 72 | 80 | 89 | 90 | 83 | 6.57 | 233.15 | 8.01 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
EMS: | Ethylmethanesulfonate [300 µg/mL] | |||||||||
*: | Contamination of cell culture in flask |
Table 2 | ||||||||||
Experiment I - Mutagenicity, with metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 5 | 5 | 6 | 6 | 11 | 6.6 | 2.24 | 20.06 | |
NC2 | 2 | 5 | 7 | 11 | 11 | 7.2 | 3.49 | 20.11 | ||
S1 | 0 | 3 | 5 | 6 | 7 | 10 | 6.2 | 2.32 | 18.62 | |
S2 | 3 | 4 | 9 | 9 | 10 | 7.0 | 2.90 | 19.83 | ||
2 | 0.025 | 4 | 4 | 5 | 6 | 10 | 5.8 | 2.23 | 14.61 | 0.76 |
3 | 0.05 | 5 | 12 | 8 | 3 | 8 | 7.2 | 3.06 | 18.56 | 0.97 |
4 | 0.10 | 11 | 10 | 11 | 10 | 11 | 10.6 | 0.49 | 30.64 | 1.59 |
5 | 0.25 | 5 | 6 | 7 | 10 | 14 | 8.4 | 3.26 | 20.64 | 1.07 |
6 | 0.50 | 2 | 2 | 4 | 5 | 5 | 3.6 | 1.36 | 9.65 | 0.50 |
7 | 0.75 | 3 | 7 | 8 | 9 | 9 | 7.2 | 2.23 | 19.15 | 1.00 |
8 | 1.0 | 4 | 8 | 11 | 12 | 12 | 9.4 | 3.07 | 25.61 | 1.33 |
9 | 1.5 | 7 | 7 | 8 | 8 | 9 | 7.8 | 0.75 | 18.22 | 0.95 |
10 | 2.0 | 7 | 7 | 9 | 9 | 11 | 8.6 | 1.50 | 22.34 | 1.16 |
DMBA | 0.8µg/mL | 105 | 107 | 133 | 96 | 97 | 107.6 | 13.41 | 303.95 | 15.81 |
DMBA | 1.0µg/mL | 111 | 149 | 118 | 122 | 109 | 121.8 | 14.39 | 369.09 | 19.20 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
DMBA: | 7, 12-Dimethylbenz(a)anthracene [0.8 and 1.0 µg/mL] |
Table 3 | ||||||||||
Experiment II - Mutagenicity, without metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 8 | 9 | 10 | 6 | 5 | 7.6 | 1.85 | 21.05 | |
NC2 | 14 | 8 | 5 | 9 | 12 | 9.6 | 3.14 | 26.89 | ||
S1 | 0 | 15 | 7 | 8 | 9 | 12 | 10.2 | 2.93 | 29.74 | |
S2 | 9 | 12 | 9 | 8 | 5 | 8.6 | 2.24 | 24.02 | ||
2 | 0.025 | 16 | 4 | 8 | 5 | 6 | 7.8 | 4.31 | 25.91 | 0.96 |
3 | 0.010 | 10 | 12 | 12 | 11 | 7 | 10.4 | 1.85 | 33.02 | 1.23 |
4 | 0.025 | 12 | 5 | 10 | 10 | 5 | 8.4 | 2.87 | 25.23 | 0.94 |
5 | 0.050 | 15 | 15 | 8 | 13 | 13 | 12.8 | 2.56 | 36.57 | 1.36 |
6 | 0.10 | 8 | 18 | 12 | 18 | 14 | 14.0 | 3.79 | 39.11 | 1.45 |
7 | 0.25 | 10 | 10 | 7 | 10 | 10 | 9.4 | 1.2 | 26.26 | 0.98 |
8 | 0.50 | 16 | 10 | 13 | 8 | 20 | 13.4 | 4.27 | 37.22 | 1.38 |
9 | 0.75 | 14 | 7 | 18 | 16 | 15 | 14.0 | 3.74 | 35.90 | 1.34 |
10 | 1.0 | 9 | 12 | 8 | 11 | 8 | 9.6 | 1.62 | 27.12 | 1.01 |
EMS | 300µg/mL | 160 | 175 | 179 | 169 | 177 | 172.0 | 6.87 | 607.77 | 22.61 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
EMS: | Ethylmethanesulfonate [300 µg/mL] |
Table 4 | ||||||||||
Experiment II - Mutagenicity, with metabolic activation | ||||||||||
Dose Group | Concentration [mM] | Number of mutant colonies per flaska | Mean | SD | Mutant SD colonies per 106 cellsb |
Mutation factor | ||||
I | II | III | IV | V | ||||||
NC1 | 0 | 13 | 10 | 8 | 11 | 3 | 9.0 | 3.41 | 24.93 | |
NC2 | 19 | 12 | 18 | 12 | 16 | 15.4 | 2.94 | 43.38 | ||
S1 | 0 | 3 | 8 | 6 | 5 | 3 | 5.0 | 1.90 | 13.7 | |
S2 | 9 | 7 | 12 | 13 | 5 | 9.2 | 2.99 | 25.41 | ||
2 | 0.004 | 13 | 13 | 8 | 13 | 6 | 10.6 | 3.01 | 26.84 | 1.37 |
3 | 0.01 | 4 | 10 | 8 | 7 | 8 | 7.4 | 1.96 | 20.11 | 1.03 |
4 | 0.02 | 5 | 12 | 7 | 11 | 7 | 8.4 | 2.65 | 22.22 | 1.14 |
5 | 0.04 | 9 | 8 | 11 | 12 | 6 | 9.2 | 2.14 | 23.41 | 1.20 |
6 | 0.07 | 15 | 6 | 10 | 12 | 7 | 10.0 | 3.29 | 25.71 | 1.31 |
7 | 0.2 | 7 | 8 | 4 | 11 | 14 | 8.8 | 3.43 | 26.19 | 1.34 |
8 | 0.4 | 9 | 13 | 14 | 17 | 13 | 13.2 | 2.56 | 35.97 | 1.84 |
9 | 0.7 | 9 | 13 | 12 | 9 | 6 | 9.8 | 2.48 | 29.17 | 1.49 |
10 | 1.0 | 13 | 10 | 14 | 12 | 13 | 12.4 | 1.36 | 35.63 | 1.82 |
DMBA | 0.8µg/mL | 77 | 89 | 71 | 88 | 90 | 83.0 | 7.62 | 244.12 | 12.48 |
DMBA | 1.0µg/mL | 109 | 120 | 126 | 106 | 114 | 115.0 | 7.27 | 357.14 | 18.26 |
NC: | negative control/ medium control | |||||||||
S: | solvent control | |||||||||
a: | number of mutant colonies in flask I to V | |||||||||
b: | mean mutant colonies x 106/ (400000 x Cloning Efficiency/100) | |||||||||
DMBA: | 7, 12-Dimethylbenz(a)anthracene [0.8 and 1.0 µg/mL] |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available for Niobium dioxide (target substance). Thus, available data from Niobium oxide and Niobium pentachloride (source substances) are used to assess in a read-across approach the genotoxicity of Niobium dioxide. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
The source substance Niobium oxide was not genotoxic in a bacterial reverse gene mutation assay (Ames test). The second source substance Niobium pentachloride was tested negative in an in vitro HPRT test conducted according to OECD 476 and furthermore in an in vitro Comet assay.Justification for classification or non-classification
Based on available data from suitable read-across partners, the target substance Niobium dioxide does not warrant classification for mutagenicity.
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.
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