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EC number: 234-744-4 | CAS number: 12030-85-2
- 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
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- Flash point
- Auto flammability
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- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Specific investigations
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- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-01-07 to 2015-04-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Rationale for reliability: guideline study from supporting substance (structural analogue)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Niobium pentachloride
- EC Number:
- 233-059-8
- EC Name:
- Niobium pentachloride
- Cas Number:
- 10026-12-7
- Molecular formula:
- Cl5Nb
- IUPAC Name:
- Niobium(V) chloride
- Details on test material:
- - Name of test material (as cited in study report): Niobium pentachlorid (decomposed)
- Analytical purity: 99.9%
- Lot/batch No.: 146149
- Expiration date of the lot/batch: 2016-05-14
- Physical state: solid
- Storage condition of test material: at < -5° C, protected from light and humidity
- Other: Hydrolysis in water at room temperature
Constituent 1
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Type and identity of media:
Short-term exposure: MEM medium, 100 U/100 µg/ml penicillin/streptomycin, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/ml amphotericin B
Long-term exposure: MEM Medium with 10 % fetal bovine serum (FBS), 100 U/100 µg/ml penicillin/streptomycin, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/ml amphotericin B
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal liver enzymes (S9)
- Test concentrations with justification for top dose:
- Pre-test for toxicity: 0, 0.0025, 0.005, 0.01, 0.05, 0.10, 0.25, 0.50, 1.0 mM without/with S9 mix
Main test:
Experiment I: 0, 0.025, 0.05, 0.10, 0.25, 0.50, 0.75, 1.0, 1.5 and 2.0 mM without/with S9 mix
Experiment II: 0, 0.005, 0.010, 0.025, 0.050, 0.10, 0.25, 0.50, 0.75, 1.0 mM without S9 mix
Experiment II: 0, 0.004, 0.007, 0.02, 0.04, 0.07, 0.2, 0.4, 0.7, 1.0 mM with S9 mix - Vehicle / solvent:
- - vehicle/solvent used: 1% Ethanol/9% Aqua ad injectabilia
- justification for choice of solvent: Solubility test and pre-test for toxicity
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Treatment medium (MEM Medium)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1% ethanol/9% Aqua ad injectabilia
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation, final concentration 300 µg/ml
- Untreated negative controls:
- yes
- Remarks:
- Treatment medium (MEM Medium) plus S9 mix
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1 % ethanol/9% Aqua ad injectabilia plus S9 mix
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation, final concentration 0.8 and 1.0 µg/ml
- Details on test system and experimental conditions:
- Method of application: in medium
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hours (short time exposure, Experiment I with and without metabolic activation)
20 hours (long time exposure, Experiment II with and without metabolic activation)
- Expression time (cells in growth medium): 6 days (subcultered after 3 days)
- Selection time (if incubation with a selection agent): 7-11 days
- Fixation time (start of exposure up to fixation or harvest of cells): 13-17 days
SELECTION AGENT (mutation assays): 6-Thioguanine
NUMBER OF REPLICATIONS: one culture per test group (expression period), 5 dishes per culture per test group (selection period)
DETERMINATION OF CYTOTOXICITY
- Methods: Relative Growth, Cloning efficiency - Evaluation criteria:
- - Negative and/or solvent controls fall within the performing laboratories historical control data range: 2-44 mutants/10^6 cells
-The absolute cloning efficiency: ([number of positive cultures x 100] I total number of seeded cultures) of the negative and /or
solvent controls is > 50%
-The positive controls (EMS and DMBA) induce significant increases (at least 3-fold increase of mutant frequencies related to the comparable negative control values and higher than the historical range of negative controls) in the mutant frequencies.
- A test is considered to be negative if there is no biological relevant increase in the number of mutants.
- There are several criteria for determining a positive result: a reproducible three times higher mutation frequency than the solvent control for at least one of the concentrations
- a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a three-fold increase of the mutant frequency is not observed
- if there is by chance a low spontaneous mutation rate in the corresponding negative and solvent controls a concentration related increase of the mutations within their range has to be discussed.
- According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test results
- 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 - Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 4 | ||||||||||
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 | 2.58 | 33.72 | |
S2 | 7 | 6 | 9 | 8 | 10 | 11.6 | 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 6 | ||||||||||
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 8 | ||||||||||
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 10 | ||||||||||
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] |
Applicant's summary and conclusion
- 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.
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