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EC number: 215-213-6 | CAS number: 1313-96-8
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 July 2009 to 18 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Diniobium pentaoxide
- EC Number:
- 215-213-6
- EC Name:
- Diniobium pentaoxide
- Cas Number:
- 1313-96-8
- Molecular formula:
- Nb2O5
- IUPAC Name:
- diniobium(5+) pentaoxidandiide
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix obtained from Wistar rats
- Test concentrations with justification for top dose:
- See details given below.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- The Cells
V79 cells in vitro were widely used to examine the ability of chemicals to induce cytogenetic changes and thus identify potential carcinogens or mutagens. These cells were chosen because of their relatively small number of chromosomes (diploid number, 2n = 22), their high proliferation rate (doubling time of the BSL BIOSERVICE V79 done in stock cultures: 12 – 14 h) and the high plating efficiency of untreated cells (normally more than 50%). These facts were necessary for the appropriate performance of the study.
The V79 (ATCC, CCL-93) cells are stored over liquid nitrogen (vapour phase) in the cell bank of BSL BIOSERVICE, as large stock cultures allowing the repeated use of the same cell culture batch in experiments. Routine checking for mycoplasma infections was carried out before freezing.
For the experiment, thawed cultures were set up in 75 cm2 cell culture plastic flasks at 37 oC in a 5% carbon dioxide atmosphere (95% air). 5 x 105 cells per flask were seeded in 15 mL of MEM (minimum essential medium) supplemented with 10% FCS (foetal calf serum) and subcultures were made every 3 - 4 days.
Mammalian Microsomal Fraction S9 Mix
An advantage of using in vitro cell cultures was the accurate control of the concentration and exposure time of cells to the test item under study. However, due to the limited capacity of cells growing in vitro for metabolic activation of potential mutagens, an exogenous metabolic activation system was necessary (5). Many substances only develop mutagenic potential when they are metabolised by the mammalian organism. Metabolic activation of substances can be achieved by supplementing the cell cultures with liver microsome preparations (S9 mix).
The S9 liver microsomal fraction was prepared at BSL BIOSERVICE GmbH. Male Wistar rats were induced with Phenobarbital (80 mg/kg bw) and β-Naphthoflavone (100 mg/kg bw).
The following quality control determinations were performed:
a) Biological activity in the Salmonella typhimurium assay
Sterility Test
A stock of the supernatant containing the microsomes was frozen in ampoules of 2 and 4.5 mL and stored at ≤-75 °C.
The protein concentration in the S9 preparation (Lot: 250609) was 31 mg/mL.
S9 Mix
An appropriate quantity of the S9 supernatant was thawed and mixed with S9 cofactor solution to result in a final protein concentration of 0.75 mg/mL in the cultures. Cofactors were added to the S9 mix to reach the following concentrations:
8 mM MgCl2
33 mM KCl
5 mM Glucose-6-phosphate
5 mM NADP
in 100 mM sodium-phosphate-buffer pH 7.4. During the experiment the S9 mix was stored on ice. - Evaluation criteria:
- according to the guideline
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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
Any other information on results incl. tables
In an in vitro chromosome aberration assay, the test item Diniobium Pentaoxide was investigated for the potential to induce structural chromosomal aberrations in Chinese hamster V79 cells in the absence and presence of metabolic activation with S9 homogenate.
The selection of the concentrations used in experiment I and II was based on data from the solubility test and the pre-experiment which were performed according to the guidelines.
In experiment I, without metabolic activation 1000 μg/mL and with metabolic activation 2500 μg/mL were selected as highest dose groups for the microscopic analysis of chromosomal aberrations. In experiment II, without metabolic activation 500 μg/mL and with metabolic activation 2000 μg/mL were selected as highest dose groups for the microscopic analysis of chromosomal aberrations.
The chromosomes were prepared 20 h after start of treatment with the test item. The treatment intervals were 4 h with and without metabolic activation (experiment I) and 4 h with and 20 h without metabolic activation (experiment II). Two parallel cultures were set up. 100 metaphases per culture were scored for structural chromosomal aberrations.
The following concentrations were evaluated for microscopic analysis:
Experiment I:
With metabolic activation: 500, 1000 and 2500 μg/mL
Without metabolic activation: 250, 500 and 1000 μg/mL
Experiment II:
With metabolic activation: 500, 1000 and 2000 μg/mL
Without metabolic activation: 125, 250 and 500 μg/mL
Precipitation:
In experiment I and II, precipitation of the test item was noted with and without metabolic activation at all the concentrations evaluated.
Toxicity:
In experiment I, without metabolic activation, a biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at 500 μg/mL and higher (55% at 500 μg/mL and 44% at 1000 μg/mL).With metabolic activation a biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at 2500 μg/mL (59%). The cell density was not decreased with and without metabolic activation.
In experiment II without metabolic activation, a biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at 500 μg/mL (65%).With metabolic activation, no biologically relevant decrease of the relative mitotic index (decrease below 70% rel. mitotic index) was noted at concentrations evaluated. No decrease of the cell density was noted with and without metabolic activation.
Clastogenicity:
In experiment I without metabolic activation the aberration rate of the negative control (2.5%) and all the dose groups treated with the test item (1.5% (250 μg/mL), 1.5% (500 μg/mL) and 2.0% (1000 μg/mL)) were within the historical control data of the testing facility (0.0% – 4.0%).With metabolic activation, the aberration rates of the negative control (2.5%) and all dose groups treated with the test item 500 μg/mL (0.5%), 1000 μg/mL (0.5%) and 2500 μg/mL (1.0%) were within the historical control data of the testing facility (0.0% – 4.0%). The number of aberrant cells found in the dose groups treated with the test item did not show a biologically relevant increase compared to the corresponding negative control. In addition, no dose-response relationship was observed.
In experiment II without metabolic activation the aberration rate of the negative control (1.0%) and all dose groups treated with the test item (1.5% (125 μg/mL), 1.0% (250 μg/mL) and 1.5% (500 μg/mL)) were within the historical control data of the testing facility (0.0% – 4.0%).With metabolic activation the aberration rates of the negative control (2.0%) and all dose groups treated with the test item (1.0% (500 μg/mL), 1.0% (1000 μg/mL), and 2.0 (2000 μg/mL)) were within the historical control data of the testing facility (0.0% – 4.0%). The number of aberrant cells found in the dose groups treated with the test item did not show a biologically relevant increase compared to the corresponding negative control. In addition, no dose-response relationship was observed.
Polyploid cells:
No biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item.
EMS (400 and 600 μg/mL) and CPA (0.83 μg/mL) were used as positive controls and induced distinct and biologically relevant increases in cells with structural chromosomal aberrations.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test item Diniobium Pentaoxide did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line.
Therefore, the test item Diniobium Pentaoxide is considered to be non-clastogenic.
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