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EC number: 215-238-2 | CAS number: 1314-61-0
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 December 2012 to 16 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - 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:
- Ditantalum pentaoxide
- EC Number:
- 215-238-2
- EC Name:
- Ditantalum pentaoxide
- Cas Number:
- 1314-61-0
- Molecular formula:
- O5Ta2
- IUPAC Name:
- ditantalum(5+) pentaoxidandiide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: White powder.
- Storage condition of test material: Controlled room temperature (15 - 25 ºC, below 70 RH %).
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Dulbecco’s Modified Eagle’s Medium supplemented with 2 mM
L-glutamine, 1 (v/v) % Antibiotic-antimycotic solution (standard content: 10000 NE/mL penicillin, 10 mg/mL streptomycin and 25 g/mL amphotericin-B) and 10 (v/v) % heat-inactivated fetal bovine serum (DMEM-10, culture medium). During the treatments, the serum content of the medium was reduced to 5 (v/v) % (DMEM-5).
- Properly maintained: Yes, cell stocks were kept in a freezer at -80 ± 10°C. Trypsin-EDTA (0.25% Trypsin, 1mM EDTA) solution was used for cell detachment to subculture (cells were rinsed with 1X PBS before detachment). The laboratory cultures were maintained in 150 cm2 plastic flasks at 37 ± 0.5 °C in a humidified atmosphere containing approximately 5% CO2 in air.
- Periodically checked for Mycoplasma contamination: Yes. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- > Experiment without metabolic activation: 2000, 1000, 500, 250, 125, 62.5 and 31.25 µg/mL
> Experiment with metabolic activation: 4000, 2000, 1000, 500, 250, 125, 62.5 and 31.25 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO.
- Justification for choice of solvent/vehicle: Based on the preliminary solubility test, no proper formulation of the test material could be made at 500, 250 or 100 mg/mL using Distilled water. However, a formulation at a concentration of 500 mg/mL using Dimethyl sulfoxide (DMSO) as vehicle was suitable for the test. As DMSO is compatible to the test system, it was selected as the vehicle for the study. The highest examined concentration in the preliminary test was 5000 µg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium.
DURATION
- Preincubation period: 1-3 day old cultures were incubated without the test solution for approximately 24 hours at 37 °C in 10 mL of culture medium.
- Exposure duration:
> Assay 1: 3 hours with and without S9 mix,.
> Assay 2: 3 hours with and 20 hours without S9 mix.
- Fixation time (start of exposure up to harvest of cells):
> Assay 1: 20 hours.
> Assay 2: 28 hours.
SPINDLE INHIBITOR: Colchicine (0.2 µg/mL).
STAIN: 5% Giemsa solution.
NUMBER OF REPLICATIONS: Duplicate.
NUMBER OF CELLS EVALUATED: At least one hundred metaphases with 22 ± 2 chromosomes (dicentric chromosomes were counted as two chromosomes) from each culture were examined for the presence or absence of chromosomal aberrations (approximately 1000x magnification), where possible, for a total of 200 metaphases per concentration. Chromatid and chromosome type aberrations (gaps, deletions and exchanges) were recorded separately.
DETERMINATION OF CYTOTOXICITY
- Method: % Relative survival.
OTHER EXAMINATIONS:
- Polyploidy and endoreplication’s were scored.
- Other: Marked reductions in the numbers of cells on the slides were recorded if needed.
PRELIMINARY TEST:
- A preliminary test was performed to determined cytotoxicity. The test was performed as described for the main test; except single cultures were used and positive controls were not included. Two separate assays were performed, A and B. In Assay A, cells were treated for 3-hours in the presence and absence of S9-mix with a 20-hour harvesting time. In Assay B, cells were treated for 3 hours in the presence of S9-mix and for 20 hours in the absence of S9-mix with a 28-hour harvesting time.
- Concentrations: A total of eight test concentrations between 5000 and 39.06 μg/mL were used to evaluate toxicity in the presence and absence of metabolic activation in each cytotoxicity assay.
- Evaluation: At the scheduled harvesting time, the number of surviving cells was determined using a haemocytometer. Results are expressed compared to the negative (vehicle) control as % relative survival. - Evaluation criteria:
- The assay is considered valid, if the following criteria are met:
> The negative (vehicle) control data are within the laboratory’s normal range for the spontaneous aberration frequency.
> The positive controls induce increases in the aberration frequency, which are significant.
The test material is considered to have shown clastogenic activity in this study if all of the following criteria are met:
> Increases in the frequency of metaphases with aberrant chromosomes are observed at one or more test concentrations (only data without gaps will be considered).
> The increases are reproducible between replicate cultures and between tests (when treatment conditions were the same).
> The increases are statistically significant.
> The increases are not associated with large changes in pH or osmolarity of the treated cultures.
The historical control data for this laboratory were also considered in the evaluation. Evidence of a dose-response relationship (if any) was considered to support the conclusion.
The test material is concluded to have given a negative response if no reproducible, statistically significant increases are observed. - Statistics:
- For statistical analysis, Fisher’s exact test was used. The parameter evaluated for statistical analysis was the number of cells with one or more chromosomal aberrations excluding gaps.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- observed at concentrations of 500 µg/mL or greater
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- CHROMOSOME ABERRATION ASSAYS
None of the treatment concentrations caused a biologically significant increase in the number of cells with structural chromosome aberrations in either assay with or without metabolic activation. At 2000 µg/mL with metabolic activation in Assay 1, a marginal statistically significant increase was recorded, compared with the corresponding negative control which had no aberrant cells in either replicate. However, both replicates at 2000 µg/mL were observed to have 3 aberrant cells, which is well within the negative historical control range of 0-5.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No large changes were observed.
- Effects of osmolality: No large changes were observed.
- Water solubility:
> In Assay 1, insolubility was detected at the end of the treatment period in the final treatment medium in the 2000-125 µg/mL concentration range (experiment without metabolic activation) or 4000-125 µg/mL concentration range (experiment with metabolic activation).
> In Assay 2, similarly to the first experiment, insolubility was detected at the end of the treatment period in the final treatment medium in the 2000-250 µg/mL concentration range (experiment without metabolic activation) or 4000-125 µg/mL concentration range (experiment with metabolic activation).
COMPARISON WITH HISTORICAL CONTROL DATA: The spontaneous aberration frequencies of the negative (vehicle) controls in the performed experiments were within the historical control range of the testing laboratory.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
> In Assay 1, marked cytotoxicity was observed at 2000, 1000 and 500 µg/mL without metabolic activation (relative survival values were 21, 28 and 50%, respectively) and at 4000 and 2000 µg/mL with metabolic activation (relative survival values were 49 and 49%, respectively).
> In Assay 2, cytotoxicity was also observed at 2000, 1000 and 500 µg/mL without metabolic activation (relative survival values were 25, 25 and 49%, respectively) and at 4000, 2000 and 1000 µg/mL with metabolic activation (relative survival values were 35, 42 and 43%, respectively).
ADDITIONAL INFORMATION ON POLYPLOID ABD ENDOREDUPLICATED METAPHASES:
Polyploid metaphases (1 - 2) were found in some cases in the negative (vehicle) control or test item treated samples in the performed experiments. Endoreduplicated metaphases (1 - 2) were found in some cases in the positive control or test item treated samples in the performed experiments. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary of Results Main Assay 1
Concentration (µg/mL) |
Time of Treatment/Sampling |
Relative Survival (%)# |
Insolubility## |
Mean % Aberrant Cells### |
Without metabolic activation (-S9) |
||||
Negative control |
3 h/20 h |
100 |
- |
0.5 |
2000 |
3 h/20 h |
21 |
+ |
NE |
1000 |
3 h/20 h |
28 |
+ |
NE |
500 |
3 h/20 h |
50 |
+ |
0.0 |
250 |
3 h/20 h |
64 |
+a |
0.5 |
125 |
3 h/20 h |
90 |
+a |
0.0 |
62.5 |
3 h/20 h |
90 |
-b |
NE |
31.25 |
3 h/20 h |
96 |
- |
NE |
Positive Control |
3 h/20 h |
72 |
- |
16.9*** |
With metabolic activation (+S9) |
||||
Negative control |
3 h/20 h |
100 |
- |
0.0 |
4000 |
3 h/20 h |
49 |
+ |
NE |
2000 |
3 h/20 h |
49 |
+ |
3.0* |
1000 |
3 h/20 h |
67 |
+ |
2.5 |
500 |
3 h/20 h |
82 |
+ |
2.0 |
250 |
3 h/20 h |
79 |
+a |
NE |
125 |
3 h/20 h |
83 |
+a |
NE |
62.5 |
3 h/20 h |
91 |
-b |
NE |
31.25 |
3 h/20 h |
88 |
- |
NE |
Positive Control |
3 h/20 h |
57 |
- |
93.8*** |
Table 2: Summary of Results Main Assay 2
Concentration (µg/mL) |
Time of Treatment/Sampling |
Relative Survival (%)# |
Insolubility## |
Mean % Aberrant Cells### |
Without metabolic activation (-S9) |
||||
Negative control |
20 h/28 h |
100 |
- |
2.0 |
2000 |
20 h/28 h |
25 |
+ |
NE |
1000 |
20 h/28 h |
25 |
+ |
NE |
500 |
20 h/28 h |
49 |
+ |
4.0 |
250 |
20 h/28 h |
78 |
+a |
3.0 |
125 |
20 h/28 h |
81 |
-b |
1.0 |
62.5 |
20 h/28 h |
91 |
-b |
NE |
31.25 |
20 h/28 h |
87 |
- |
NE |
Positive Control |
20 h/28 h |
56 |
- |
21.0*** |
With metabolic activation (+S9) |
||||
Negative control |
3 h/28 h |
100 |
- |
3.5 |
4000 |
3 h/28 h |
35 |
+ |
NE |
2000 |
3 h/28 h |
42 |
+ |
NE |
1000 |
3 h/28 h |
43 |
+ |
2.0 |
500 |
3 h/28 h |
64 |
+ |
4.0 |
250 |
3 h/28 h |
75 |
+a |
5.5 |
125 |
3 h/28 h |
100 |
+a |
1.5 |
62.5 |
3 h/28 h |
98 |
-b |
NE |
31.25 |
3 h/28 h |
84 |
- |
NE |
Positive Control |
3 h/28 h |
67 |
- |
36.1*** |
Negative (vehicle) control: 1% (v/v) DMSO
Positive control (-S9): Ethyl methanesulfonate, 1 µL/mL
Positive control (+S9): Cyclophosphamide, 6 µg/mL
NE: not evaluated
#: compared to the negative (vehicle) control
##: in the final treatment medium at the end of the treatment
###: excluding gaps
a: Minimal amount of precipitate/opalescence was observed
b: Discoloured medium
*: p<0.05 comparing numbers of aberrant cells excluding gaps with corresponding negative control
***: p<0.001 comparing numbers of aberrant cells excluding gaps with corresponding negative control
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the conditions of the test, the test material did not induce chromosome aberrations in the performed experiments with or without metabolic activation. The test material is therefore considered not to be clastogenic in this test system. - Executive summary:
The clastogenic potential of the test material with and without metabolic activation was determined in an in vitro mammalian chromosome aberration test. The study was conducted under GLP conditions and in line with the standardised guidelines OECD 473, EU Method B. 10 and EPA OPPTS 870.5375. Two chromosome aberration assays were performed using Chinese hamster lung fibroblasts (V79) cells. In Assay 1, cells were exposed to the test material for 3 hours with and without metabolic activation and given a 20 hour fixation time. In assay 2, cells were exposed to the test material for 3 hours with and 20 hours without metabolic activation, both were given a fixation time of 28 hours.
Under the conditions of the test, exposure to the test material with or without metabolic activation did not result in a statistically and biologically significant, repeatable, dose-dependent increase in the frequency of the cells with structural chromosome aberrations. Cytotoxicity was observed with and without metabolic activation at concentrations of ≥ 1000 µg/mL and 500 µg/mL, respectively. Therefore, the test material is not considered to be clastogenic in this test system.
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