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EC number: - | CAS number: -
- 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:
- key study
- Study period:
- Jan 9, 2018 to Feb 1, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cesium tungstate (Cs0.33WO3)
- Cas Number:
- 189619-69-0
- Molecular formula:
- Cs0.33WO3
- IUPAC Name:
- Cesium tungstate (Cs0.33WO3)
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- Test item name: Cesium Tungsten Oxide
Batch no.: B0345
Purity: >99%
Homogeneity: homogeneous
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Details on mammalian cell type (if applicable):
- Source: TRINOVA BioChem GmbH
Batch: 4997D
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Source: TRINOVA BioChem GmbH
Batch: 5011D
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Source: TRINOVA BioChem GmbH
Batch: 4996D
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Source: TRINOVA BioChem CmbH
Batch: 4982D
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Source: TRINOVA BioCehm GmbH
Batch: 5012D
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 produced from livers of male Sprague-Dawley rats treated with Aroclor
- Test concentrations with justification for top dose:
- 1st experiment: 5000 / 1500 / 500 / 150 / 50 μg/plate
2nd experiment: 5000 / 2500 / 1250 / 625 / 313 / 156 / 78 μg/plate
Justification for top dose: The test item showed precipitates were observed on the plates at the highest concentration only (5000 μg/plate) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: demineralized water
- Justification for choice of solvent/vehicle: Out of the three solvents tested (demin. water, DMSO, acetone), this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide (DMSO) and Demineralised water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, C6H7N3O2; CAS-No.: 99-56-9 2-Amino-anthracene, C14H11N; CAS-No.: 613-13-8
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- First experiment: in agar (plate incorporation)
- Second experiment: preincubation
- Cell density at seeding (if applicable): 10^9 cells/mL
DURATION
- For the culture of bacteria prior to the start of the experiments: 8 hrs, overnight at 37 ± 1 °C
- For the second experiment (pre-incubation method) only: pre-incubated for 20 minutes at 37 ± 1 °C
- The titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. Incubation for 48 hours at 37 ±1 °C followed.
NUMBER OF REPLICATIONS: three plates with and three plates without metabolic activation (-S9) were used. - Evaluation criteria:
- - colonies were counted visually and the numbers were recorded.
- a substance was considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain could be observed. A concentration-related increase over the range tested was also taken as a sign of mutagenic activity. - Statistics:
- - mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item suspensions and the positive controls. Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants minus mean spontaneous revertants) was given.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the second experiment, the test item showed signs of toxicity towards the bacteria strain TA98 in both the absence and presence of metabolic activation at the highest concentration (5000 μg/plate).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Concentrations of the test item are stated as nominal concentrations, as suspensions had to be tested due to the poor solubility of the test item. As no complete dissolution was possible, undissolved particles were visible on the plates, only at the highest concentrations.
Any other information on results incl. tables
Observations from the First experiment (plate incorporation method):
Confirmation of the Criteria and Validity
All strains met the criterion of at least 10^9 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory (historical data of the laboratory). All positive controls showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
Solubility and Toxicity
In the first experiment, the test item showed precipitates were observed on the plates at the highest concentration only (5000 μg/plate). No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Observations from the Second experiment (preincubation method):
Confirmation of the Criteria and Validity
All strains met the criterion of at least 10^9 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory (historical data of the laboratory). All positive controls showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
Solubility and Toxicity
In the second experiment, the test item showed precipitates on the plates at the highest concentration. The bacterial background lawn was not reduced at any of the concentrations, but a relevant decrease in the number of revertants was observed in the bacteria strain TA98 at the highest concentration (5000 μg/plate), only. The test item showed signs of toxicity towards the bacteria strain TA98 in both the absence and presence of metabolic activation at the highest concentration (5000 μg/plate).
Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Cesium Tungsten Oxide is not mutagenic in the "Salmonella typhimurium" strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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