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EC number: 261-919-2 | CAS number: 59766-31-3
- 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:
- 02 March 2011 - 25 March 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- This study was performed in accordance with the guideline set forth in "Standards for Mutagenicity Tests with Microorganisms" (Notification No. 77, September 1, 1988 & Notification No. 67, June 2, 1997 & Notification No. 120, December 25, 2000, Ministry of Labour, Japan) and "Revision of the form for report of results of mutagenicity test using microorganisms" (Notification No.653, September 29, 1997, Labour Standards Bureau, Ministry of Labour, Japan). And it was conducted in compliance with the "Standards to be observed by Mutagenicity Testing Institutions(Notification No.76, September 1, 1988 & Notification No. 13, March 29, 2000 & Notification No. 120, December 25, 2000, Ministry of Labour, Japan)”
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dipotassium titanate(2-)
- EC Number:
- 261-919-2
- EC Name:
- Dipotassium titanate(2-)
- Cas Number:
- 59766-31-3
- Molecular formula:
- K2O17Ti8
- IUPAC Name:
- dipotassium titanate(2-)
- Test material form:
- solid: crystalline
- Details on test material:
- Appearance: White acicular crystal
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Dose range finder: 1.2, 4.9, 20, 78, 313, 1250 and 5000 µg/plate
Main study: 20, 39, 78, 156 and 313 µg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent/vehicle: A homogeneous suspension could be in DMSO and DMSO is accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3 -(5-nitro-2-furyl)acrylamide (AF-2)
- Remarks:
- without S9; 0.01 µg/plate in DMSO for TA100 and WPsuvrA; 0.1 µg/plate in DMSO for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9; 0.5 µg/plate in distilled water for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine·2HCl (ICR-191)
- Remarks:
- without S9; 1.0 µg/plate in DMSO for TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9; 5.0 µg/plate in DMSO for TA98, TA100 and TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- with S9; 2.0 µg/plate in DMSO for TA1535 and 10 µg/plate in DMSO for WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (pre-incubation method)
For the tests without metabolic activation, 0.5mL of 0.1 M Na-phosphate buffer (pH 7.4) and 0.1 mL of each fresh bacterial culture were added to each tube containing 0.1 mL of the test substance solution. For the tests with metabolic activation, 0.5mL of the S9 mix were added to each tube instead of the 0.1M Na-phosphate buffer. The mixture was pre-incubated in a water bath at 37°C for 20 minutes while shaking horizontally, and then 2.0 mL of top agar were added to the mixture, and the contents of each tube were poured over the surface of a minimal glucose agar plate.
DURATION
- Exposure duration: 20 minute pre-incubation + 48 hour incubation
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in duplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 2.6-5.7x10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- In the dose-finding test and the main test if the number of revertant colonies on the test plates increased significantly in comparison with that on the control plates (based on twice as many as that of the negative control), and a dose-response and reproducibility were also observed, the test substance was to be judged positive.
- Statistics:
- Statistical analysis was not done.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was observed at dose levels of 313 µg/plate and higher (with and without S9) in the dose range finder. In the main study precipitation was observed at 156 and 313 μg/plate without metabolic activation, and at 313 μg/plate with metabolic activation.
of
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- No toxicity or mutagenicity was observed up to and including the top dose of 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- No toxicity or mutagenicity was observed up to and including the top dose of 313 µg/plate
Applicant's summary and conclusion
- Conclusions:
- In an AMES test, performed according to Japanese guidelines for screening mutagenicity testing of chemicals, TISMO-D was found not to be mutagenic with or without metabolic activation.
- Executive summary:
An AMES test was performed according to Japanese guidelines for screening mutagenicity testing of chemicals and in accordance with GLP principles. All bacterial strains showed negative responses up to and including 5000 µg/plate in the dose-range finding test and up to and including 313 µg/plate in the main test, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was seen. No cytotoxicity of the test substance was observed. Precipitation was observed at dose levels of 313 µg/plate and higher (with and without S9) in the dose range finder and at 156 and 313 μg/plate without metabolic activation and at 313 μg/plate with metabolic activation in the main study. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that TISMO-D is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.
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