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EC number: 234-293-3 | CAS number: 11071-15-1
- 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 / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16/12/2019
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test using the Hprt and xprt genes)
- Deviations:
- yes
- Remarks:
- These deviations did not influence the quality or integrity of the present study.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer
- EC Number:
- 234-293-3
- EC Name:
- Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer
- Cas Number:
- 11071-15-1
- Molecular formula:
- C8H4O12Sb2.2K
- IUPAC Name:
- (2R,3R)-2,3-dihydroxy-butanedioic acid, antimony potassium salt
- Details on test material:
- Batch No.: EM-19-33
Molecular Weight: 667.87 g/mol
pH at Room Temperature: 3.8 - 4.5 (in 2% water solution)
Physical State at RT: solid
Density: 2.6 g/cm3
Colour: colourless transparent crystals or white powder
Expiry Date: 25 March 2024
Storage Conditions: at room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other:
- Details on mammalian cell type (if applicable):
- V79 cells in vitro
- Metabolic activation:
- with and without
- Metabolic activation system:
- Name: DMBA; 7,12-dimethylbenz(a)anthracene
CAS: 57-97-6The V79 cells (ATCC, CCL-93) were stored over liquid nitrogen (vapour phase)
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 concentrations below:
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. The percentage of S9 mix in the final treatment medium was 5% (v/v). - Test concentrations with justification for top dose:
- with metabolic activation: 1.0, 2.5, 5.0, 10 and 20 μg/mL
without metabolic activation: 2.5, 5.0, 7.5, 10 and 15 μg/mL
The selection of the concentrations used in the main experiments was based on data from the pre-experiments according to the OECD guideline 476. - Vehicle / solvent:
- With metabolic activation: DMSO, dimethylsulfoxide
Without metabolic activation: Medium (MEM)
Controls
- True negative controls:
- other:
- Remarks:
- Negative controls (treatment medium, duplicate cultures) were treated in the same way as all concentration groups. Since treatment medium was used as appropriate solvent no additional solvent control was necessary
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Evaluation criteria:
- According to the OECD guideline, the biological relevance is considered first for the interpretation of results.
- Statistics:
- The non-parametric Mann-Whitney test was applied to the mutation data to prove the concentration groups for any significant difference in mutant frequency compared to the negative controls. Mutant frequencies of the negative controls were used as reference.
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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The main experiments were carried out without and with metabolic activation. The experiments with metabolic activation were performed by including liver microsomes and NADP for efficient detection of a wide variety of carcinogens requiring metabolic activation.
A biologically relevant growth inhibition (reduction of relative survival below 70%) was observed after the treatment with the test item in the experiment with and without metabolic activation. No induction of the mutant frequency was observed at this cytotoxic concentration.
All mean mutant values of the negative controls fall within the historical data range of the test facility and the cloning efficiencies of the negative and solvent controls are > 50%. The positive controls, DMBA (1.5 μg/mL) and EMS (300 μg/mL) showed statistically significant increases in mutant frequency, thereby demonstrating both the sensitivity and validity of the test systems.
Any other information on results incl. tables
Mutagenicity, without metabolic activation
Concentration [μg/mL] |
Mutant Frequency per 10^6 cells |
0 | 35.5 |
0 | 37.7 |
2.5 | 56.4 |
5.0 | 44.8 |
7.5 | 39.5 |
10 | 42.6 |
15 | 41.5 |
300 | 272.0 |
Main Experiment – Mutagenicity, with metabolic activation
Concentration [μg/mL] |
Mutant Frequency per 10^6 cells |
0 | 53.1 |
0 | 40.5 |
1.0 | 37.0 |
2.5 | 54.6 |
5.0 | 39.1 |
10 | 47.7 |
20 | 42.3 |
1.5 | 148.9 |
Applicant's summary and conclusion
- Conclusions:
- L(+) Antimony Potassium Tartrate is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.
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