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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
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- Auto flammability
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Endpoint summary
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- 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
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- Biotransformation and kinetics
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- 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:
- From January 10 to February 18, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [(2-hydroxyacetyl)oxy](oxo) vanadium 2-hydroxyacetate]
- IUPAC Name:
- [(2-hydroxyacetyl)oxy](oxo) vanadium 2-hydroxyacetate]
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- Histidine operon for typhimurium strains and tryptophan operon for E. Coli
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction
- Test concentrations with justification for top dose:
- Experiments without S9 mix
The selected dose levels were:
- 2.06, 6.17, 18.5, 55.6, 167 and 500 µg/plate for the TA 1535 and TA 100 strains in the first experiment,
- 0.686, 2.06, 6.17, 18.5, 55.6 and 167 µg/plate for the TA 1537 and TA 98 strains in the first experiment,
- 6.25, 12.5, 25, 50, 100 and 200 µg/plate for the TA 100 strain in the second experiment,
- 3.13, 6.25, 12.5, 25, 50 and 100 µg/plate for the TA 1535, TA 1537 and TA 98 strains in the second experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the WP2 uvrA strain in both experiments.
Experiments with S9 mix
The selected dose levels were:
- 2.06, 6.17, 18.5, 55.6, 167 and 500 µg/plate for the TA 1535 and TA 100 strains in the first experiment,
- 0.686, 2.06, 6.17, 18.5, 55.6 and 167 µg/plate for the TA 1537 and TA 98 strains in the first experiment,
- 2.57, 7.72, 23.1, 69.4, 208 and 625 µg/plate for the TA1535, TA1537, TA 98 and TA 100 strains in the second experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the WP2 uvrA strain in both experiments.
The selection of the highest dose level to be used in the main experiments was based on the level of toxicity - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injection
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Anthramine
- Remarks:
- With S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation in the first experiment and preincubation in the second
- Cell density at seeding (if applicable):
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 to 72 hours of incubation at 37°C
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
DETERMINATION OF CYTOTOXICITY
- Method: count of the number of revertant colonies associated observation on bacterial lawn
- Evaluation criteria:
- In all cases, biological relevance (such as reproducibility and reference to historical data) was taken into consideration when evaluating the results.
The test item is considered to have shown mutagenic activity in this study if:
- a reproducible 2-fold increase (for the TA 98, TA 100 and WP2 uvrA strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the mean number of revertants compared with the vehicle controls is observed, in any strain, at any dose level,
- and/or a reproducible dose-response relationship is evidenced.
The test item is considered to have shown no mutagenic activity in this study if:
- neither an increase in the mean number of revertants, reaching 2-fold (for the TA 98, TA 100 and WP2 uvrA strains) or 3-fold (for the TA 1535 and TA 1537 strains) the vehicle controls value, is observed at any of the tested dose levels,
- nor any evidence of a dose-response relationship is noted.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the upper dose tested
- 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:
- cytotoxicity
- Remarks:
- at the upper dose tested
- 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:
- cytotoxicity
- Remarks:
- at the upper dose tested
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the upper dose tested
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic
- Executive summary:
Method
The mutagenic effect of the test item was assessed according to the method descibed in the OECD guideline 471. A preliminary toxicity test was performed to define the dose levels of the test item, dissolved in water for injections, to be used for the mutagenicity experiments. The test item was then tested in two independent experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Treatments were performed according to the direct plate incorporation method, except for the second experiment with S9 mix, which was performed according to the pre-incubation method (60 minutes, 37°C).
Four strains of bacteria Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and one strain of Escherichia coli (WP2 uvrA) were used. Each strain was exposed to at least five dose levels of the test item (three plates/dose level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
Results
The test item was freely dissolved in the vehicle (water for injections) at 50 mg/mL, after a minimum of 30 minutes of magnetic stirring. Since the test item was toxic in the preliminary test, the selection of the highest dose level to be used in the main experiments was based on the level of toxicity, according to the criteria specified in the international guidelines.
The mean number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were at least five analysable dose levels (i.e.including at least three non-cytotoxic dose levels) for each strain and test condition. The study was therefore considered to be valid.
Experiments without S9 mix
The selected dose levels were:
- 2.06, 6.17, 18.5, 55.6, 167 and 500µg/plate for the TA 1535 and TA 100 strains in the first experiment,
- 0.686, 2.06, 6.17, 18.5, 55.6 and 167µg/plate for the TA 1537 and TA 98 strains in the first experiment,
- 6.25, 12.5, 25, 50, 100 and 200 µg/plate for the TA 100 strain in the second experiment,
- 3.13, 6.25, 12.5, 25, 50 and 100µg/plate for the TA 1535, TA 1537 and TA 98 strains in the second experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the WP2 uvrA strain in both experiments.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose levels.
A strong toxicity was noted at dose levels >= 50 µg/plate in the TA 1537 and TA 98 strains, >= 55.6 µg/plate in the TA 1535 strain and >= 167 µg/plate in the TA 100 strain.
No noteworthy toxicity was noted in the WP2 uvrA strainat any of the tested dose levels.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment. These results met the criteria of a negative response.
Experiments with S9 mix
The selected dose levels were:
- 2.06, 6.17, 18.5, 55.6, 167 and 500µg/plate for the TA 1535 and TA 100 strains in the first experiment,
- 0.686, 2.06, 6.17, 18.5, 55.6 and 167µg/plate for the TA 1537 and TA 98 strains in the first experiment,
- 2.57, 7.72, 23.1, 69.4, 208 and 625µg/plate for the TA1535, TA1537, TA 98 and TA 100 strains in the second experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the WP2 uvrA strain in both experiments.
No precipitate was observed in the Petri plates when scoring the revertants at any of the tested dose levels.
A strong toxicity was noted at dose levels >= 69.4 µg/plate in the TA 1537 strain, >= 167 µg/plate in the TA 98 strain, >= 208 µg/plate in the TA 1535 strain and >= 500 µg/plate in the TA 100 strain.
No noteworthy toxicity was noted in the WP2 uvrA strainat any of the tested dose levels.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains, in either experiment. These results met the criteria of a negative response.
Conclusion
Under the experimental conditions of this study, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli strains, either in the presence or absence of a rat liver metabolizing system.
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