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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Remarks:
- in vitro cytotoxicity assay
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From January 10 to February 01, 2019
- Reliability:
- 2 (reliable with restrictions)
- 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:
- other: OECD Guidance document No. 129, "Guidance Document on using cytotoxicity test to estimate starting doses for accurate oral systemic toxicity tests".
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: in vitro basal cytotoxicity assay
- Limit test:
- no
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
Results and discussion
Effect levelsopen allclose all
- Dose descriptor:
- other: IC50
- Effect level:
- 1.647 other: µg/mL
- Based on:
- test mat.
- Remarks on result:
- other: mean value of two experimets
- Dose descriptor:
- LD50
- Remarks:
- for rats
- Effect level:
- 127 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: value extrapolated from mean IC50
Any other information on results incl. tables
PRELIMINARY TEST
The preliminary test was performed to determine the relevant concentration range at which cytotoxicity is obtained. The test item was dissolved in DMEM0at 200 mg/mL after 45 minutes of magnetic stirring. From that formulation, seven serial dilutions were prepared in DMEM0 with a geometric dilution factor of 10. Using a treatment volume of 50% (50 μL in 50μL of culture medium), the concentrations tested in this preliminary test were: 0.01, 0.1, 1, 10, 100, 1000, 10000 and 100000 µg/mL in DMEM0.
The following results were obtained after 48 hours incubation:
. the concentrations ≥ 10000 µg/mL were unreadable due to a strong coloration of the bottom of the wells (linked to the intrinsic coloration of the test item),
. a strong cytotoxicity associated with rounded cells and a decrease in cell viability (decrease in NRU) was noted at concentrations ≥ 10 µg/mL,
. test item was also suspected to be volatile since vehicle control neighboring the highest tested concentration were at 0% viability instead of 100%, as usual. It was therefore decided to add a plate sealer on the top of the plates after treatment of the test item and positive control in the main experiments.
These results were taken into account to select a more appropriate test item concentration range for the main tests.
MAIN TEST
First experiment
The test item was first dissolved in DMEM0at 2 mg/mL after 25 minutes of magnetic stirring and was then 10-fold diluted inDMEM0to reach the concentration of 0.2 mg/mL. From that formulation, seven serial dilutions were prepared in DMEM0 with a geometric dilution factor of 3.16. Using a treatment volume of 50% (50 μL in 50 μL of culture medium), the final concentrations tested in this main test were: 0.03, 0.1, 0.32, 1, 3.17, 10.01, 31.65 and 100 µg/mL in DMEM0.
All acceptance criteria were fulfilled. This test was therefore considered as valid.
The following results were obtained after 48 hours incubation:
. strong cytotoxicity associated with rounded cells and decrease in cell viability (decrease in NRU) were noted at concentrations ≥ 3.17 µg/mL,
. the calculated IC50was 1.502 µg/mL,
. the LD50was therefore estimatedto be 123 mg/kg.
Second experiment
The same test item concentrations as those used in the first experiment were selected for the treatment of the second experiment.
All acceptance criteria were fulfilled. This test was therefore considered as valid.Results of the microscopic observation of the plates treated with the test item are outlined in Table 3. A summary of the NRU results obtained for the test item, the vehicle and positive controls are outlined in Table 4. Individual results of these plates are presented in Appendix 2. The graphs obtained after the analysis with the GraphPad Prism from the test item and positive control-treated plates are presented in Figures 3 and 4, respectively.
The following results were obtained after 48 hours incubation:
. strong cytotoxicity associated with rounded cells and decrease in cell viability (decrease in NRU) were noted at concentrations ≥ 3.17µg/mL,
. the calculated IC50was 1.791 µg/mL,
. the LD50was therefore estimated to be 131 mg/kg.
Final interpretation
According to the results obtained in both experiments, the calculated mean IC50was 1.647 µg/mL. Therefore, based on the mean IC50, the mean estimated LD50in rats was 127 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 3 based on CLP criteria
- Conclusions:
- IC50 = 1.647 µg/mL
LD50 (estimated) = 127 mg/kg in rats - Executive summary:
Method
The objective of this study was to evaluate the basal cytotoxicity of the test item, using the 3T3 NRU test (Neutral Red Uptake). The design of the study is based on the OECD Guidance document No. 129 for "Guidance Document on using cytotoxicity test to estimate starting doses for accurate oral systemic toxicity tests". The NRU assay is performed in a dose-response format allowing the calculation of the concentration of the test item that reduces Neutral Red Uptake (NRU) by 50% (IC50). The IC50 value is used in a linear regression equation to estimate the oral LD50 value in rats. The assay evaluates the cytotoxicity of the test item applied to mouse fibroblasts (Balb/c 3T3, clone A 31).
Results
In both experiments, the tested concentrations were: 0.03, 0.1, 0.32, 1, 3.17, 10.01, 31.65 and 100 µg/mL in DMEM0. The following results were obtained after 48 hours incubation:
- strong cytotoxicity associated with rounded cells and decrease in cell viability (decrease in NRU) were noted at concentrations ≥ 3.17µg/mL,
- the calculated IC50 were 1.502 µg/mL and 1.791 µg/mL in the first and second experiments, respectively,
- these results correspond to estimated LD50 of 123 mg/kg and 131 mg/kg, in the first and second experiments, respectively.
Conclusion
Under the experimental conditions of this study and after treatment of cells for 48 hours, the test item, is considered as cytotoxic in this in vitro test system. The mean IC50 was estimated to be 1.647 µg/mL and the corresponding LD50 for rats was estimated to be 127 mg/kg according to OECD Guidance No. 129.
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