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Diss Factsheets
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EC number: 230-794-6 | CAS number: 7321-53-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Remarks:
- in vitro cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From May 22 to 31, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to accepted guideline but used in a weight of evidence approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ENV/JM/MONO(2010)20 – series of Testing and Assessment No. 129 – Guidance document on using cytotoxicity tests to estimate starting doses for acute oral systemic test.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Iron tris(2-ethylhexanoate)
- IUPAC Name:
- Iron tris(2-ethylhexanoate)
Constituent 1
Test animals
- Species:
- other: in vitro study
Administration / exposure
- Route of administration:
- other: in vitro study
- Vehicle:
- ethanol
Results and discussion
- Preliminary study:
- A preliminary dose-range finder experiment was undertaken in order to select appropriate dose levels for theMain Assay. In this experiment, the test item was assayed at a maximum dose level of 250 µg/mL and at a wide range of lower dose levels: 25.0, 2.50, 0.250, 0.0250, 0.00250, 0.000250 and 0.0000250 µg/mL. No precipitation of the test item was noted upon addition of the test item to the cultures at any concentration tested. Microscopic evaluation of cultures showed an increase in cell growth after treatment with the test item at 0.250, 2.50 and 25.0 µg/mL; at these concentrations a marked increase in neutral red uptake was
also observed. Reduction of the cell layer and change in cell morphology were noted at 250 µg/mL, where mild reduction in neutral red uptake was also seen. However, at this concentration, precipitation of the test item was observed by the end of treatment. After making the appropriate blank correction, mean values of absorbance, standard deviation and percentages over the solvent control values were calculated for each dilution of test item and positive control.
Effect levels
- Dose descriptor:
- other: IC50
- Remarks on result:
- other: not determinable due to precipitation of the compound at the highest dose levels
Any other information on results incl. tables
Solubility
Solubility of the test item was evaluated in a preliminary trial using ethanol (EtOH), which is the most appropriate solvent as indicated by the Sponsor. This solvent is known to be cytotoxic in the selected assay system at a concentration greater than 0.5% (volume fraction).
Based on this statement, ethanol has to be present at a constant volume equal to or lower than 0.5% (v/v) in the solvent/vehicle control and test item treatment media. A clear preparation was obtained in EtOH at the concentration of 200 mg/mL, after mixing with vortex. Solutions at 200 and 100 mg/mL, when added to Chemical DilutionMedium (CDM) in the ratio of 1:100, gave plenty precipitate. An opaque mixture with slight precipitate was obtained after addition of solution at 50.0 mg/mL to CDM. This suspension was considered suitable for treatment. Since solutions/suspensions in CDM should be added to DMEM culture medium in ratio 1:1, this result permitted a maximum final concentration of 250 µg/mL to be used in the preliminary dose-range finder experiment.
Main Assay
Based on the results obtained, in order to assay the test item at soluble concentrations, a Main Assay was performed using the following dose levels: 125, 50.0, 20.0, 8.00, 3.20, 1.28, 0.512 and 0.205 µg/mL; a smaller dilution factor was used in order to focus on the maximum practicable concentration. Moreover, in the preliminary experiment the mean OD value obtained for the solvent/vehicle control fell in the lower part of the historical distribution range for negative controls; therefore, in order to avoid toxicity due to the solvent, a reduced final percentage of solvent/vehicle was used for treatment. No precipitation of the test item was noted upon addition of the test item to the cultures at any concentration tested.
Treatment at concentrations between 0.512 and 20.0 µg/mLyielded an increased cell growth, as indicated by microscopic evaluation and neutral red uptake. Slight reduction of the cell layer compared to the negative control, was noted at 50.0 µg/mL, while reduction of the cell layer and change in cell morphology were noted at the highest dose level, where mild reduction in neutral red uptake was also seen. However, at this concentration precipitation of the test item was observed by the end of treatment. Optical density values of NR extract at 530 nm are presented in Table 2. After making the appropriate blank correction, mean values of absorbance, standard deviation and percentages over the solvent control values were calculated for each dilution of test item and positive control.
Negative control cultures gave acceptable optical density values (0.183 ≤OD530 NRU ≤ 0.769). Dose related toxicity was observed after treatment with the positive control, with a calculated IC50 value of 45.6 µg/mL, indicating the correct functioning of the assay system.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not cytotoxic under the reported experimental conditions
- Conclusions:
- The test item was not considered to be cytotoxic, under the reported experimental conditions. However, solubility is a limiting factor in achieving sufficient cytotoxicity for the calculation of the IC50 value.
- Executive summary:
Method
The potential in vitro cytotoxicity of the test item has been evaluated on Balb/c 3T3 cells. Cell cultures were treated with different concentrations of the test item. At the end of treatment time, measurement of neutral red uptake was performed to assess cytotoxicity and cell layers were examined in order to evaluate changes in cell morphology. Test item solutions were prepared using Ethanol.
A preliminary range-finder experiment was undertaken in order to select appropriate dose levels for the Main Assay. Based on the results obtained in a preliminary solubility trial, the test item was assayed at a maximum dose level of 250 µg/mL and at a wide range of lower dose levels: 25.0, 2.50, 0.250, 0.0250, 0.00250, 0.000250 and 0.0000250 µg/mL.
Observations
Reduction of the cell layer and change in cell morphology were noted at 250 µg/mL, where slight reduction in neutral red uptake was also observed. However, at this concentration precipitation of the test item was seen.
Since cytotoxicity should be evaluated at dose levels without visible precipitate, the Main Assay was performed using the following concentrations spaced by a factor of 2.5: 125, 50.0, 20.0, 8.00, 3.20, 1.28, 0.512 and 0.205 µg/mL. Precipitation of the test item was observed by the end of treatment at the highest dose level. Slight reduction of cell layer was noted at 50 µg/mL, while reduction of the cell layer and change in cell morphology were noted at 125 µg/mL. At these concentrations mild reduction in neutral red uptake was also observed.
Negative and positive control treatments were included in the Main Assay. Negative control cultures gave acceptable optical density values (0.183 ≤ OD≤ 0.769). Dose related toxicity was observed after treatment with the positive control, with a calculated IC50 value of 45.6 µg/mL, indicating the correct functioning of the assay system.
Conclusion
The test item was not considered to be cytotoxic, under the reported experimental conditions. However, solubility is a limiting factor in achieving sufficient cytotoxicity for the calculation of the IC50 value.
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