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Diss Factsheets
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EC number: 947-350-9 | 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 6 March to 15 March, 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM - Recommended Test Method Protocol BALB/c 3T3 NRU Cytotoxicity Test Method
- Version / remarks:
- 2006
- Qualifier:
- according to guideline
- Guideline:
- other: ENV/JM/MONO(2010)20 – series of Testing and Assessment No. 129
- Version / remarks:
- 2010
- Principles of method if other than guideline:
- Test method under evaluation
- GLP compliance:
- yes
- Test type:
- other:
- Limit test:
- no
Test material
- Reference substance name:
- Reaction products of N-methyldiethanolamine and Boric Acid (1:1.5)
- EC Number:
- 947-350-9
- Molecular formula:
- N.A. (UVCB)
- IUPAC Name:
- Reaction products of N-methyldiethanolamine and Boric Acid (1:1.5)
- Test material form:
- liquid: viscous
Constituent 1
Administration / exposure
- Route of administration:
- other: in vitro method
Results and discussion
Effect levels
- Dose descriptor:
- other: IC50
- Effect level:
- 504 other: µg/mL
- Based on:
- other: cytotoxic effects to Balb/c 3T3 cells
Any other information on results incl. tables
Solubility
Solubility of the test item was evaluated in a preliminary trial using Chemical Dilution Medium. A clear solution was obtained at 200 mg/mL (250 mg/mL, test item as received).
Since solutions in this solvent should be added to DMEM culture medium in ratio 1:1, this result permitted a maximum concentration of 100 mg/mL to be used in the preliminary dose-range finder experiment.
Preliminary dose-range finder experiment
A preliminary range-finder experiment was undertaken in order to select appropriate dose levels for the Main Assay. In this experiment, the test item was assayed at a maximum dose level of 100000 μg/mL and at a wide range of lower dose levels: 0.010, 0.100, 1.00, 10.0, 100, 1000 and 10,000 μg/mL. No precipitation of the test item was observed by the end of treatment at any concentration tested. Dose related reduction of the cell layer was noted
starting from 1000 μg/mL; changes in cell morphology were observed at the three highest dose levels, where mild to severe reduction in neutral red uptake (NRU) was noted. The calculated IC50 value was 862 μg/mL.
Optical density values of NR extract at 530 nm are presented in Table 1 (in "Illustrations" in "Overal remarks, attachments"). 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.
The mean value of optical density, the standard deviation and the percentage over the solvent control value for each test point are presented in Table 1 (in "Illustrations" in "Overal remarks, attachments").
Main Assay
Based on the results obtained, the Main Assay was performed using the following concentrations: 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 10,000 μg/mL. No precipitation of the test item was noted at any dose level. Dose-related reduction of cell layer and change in cell morphology were noted at the four highest dose levels. Marked toxicity was observed at 10,000 and 3160 μg/mL, reducing NRU to 1 and 10% of the negative control, respectively.
Mild toxicity (NRU = 35 % of the negative control value) was observed at the next lower concentration of 1000 μg/mL, slight reduction in neutral red uptake was noted at 316 and 100 μg/mL (63 % and 68 %, respectively); while no relevant toxicity was observed at the remaining concentrations tested. The calculated IC50 value was 504 μg/mL.
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. The mean value of optical density, the standard deviation and the percentage over the solvent control value for each test point, together with the IC50 value and its variance are presented in Table 2.
Negative control cultures gave optical density values higher than the maximum acceptable value based on the range established by international community, but within RTC historical control range (OD530 NRU lower than 2.065).Dose related toxicity was observed after treatment with the positive control, with a calculated IC50 value of 45.2 μg/mL, coherent with the range established by the international scientific community, indicating the correct functioning of the assay system.
Analysis of results
In the preliminary dose-range finder experiment, the calculated IC50 value was 862 μg/mL. In the Main Assay, a narrow dose spacing was used in order to cover the relevant concentration range around the IC50 value, with several points of a graded effect. The calculated IC50 value was 504 μg/mL. On the basis of these results, it is concluded that the test item is cytotoxic under the reported experimental conditions.
Conclusion
The potential in vitro cytotoxicity of the test item was evaluated on Balb/c 3T3 cells. Negative and positive controls gave the expected results, indicating the correct functioning of the assay system. Dose-related toxicity was noted after treatment with the test item, with a calculated IC50 value of 504 μg/mL. It can therefore be concluded that the test item produced cytotoxic effects to Balb/c 3T3 cells, under the reported experimental conditions.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 for Acute Toxicity (300 < ATE ≤ 2000 mg/kg), according to the CLP Regulation (EC) No. 1272/2008
- Conclusions:
- The LD50 of the test item was calculated to be 457.3 mg/kg
- Executive summary:
The potential in vitro cytotoxicity of the test item was evaluated in an experimental study on Balb/c 3T3 cells, according to the ICCVAM Recommended Test Method Protocol BALC/C 3T3 NRU Cytotoxicity Test Method (2006) and the ENV/JM/MONO (2019)20 Series of Testing and Assessment No. 129 (2010). A preliminary range-finding test was performed on concentrations ranging from 0.01 µg/mL to 100 mg/L (based on results obtained from a preliminary solubility test) which found reduction in neutral red uptake (NRU), dose-related reduction of the cell layer and changes in cell morphology at concentrations of 1 mg/L and above. Based on the preliminary test results, the main assay was performed using concentrations of 3.16, 10, 31.6, 100, 316, 1000, 3160 and 10,000 µg/mL.
Negative and positive controls gave the expected results, indicating the correct functioning of the assay system. Marked toxicity was observed at the highest two doses: NRU was reduced to 1 % of the negative control at 10,000 µg/mL, and 10 % of the negative control at 3160 µg/mL. Mild toxicity was observed at the next lower concentration, slight reduction in NRU was noted at 316 µg/mL and 100 μg/mL (63% and 68%, respectively); no relevant toxicity was observed at the remaining concentrations tested. Therefore, based on these values, dose-related toxicity was noted after treatment with the test item, and the IC50 value was calculated to be 504 μg/mL. The acute toxicity estimate (ATE) was extrapolated using the following formula, provided in the ICCVAM Recommended Test Method Protocol BALC/C 3T3 NRU Cytotoxicity Test Method (2006), which predicts a corresponding median lethal dose (LD50) value:
log LD50 (mmol/kg) = 0.439 log IC50 (mM) + 0.621
where:
- IC50 = 504 µg/mL
- molecular weight of the test item = 207 g/mol
The corresponding log LD50 value was found to be 0.7926 mmol/kg, equivalent to LD50 value of 457.3 mg/kg.
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