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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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 August 2019 - 13 August 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The determination of water solubility was performed using the slow stirring method adapted from OECD Guideline No 123, OECD Guideline No 105 and Method A.6. This study was considered as reliable without restrictions because it was conducted under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- other: adapted from OECD Guideline 123
- Deviations:
- no
- Principles of method if other than guideline:
- In a stirring vessel maintained at 20 +/- 0.5°C, ultra-pure water containing the test item poured into the top of the vessel was slow stirred. The stirring rate was adjusted in order to form a minimal vortex. The aim of this method was to prevent the formation of emulsions when saturating water. Emulsions can be formed with the shake flask method and lead to a solubility overestimation. The water solubility was given by the mass concentration of the substance in water when it reached a plateau as a function of time. Two experiments were performed in the same conditions
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2018-11-15
- Type of method:
- other: slow-stirring method
- Water solubility:
- 24.64 mg/L
- Temp.:
- 20 °C
- pH:
- >= 4.83 - <= 5.78
- Remarks on result:
- other: First determination (vessel 1)
- Water solubility:
- 24.69 mg/L
- Temp.:
- 20 °C
- pH:
- >= 4.74 - <= 5.78
- Remarks on result:
- other: Second determination (vessel 2)
- Key result
- Water solubility:
- ca. 24.67 mg/L
- Temp.:
- 20 °C
- pH:
- >= 4.74 - <= 5.78
- Remarks on result:
- other: Mean of two solubility values obtained in two different experiments.
- Conclusions:
- Based on two determinations with the slow-stirring method, the test item ST 08 C 19 solubility in water at 20 ± 0.5 °C was 24.67 mg/L.
- Executive summary:
A study was performed to assess the water solubility of the test item by the slow stirring method.
Two determinations in ultrapure water were carried out. 5 mL of the test item were carefully poured at the top of 250 mL of water thermostated at 20 + 0.5°C. The systems were allowed to equilibrate one day before starting the sampling and up to 8 days. The test item concentrations were monitored by HPLC-DAD.
The test item solubility in water at 20 ± 0.5 °C based on two determinations with the slow-stirring method was 24.67 mg/L.
Reference
Preliminary test
A preliminary test was carried out as a range finding test prior to the main test. The concentration range obtained gave an indication on the necessary analytical method sensitivity.
Increasing volumes of water were added at room temperature to 22.0 mg of the test sample in a 100 mL flask. After each addition of an amount of water, the mixture was shaken for 10 minutes and was visually checked for any undissolved parts of the sample.
The approximate solubility deduced from the necessary volume of water in which complete dissolution of the sample occurred is given in the table below.
Volume of water added | Solubilisation ? | Approximate solubility |
1 mL | NO | - |
10 mL | NO | - |
100 mL | NO | < 217 mg/L |
The test item (22.0 mg) was not solubilized by a water volume of 100 mL, corresponding to a solubility below 217 mg/L (taking into account the test item purity of 98.6 %).
Main test:
The following table presents the concentrations (in mg/L) obtained during the study for the two vessels. The sampling in the vessel 2 only started when the concentrations observed in the vessel 1 approached an equilibrium state.
Sampling date (m/d/y) | Vessel 1 | Vessel 2 |
08/05/19 8:15 (Preparation) | - | - |
08/07/19 8:00 | 24.91 | - |
08/07/19 13:15 | 23.60 | - |
08/08/19 8:10 | 24.67 | - |
08/08/19 13:20 | 24.26 | 24.47 |
08/09/19 7:55 | 24.48 | 24.63 |
08/09/19 13:10 | 24.76 | 23.79 |
08/12/19 8:35 | 25.83 | 25.88 |
08/12/19 13:35 | 24.04 | 24.29 |
08/13/19 7:45 | 24.11 | 24.85 |
These concentrations are presented as a function of time in the figure.
The pH values measured in both systems were:
- 5.78 in both systems at the beginning of the experiment.
- 4.83 in vessel 1 and 4.74 in vessel 2 at the end of the experiment.
The pH controlled with the indicator strips for each specimen was 5 for all the samples taken from the two vessels.
The temperature variations were included in the range 19.8 °C - 20.3 °C.
Equilibrium demonstration:
The equilibrium state was declared on August 13, at 7:45. The following table demonstrates that the equilibrium criteria are valid for each vessel.
Criteria | Vessel 1 | Vessel 2 |
Maximum difference observed in the 5 last samples | Min: 24.04 mg/L Max: 25.83 mg/L Difference: 7.2 % | Min: 23.79 mg/L Max: 25.88 mg/L Difference: 8.4 % |
Conclusion | Equilibrium reached | Equilibrium reached |
Water solubility calculation:
The means of the five samples before the equilibrium state declaration (08/13/2019 7:45) for each vessel are:
- 24.64 mg/L for vessel 1;
- 24.69 mg/L for vessel 2.
The difference observed between the two determinations is 0.20 %, which proves that an acceptable repeatability is obtained (the OECD 105 acceptability criterion for the maximum difference between two tests by the column elution method is 30 % and 15 % for the shake flask method).
The test item solubility in water is given by the mean of the values obtained for the two vessels: 24.67 mg/L.
Description of key information
Water Solubility: 24.64 mg/L at 20.0 ± 0.5 °C, EU Method A.6, 2020
Key value for chemical safety assessment
- Water solubility:
- 24.64 mg/L
- at the temperature of:
- 20 °C
Additional information
Kes Study :A study was performed to assess the water solubility of the test item by the slow stirring method.
Two determinations in ultrapure water were carried out. 5 mL of the test item were carefully poured at the top of 250 mL of water thermostated at 20 + 0.5°C. The systems were allowed to equilibrate one day before starting the sampling and up to 8 days. The test item concentrations were monitored by HPLC-DAD.
The test item solubility in water at 20 ± 0.5 °C based on two determinations with the slow-stirring method was 24.67 mg/L.
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