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EC number: 935-977-0 | 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:
- 19.11.2008 - 11.02.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- no
- Type of method:
- column elution method
- Key result
- Water solubility:
- < 0.1 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- pH:
- 6.1
- Conclusions:
- The water solubility of the test substance was determined to be < 0.1 mg/L.
- Executive summary:
The water solubility of the test item was determined according to OECD 105 and Regulation (EC) No. 440/2008 method A.6 using the column elution method with HPLC analysis. 89.9 mg of the test item were dissolved in 100 mL acetone. 25 mL of this solution were added to about 3 g of sea-shore sand and the mixture was shaken. The solvent was then removed under reduced pressure using a rotary evaporator (50 °C, 50 mbar). The dry residues were placed into the columns of the test apparatus, which have afterwards been filled with water (test temperature: 20 °C; water pH at 24.2°C: 6.1). After a swelling time of 2 h the pump was started to rinse the substance coated sand with distilled water. Two identical samples were prepared, one of them was exposed to a flow rate of 12.5 mL/h (column 1), the other one to 25.0 mL/h (column 2). Another experiment was performed according to this procedure (flow rate 25.0 mL/h) but without test item ("blank" = column 3). The aqueous fractions were diluted 0.5 mL to 1 mL with methanol and measured by means of HPLC. The water solubility of the test item was determined to be <0.1 mg/L (<11.3 µg/L) at 20 °C (pH ~ 6.0).
Reference
Preliminary Visual Estimation of the Water Solubility
Amounts of the test item and water were stirred at room temperature until the mixture appeared dissolved or the water solubility could be estimated to be below 10 mg/L.
Table 1: Appearance of the test mixtures
Amount of the test item (mg) |
Total volume (mL) |
Appearance of mixture |
14.5 |
100 |
Undissolved* |
9.47 |
500 |
Undissolved** |
3.76 |
500 |
Undissolved** |
* After adding the indicated amount of water, the solution was treated with ultrasound for 30 minutes.
** After adding the indicated amount of water, the solution was stirred for two hours and ten minutes at room temperature.
The solubility of the test item in water is below 7.52 mg/L. Therefore the water solubility had to be determined by the “column elution method”.
Column elution method
Individual Conditions
Column 1:
Rotation period of the fraction accumulator: 90 min per fraction
Average fraction volume: 17.2 mL
Flow rate: between 11.3 mL/h and 11.7 mL/h
Duration of sampling: about 46.5 h (31 fractions)
Column 2:
Rotation period of the fraction accumulator: 45 min per fraction
Average fraction volume: 16.4 mL
Flow rate: between 21.3 mL/h and 22.0 mL/h
Duration of sampling: about 48 h (64 fractions)
Column 3 (blank):
Rotation period of the fraction accumulator: 45 min per fraction
Average fraction volume: 16.1 mL
Flow rate: between 20.7 mL/h and 22.0 mL/h
Duration of sampling: about 48 h (64 fractions)
Concentration and pH
Table 2. Column-elution method: Column 1
Fraction No. |
V in mL |
pH |
Water Solubility in µg/L |
Measured concentration in µg/L |
24 |
17.5 |
6.1 |
<11.3 |
<5.66 |
25 |
17.5 |
6.0 |
<11.3 |
<5.66 |
26 |
17.5 |
6.1 |
<11.3 |
<5.66 |
27 |
17.5 |
6.2 |
<11.3 |
<5.66 |
28 |
17.5 |
6.2 |
<11.3 |
<5.66 |
According to the guideline the run can be stopped if the concentration of five fractions do not differ more than ±30 % without raising or descending tendency. The content of test item in every fraction was below the detection limit.
Table 3. Column-elution method: Column 2
Fraction No. |
V in mL |
pH |
Water Solubility in µg/L |
Measured concentration in µg/L |
53 |
16.5 |
6.1 |
<11.3 |
<5.66 |
54 |
16.5 |
6.2 |
<11.3 |
<5.66 |
55 |
16.5 |
6.4 |
<11.3 |
<5.66 |
56 |
16.5 |
6.4 |
<11.3 |
<5.66 |
57 |
16.5 |
6.3 |
<11.3 |
<5.66 |
The content of test item in every fraction was below the detection limit.
Table 4. Column-elution method: Column 3 (blank)
Fraction No. |
V in mL |
pH |
Water Solubility in µg/L |
Measured concentration in µg/L |
53 |
16.5 |
6.0 |
<11.3 |
<5.66 |
54 |
16.5 |
6.0 |
<11.3 |
<5.66 |
55 |
16.5 |
6.1 |
<11.3 |
<5.66 |
56 |
16.5 |
6.0 |
<11.3 |
<5.66 |
57 |
16.5 |
5.9 |
<11.3 |
<5.66 |
According to the guideline, the data of the fractions 1 to 5 were not taken into account for the following evaluation. The values of the water solubility were calculated from fractions 24 to 28 for column 1, from the fractions 53 to 57 for column 2, from the fractions 53 to 57 for column 3.
A recovery of the ‘recheck samples’ was performed and the recovery was found to be between 98.3 % and 110.0 % for the single and mean values, indicating a good accuracy of the analytical method. The performed coating check was successful.
Result Column 1 and Column 2: The water solubility of the test item was determined to be <11.3 µg/L.
Result Column 3: The blank concentration was found to be <11.3 µg/L.
Description of key information
The water solubility of the test substance was determined to be < 0.1 mg/L.
Key value for chemical safety assessment
Additional information
The water solubility of the test item was determined according to OECD 105 and Regulation (EC) No. 440/2008 method A.6 using the column elution method with HPLC analysis. 89.9 mg of the test item were dissolved in 100 mL acetone. 25 mL of this solution were added to about 3 g of sea-shore sand and the mixture was shaken. The solvent was then removed under reduced pressure using a rotary evaporator (50 °C, 50 mbar). The dry residues were placed into the columns of the test apparatus, which have afterwards been filled with water (test temperature: 20 °C; water pH at 24.2°C: 6.1). After a swelling time of 2 h the pump was started to rinse the substance coated sand with distilled water. Two identical samples were prepared, one of them was exposed to a flow rate of 12.5 mL/h (column 1), the other one to 25.0 mL/h (column 2). Another experiment was performed according to this procedure (flow rate 25.0 mL/h) but without test item ("blank" = column 3). The aqueous fractions were diluted 0.5 mL to 1 mL with methanol and measured by means of HPLC. The water solubility of the test item was determined to be <0.1 mg/L (<11.3 µg/L) at 20 °C (pH ~ 6.0) (reference 4.8-1).
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