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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
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- Oxidation reduction potential
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- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 September 2017 - 03 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- column elution method
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical appearance: white powder with lumps
- Test item storage: at room temperature protected from light
Constituent 1
Results and discussion
Water solubility
- Key result
- Water solubility:
- < 0.002 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Temp.:
- 20 °C
- Remarks on result:
- other: Despite several flow rate switches from 24 mL/h to 12 mL/h and elution over a total period of 6 days, this is considered the best possible value to achieve for water solubility of the substance.
- Details on results:
- Mean concentration in the water samples (n=10) obtained at the flowrate of 24 mL/h was 0.000761 mg/L. CV= 44%.
Mean concentration in the water samples (n=10) obtained at the flowrate of 12 mL/h was 0.00165 mg/L. CV= 30%.
Overall mean concnetration: 0.00121 mg/L. Maximum difference = 74%.
The mean concentrations of the samples taken at a flow rate of 24 and 12 mL/h were 0.04 and 0.01 mg/L, respectively. Since the concentrations decreased at 12 mL/h, the flow rate was increased to 24 mL/h and sampling was repeated. The mean concentration of the repeated series was 0.002 mg/L. The turbidity of the eluates was >0.2 NTU which indicated the presence of undissolved material.
After 4 days of further elution at a flow rate of 3 mL/min, the flow rate was increased to 24 mL/h and ten samples were taken. Thereafter the flow rate was halved and ten samples were taken. The results for the samples of this test are summarized above. The coefficients of variation (CV) of the test samples (n=10) at a flow rate of 24 and 12 mL/h were 44 and 30%, respectively. The turbidity of the eluates was 0.6 NTU at both flow rates, which indicated the presence of undissolved material.
Since 0.5 µm frits were used and since elution was performed over a total period of 6 days, it is not considered possible to obtain a more accurate value for water solubility. Based on the mean concentrations at 24 mL/h and 12 mL/h, it was decided to report water solubility to be <0.002 mg/L.
The pH of the aqueous samples was 6.3 and 6.4.
Any other information on results incl. tables
Small responses were observed in chromatograms of the blank column at the retention time of the test item. The maximum contribution to the samples was 5.1% based on peak area. This is considered negligible.
Applicant's summary and conclusion
- Conclusions:
- The water solubility of the substance at 20°C was determined to be < 0.002 mg/L.
The pH of the aqueous samples was between 6.3 and 6.4. - Executive summary:
The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.
Quantification was performed by UPLC-MS/MS. Despite applying several flow rate switches from 24 to 12 mL/h and elution over a total period of 6 days, coefficients of variations of the tests were not <30%, and undissolved material was detected in the eluates (though 0.5 µm column end frits were used). Therefore, based on the mean measured concentrations at 24 mL/h and 12 mL/h, the water solubility at 20°C was concluded to be <0.002 mg/L.The pH of the aqueous samples was between 6.3 and 6.4.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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