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EC number: - | CAS number: -
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:
- 29 June 2017 - 07 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- July 27, 1995
- Deviations:
- yes
- Remarks:
- The max difference between the results 24, 48 and 72 h stirred samples was not always ≤ 15%. The sample item was still turbid after centrifugation and filtration. None of the deviations were considered to have impacted the overall integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- March 19, 2014
- Deviations:
- yes
- Remarks:
- The max difference between the results 24, 48 and 72 h stirred samples was not always ≤ 15%. The sample item was still turbid after centrifugation and filtration. None of the deviations were considered to have impacted the overall integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- March 1998
- Deviations:
- yes
- Remarks:
- The max difference between the results 24, 48 and 72 h stirred samples was not always ≤ 15%. The sample item was still turbid after centrifugation and filtration. None of the deviations were considered to have impacted the overall integrity of the study.
- GLP compliance:
- yes
- Type of method:
- flask method
- Key result
- Water solubility:
- < 100 mg/L
- Conc. based on:
- test mat. (total fraction)
- Loading of aqueous phase:
- 100 mg/L
- Incubation duration:
- ca. 72 h
- Temp.:
- 20 °C
- pH:
- ca. 6.4
- Key result
- Water solubility:
- > 3 000 mg/L
- Conc. based on:
- other: The two main peaks
- Loading of aqueous phase:
- 3 000 mg/L
- Incubation duration:
- ca. 72 h
- Temp.:
- 20 °C
- pH:
- ca. 5.4
- Conclusions:
- The water solutibility of the test item was determined according to EC.A6, OECD Guideline No 105, EPA OPPTS 830.7840 and GLP principles.
The test was performed at 20°C by the flask method, the water solubility quantitification was based on the two major peaks in the chromatograms.
The solubility of the complete test item was <100 mg/L but maximum solubility for the two major peaks was not reached yet at a loading rate of 3000 mg/L - Executive summary:
The water solutibility of the test item was determined according to EC.A6, OECD Guideline No 105, EPA OPPTS 830.7840 and GLP principles.
The test was performed at 20°C by the flask method, and stirring the test item for 24, 48 and 72h.
A linear relationship between the nominal concentration and the mean results of the analysed concentration after two-times centrifugation and one filtration step based on peak 1 and peak 2 was observed. It proved that the maximum water solubility for peak 1 and peak 2 was not reached at nominal test item concentration of 3000 mg/L. Whereas, water solubility of the complete test item is <100 mg/L based on visual observation.
The pH of the aqueous samples was between 5.4 to 6.4.
Reference
Description of key information
The objective of the study was the determination of the water solubility of the test item.
The study was performed according to EC.A6, OECD Guideline No 105, EPA OPPTS 830.7840 and GLP principles, at at 20°C by the flask method, stirring the test items for 24, 48 and 72 h
For the highest loading concentrations, the centrifugation method was not found to be sufficient to remove all undissolved test item. Therefore all centrifuged samples were also filtered to remove any undissolved material
The water solubility quantitification was based on the two major peaks in the chromatograms.
The solubility of the complete test item was <100 mg/L but maximum solubility for the two major peaks was not reached yet at a loading rate of 3000 mg/L
Key value for chemical safety assessment
- Water solubility:
- 100 mg/L
- at the temperature of:
- 20 °C
Additional information
The solubility of the complete test item was <100 mg/L but maximum solubility for the two major peaks was not reached yet at a loading rate of 3000 mg/L
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