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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 October 2018 (experimental starting date) - 06 November 2018 (experimental completion date)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
27 July 1995
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
30 May 2008
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Temp.:
20 °C
Remarks on result:
completely miscible
Details on results:
The standard EC A.6 / OECD 105 methodology was not applicable to this test item due to its miscibility with water. Therefore, a range of sample concentrations from a nominal 5 to 95% w/w were prepared for visual assessment. This had been assessed by preparing a mixture at approximately 50% w/w (Sample 1) and observing after manually shaking. The sample was a hazy, colourless single-phase liquid.
Although Samples 3 and 4 were hazy and Samples 4 and 5 had some particulates present, this was considered not to be undissolved test item. The test item, being a liquid, would have been expected to form two liquid layers with the water if they hadn’t mixed; this was not the case in any of the samples. Therefore, it was considered that the test item had dissolved and that an impurity was responsible for the haziness and particulates.Overall result: Miscible with water in all proportions at 20.0 ± 0.5 °C.
Conclusions:
The test item has been determined to be miscible with water in all proportions at 20.0 ± 0.5 °C
Executive summary:

The standard EC A.6 / OECD 105 methodology was not applicable to this test item due to its miscibility with water. Therefore, a range of sample concentrations from a nominal 5 to 95% w/w were prepared for visual assessment. This had been assessed by preparing a mixture at approximately 50% w/w (Sample 1) and observing after manually shaking. The sample was a hazy, colourless single-phase liquid.

Although Samples 3 and 4 were hazy and Samples 4 and 5 had some particulates present, this was considered not to be undissolved test item. The test item, being a liquid, would have been expected to form two liquid layers with the water if they hadn’t mixed; this was not the case in any of the samples. Therefore, it was considered that the test item had dissolved and that an impurity was responsible for the haziness and particulates.The test item has been determined to be miscible with water in all proportions at 20.0 ± 0.5 °C

Description of key information

The test item has been determined to be miscible with water in all proportions at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

Additional information

During the water solubility study, it was observed that dissolving the substance leads to a haze and cloudy solution. It is assumed that impurities might cause the haziness.

Additionally, it was observed that both in the water solubility study and in the partition coefficient study, the pH of the aqueous phase increased up to 10-11. This is caused by the amine function of the test substance. The high pH can lead to the hydrolysis of the amide group, which could also have caused the haziness of the solution.