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Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 5, 2021 to March 10, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline compliant study with GLP

Qualifier:

no guideline required

Principles of method if other than guideline:

The standard EC A.6 / OECD 105 methodology was not applicable to this test item due to its miscibility with water.

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Specific details on test material used for the study:

Appearance/Physical state:
solid (deliquescent)*

Batch:
209-653 (dried material from [Tradename] batch number 0001569403)

Purity:
~94.5%*

Expiry / Retest date:
03 December 2021

Storage conditions:
ambient temperature, in the dark, under nitrogen


*As the test item is a deliquescent solid and the samples used in this study were all viscous liquids, it indicates the solid had absorbed up to 10% water. The purity of the liquid samples was therefore 85.05%.

Key result

Conc. based on:

test mat.

Temp.:

20 °C

Remarks on result:

other: Visual assessment. Completely miscible in all proportions.

Details on results:

All samples had no undissolved test item observed.
Overall result: Miscible with water in all proportions at 20.0 ± 0.5 °C.

Table 2: Results

Sample	Concentration (% w/w)	Observations	Solution pH
1	95.0	Amber coloured, single phase, slightly viscous liquid	n/a
2	74.9	Amber coloured, single phase, mobile liquid	4.1
3	50.2	Pale amber coloured, single phase, mobile liquid	3.9
4	25.1	Straw coloured, single phase, mobile liquid	3.8
5	5.35	Colourless, hazy mobile liquid.	3.7

All samples had no undissolved test item observed.

Overall result: Miscible with water in all proportions at 20.0 ± 0.5 °C.

Conclusions:

Miscible with water in all proportions at 20.0 ± 0.5 °C.

Executive summary:

The determination of water solubility was carried out by visual assessment, using a modified flask method designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.

 

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 visually assessment. The presence of up to 10% absorbed moisture in the test item was considered not to significantly affect the water solubility test. Even if with no moisture content the test item is a solid, it is a deliquescent and a sample prepared at 95% w/w would absorb all of the 5% water.

 

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. According to OECD 105 preliminary study, estimated solubility is >1000 mg/L.