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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30/03/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
GLP study performed using an accepted method
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:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
Appearance/Physical state: Yellow liquid
Batch: 1721964
Purity: 99.0%
Expiry date: 08 April 2016
Storage conditions: Room temperature, in the dark
Key result
Temp.:
20 °C
pH:
ca. 11.9
Remarks on result:
completely miscible
Details on results:
The highest saturation concentration prepared in the study was 95% w/w or 18.96 kg/L.

The standard A.6 Method was not applicable for this test item, due to the high indeterminable saturation levels produced in water. Therefore, the water solubility had to be estimated based on visual appraisal.The recorded observations for the contents of the flasks are:

Sample

Time shaken

at 30 ºC (h)

Time equilibrated

at 20 ºC (h)

Saturation conc.

(% w/w)

Solution pH

Observations

1

72

24

25.2

11.85

Very pale yellow, transparent, homogeneous solution. No visible excess of test item.

2

72

24

49.8

11.88

Pale yellow, transparent, homogeneous solution. No visible excess of test item.

3

72

24

75.0

12.05

Yellow, transparent, homogeneous solution. No visible excess of test item.

4

72

24

95.0

11.65

Yellow (slightly more intense colour), transparent, homogeneous solution. No visible excess of test item.

 

Conclusions:
The test item has been determined to be miscible with water in all proportions at 20.0 ± 0.5 °C. The highest saturation concentration prepared in the study was 95% w/w or 18.96 kg/L.
Executive summary:

A water solubility study on the test item determined it to be ‘miscible in all proportions’ at 20.0 ± 0.5 °C using the 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 highest saturation concentration prepared in the study was 95% w/w or 18.96 kg/L.

The standard A.6 Method was not applicable for this test item due to the high indeterminable saturation levels produced in water. Therefore, the water solubility had to be estimated based on visual appraisal.

Description of key information

A water solubility study on the test item determined it to be ‘miscible in all proportions’ at 20.0 ± 0.5 °C using the 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 highest saturation concentration prepared in the study was 95% w/w or 18.96 kg/L.

Key value for chemical safety assessment

Water solubility:
1 000 g/L
at the temperature of:
20 °C

Additional information

The standard A.6 Method was not applicable for this test item due to the high indeterminable saturation levels produced in water. Therefore, the water solubility had to be estimated based on visual appraisal.

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