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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:
Testing was conducted between 15 June 2011 and 20 December 2011.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Qualifier:
equivalent or similar to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method
Key result
Water solubility:
>= 60 - <= 61.8 other: w/w
Temp.:
20 °C
pH:
>= 4.6 - <= 4.8
Remarks on result:
other: Visual assessment.
Details on results:
Please see section 'any other information on results incl. tables

Preliminary test

The sample concentrations and observations recorded are shown in the following table:

Sample
Identity

Loading Rate
(% w/w)

Observations

A

49.7

Clear pale orange liquid, no excess test item observed.

B

60.0

Clear pale orange liquid, no excess test item observed.

C

70.0

Excess undissolved test item observed.

D

80.0

Excess undissolved test item observed.

E

89.8

Excess undissolved test item observed.

Preliminary test result:      In the range of 60.0 to 70.0% w/w at 20.0 ± 0.5°C.

Definitive test

The sample concentrations and observations recorded are shown in the following table:

Sample
Identity

Loading Rate
(% w/w)

Observations

pH

1

61.8

Pale orange liquid with excess test item present.

4.6

2

63.7

Pale orange liquid with excess test item present.

4.6

3

65.9

Pale orange liquid with excess test item present.

4.6

4

68.0

Pale orange liquid with excess test item present.

4.7

5

70.0

Pale orange liquid with excess test item present.

4.7

6

71.9

Pale orange liquid with excess test item present.

4.8

Definitive test result:          Less than 61.8% w/w at 20.0 ± 0.5°C

Using the Preliminary and Definitive tests the water solubility was determined to be in the range of 60.0 to 61.8% w/w.

Conclusions:
The water solubility of the test item has been determined to be in the range of 60.0 to 61.8% w/w at 20.0 ± 0.5°C.
Executive summary:

Determination of water solubility was conducted using the flask method designed to be compatible with Method A6 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 water solubility of the test item has been determined to be in the range of 60.0 to 61.8% w/w at 20.0 ± 0.5°C.

Description of key information

The water solubility of the test item has been determined to be in the range of 60.0 to 61.8% w/w at 20.0 ± 0.5°C. For the purpose of chemical safety assessment, the maximum water solubility within the applicability domain of the environmental exposure model (ECHA Guidance on Information Requirements and Chemical Safety Assessment, R16) is used (100,000 mg/L).

Key value for chemical safety assessment

Water solubility:
100 000 mg/L
at the temperature of:
20 °C

Additional information

The standard A6 Method was not applicable to this test item due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection using the flask method (designed to be compatible with Method A6).

Definitive test

The sample concentrations and observations recorded are shown in the following table:

Sample
Identity

Loading Rate
(% w/w)

Observations

pH

1

61.8

Pale orange liquid with excess test item present.

4.6

2

63.7

Pale orange liquid with excess test item present.

4.6

3

65.9

Pale orange liquid with excess test item present.

4.6

4

68.0

Pale orange liquid with excess test item present.

4.7

5

70.0

Pale orange liquid with excess test item present.

4.7

6

71.9

Pale orange liquid with excess test item present.

4.8

Definitive test result:          Less than 61.8% w/w at 20.0 ± 0.5°C

Using the Preliminary and Definitive tests the water solubility was determined to be in the range of 60.0 to 61.8% w/w.