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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:
From January 31 to October 01, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. No major deviation affected the quality of the study. The substance is considered to be adequately characterised. Therefore full validation applies.
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
excess amount in main test
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
excess amount in main test
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Compliance Programme (inspected on August 21, 2007/ signed on October 15, 2007)
Type of method:
flask method
Specific details on test material used for the study:
Storage condition of test material: Approximately 4 °C in the dark, under nitrogen.
Key result
Water solubility:
10.3 mg/L
Loading of aqueous phase:
0.67 g/L
Temp.:
20 °C
pH:
>= 6 - <= 6.6
Details on results:
Preliminary test: The preliminary estimate of water solubility was 7.66 mg/L
Definitive test: Mean concentration: 10.3 mg/L at 20.0 ± 0.5°C; Range: 10-10.5 mg/L

Table 4.8/1: Water solubility results

 

Sample number

Time shaken at ca. 30 °C (hours)

Time equilibrated at 20 °C (hours)

Concentration (g/L)

Solution pH

1*

24

24

8.12 x 10-3

6.6

2*

48

24

8.54 x 10-3

6.5

3

72

24

1.00 x 10-2

6.6

4

96

24

1.03 x 10-2

6.0

5

120

24

1.05 x 10-2

6.3

 

Mean concentration: 1.03 x 10-2g/L (10.3 mg/L) at 20.0 ± 0.5°C.

* not used in calculation of mean as samples considered not to have reached saturation.

Conclusions:
Interpretation of results: slightly soluble (0.1-100 mg/L)
Executive summary:

The water solubility of the test substance was measured under GLP according OECD 105 guideline and EU A6 guideline, flask method. Five measurements were performed at 24, 48, 72, 96 and 120 h, with duplicate analysis. Equilibrium was found to be reached from 72 h, and the mean result was retained.

The water solubility of the test substance is 10.3 mg/L at 20°C and pH ca 6.3.

Description of key information

Considered as slightly soluble, with equilibrium reached from 72h.
pH of saturated solution: 6.0-6.6

Key value for chemical safety assessment

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

Additional information

A fully reliable study, conducted according to a recognized OECD/EC method (flask) and under GLP, is available. Therefore it is considered as a key study. The result is retained as key data.