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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:
07-12-2006 to 11-01-2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.
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)
Remarks:
inspected: August 2005 ; signature: November 2005
Type of method:
flask method
Water solubility:
19 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
> 6 - < 7.3
Remarks on result:
other: The water solubility is the average of three determinations at 20.0 ± 0.5°C

Preliminary test:

The preliminary estimate of water solubility was 25.1 mg/L.

 

Definitive test:

The peak area relating to the standard and sample solutions were determined.

Table 1.0: Test item concentrations

Sample Number

Time shaken at 30°C (hours)

Time equilibrated at 20°C (hours)

Concentration (mg/L)

pH measured

1

24

24

21.2

7.3

2

48

43.5

18.7

6.2

3

72

43.5

17.2

6.0

 

 

 

 

 

Mean concentration: 19.0 mg/L at 20.0 ± 0.5°C

 

Analytical method validation:

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 25 mg/L. This was satisfactory with a correlation coefficient of 1.00 being obtained.

Conclusions:
Interpretation of results: slightly soluble (0.1-100 mg/L)
The test item water solubility was determined to be 19 mg/L at 20.0 ± 0.5°C and ca. pH 7.0.
Executive summary:

The water solubility of the substance was determined according to EU Method A.6 and OECD Method 105, flask method in accordance with GLP. Determinations with preincubation at 30 ± 0.5 °C with shaking for 24, 48 and 72 hours and then settling at 20 °C for 24 or 43.5 hours were conducted with subsequent analysis by HPLC DAD using the test item as an external standard. The concentration measured in at least the last two longest incubation times (48 and 72 h) differed by no more than 15% and the temperature was kept constant to within ± 0.5 °C. Under the conditions of this study, the mean water solubility of the test item was determined to be 19 mg/L at 20 ± 0.5 °C and at approximately pH 7.0.

Description of key information

Water Solubility: 19 mg/L at 20.0 ± 0.5°C and ca. pH 7.0, flask method – EU Method A.6, 2007

Key value for chemical safety assessment

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

Additional information

Key study : EU Method A.6, 2007 : The water solubility of the substance was determined according to EU Method A.6 and OECD Method 105, flask method in accordance with GLP. Determinations with preincubation at 30 ± 0.5 °C with shaking for 24, 48 and 72 hours and then settling at 20 °C for 24 or 43.5 hours were conducted with subsequent analysis by HPLC DAD using the test item as an external standard. The concentration measured in at least the last two longest incubation times (48 and 72 h) differed by no more than 15% and the temperature was kept constant to within ± 0.5 °C. Under the conditions of this study, the mean water solubility of the test item was determined to be 19 mg/L at 20 ± 0.5 °C and at approximately pH 7.0.