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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:
2016
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:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
Determination of the water solubility of the test item employing the flask method with slow stirring approach.The decision of the slow stirring method was made due to the test item properties. The test guideline was consistent with OECD Guideline 105 (water solubility) modified according to Letinski et al (2002) and OECD TG 123 (2006).
GLP compliance:
yes (incl. certificate)
Remarks:
inspected June 2013; signature: November 2013
Type of method:
flask method
Water solubility:
3.07 mg/L
Temp.:
20
pH:
6.1
Remarks on result:
other: Mean water solubility (n=2); 24 hours
Water solubility:
3.45 mg/L
Temp.:
20 °C
pH:
6.1
Remarks on result:
other: Mean water solubility (n=2); 48 hours
Water solubility:
3.12 mg/L
Temp.:
20 °C
pH:
6.1
Remarks on result:
other: Mean water solubility (n=1); 72 hours - note one outlier omitted following Grubbs-test
Water solubility:
3.21 mg/L
Temp.:
20 °C
pH:
6.1
Remarks on result:
other: Mean water solubility (n=5); 24 to 72 hours - note one outlier omitted following Grubbs-test; SD = 12.5%

Preliminary test:

Not applicable.

 

Definitive test:

The solubility of the test item in double distilled water was determined employing the flask method slow stirring approach at 20 ± 0.5 °C with preincubation at 30 ± 0.5 °C. The mean water solubility was respectively at pH 6.1:

3.21 mg/L

Temperatures were kept constant within ± 0.5 °C. The determined solubilities of the two test vessels did not differ by more than 15 %. The analytical method for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The test substance water solubility was determined to be 3.21 mg/L at pH 6.1 and 20.0 °C.
Executive summary:

The water solubility of the substance was determined according to OECD Method 105 and EU Method A.6 modified with slow stirring approach according to Letinski et al (2002) and OECD TG 123 (2006). Determinations with preincubation at 30 ± 0.5 °C and stirring rate of 100 rpm for 72 hours were conducted after a further 24 hours equilibration at 20 ± 0.5 °C. The analytical method (UPLC-MS/MS, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The mean water solubility of the substance was determined to be 3.21 mg/L at pH 6.1 and 20.0 °C.

Description of key information

Water Solubility: 3.21 mg/L; at pH 6.1 and 20 °C, OECD TG 105 slow stir method, 2016

Key value for chemical safety assessment

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

Additional information

Key data : EU Method A.6, 2016 : The water solubility of the substance was determined according to OECD Method 105 and EU Method A.6 modified with slow stirring approach according to Letinski et al (2002) and OECD 123 (2006). Determinations with preincubation at 30 ± 0.5 °C and stirring rate of 100 rpm for 72 hours were conducted after a further 24 hours equilibration at 20 ± 0.5 °C. The analytical method (UPLC-MS/MS, external standard) for the determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity. The mean water solubility of the substance was determined to be 3.21 mg/L at pH 6.1 and 20.0 °C.