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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:
2018
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)
Version / remarks:
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).
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
inspected: July 2016; signature: January 2017
Type of method:
flask method
Water solubility:
0.31 mg/L
Conc. based on:
test mat.
Incubation duration:
72 h
Temp.:
20 °C
pH:
6.4

Preliminary test:

The determined solubility in double distilled water was in the range of 0.388 mg/L.

 

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. The water solubility was respectively at pH 6.4:

Table 1.0. Water Solubility Results

Sampling

Incubation time (1) [hours]

Calculated Concentration (2)

[mg/L]

 

 

 

Replicate 1

Replicate 2

Overall Mean

1

72.33

0.309

0.270

 

2

74.33

0.306

0.286

 

3

76.33

0.293

0.315

 

4

96.33

0.327

0.330

 

5

98.33

0.333

0.318

 

6

100.33

0.308

0.318

 

 

Mean

0.313

0.307

0.310

 

Deviation [%]

14

22

1.9%

(between replicates)

(1) : time after application

(2) : Exact weight of the external standard taken into account

 

Temperatures were kept constant within ± 0.5 °C. The analytical method (GC 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.

Conclusions:
Interpretation of results: slightly soluble (0.1-100 mg/L)
The test item water solubility was determined to be 0.31 mg/L of solution at pH 6.4 and 20.0 ± 0.5 °C
Executive summary:

The water solubility of the test item was determined according to the slow stirring adapted flask method of OECD Method 105 and EU Method A.6 in accordance with GLP. The solubility of the test item in double distilled water was determined employing the flask method with slow stirring approach at 20 ± 0.5 °C with incubation at test temperature for 72 h before the first sampling. The analytical method (GC 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 (in double distilled water) of the test item was determined to be 0.31 mg/L at pH 6.4 and 20 °C.

Description of key information

Water Solubility (slow stir) = 0.31 mg/L at 20 ± 0.5 °C and pH 6.4, OECD TG 105, 2018

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was determined according to the slow stirring adapted flask method of OECD Method 105 and EU Method A.6 in accordance with GLP. The solubility of the test item in double distilled water was determined employing the flask method with slow stirring approach at 20 ± 0.5 °C with incubation at test temperature for 72 h before the first sampling. The analytical method (GC 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 (in double distilled water) of the test item was determined to be 0.31 mg/L at pH 6.4 and 20 °C.