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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:
23-03-2018 to 29-03-2018
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
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
inspected: June 2016 ; signature: January 2017
Type of method:
flask method
Water solubility:
8.5 mg/L
Conc. based on:
test mat.
Incubation duration:
>= 94.83 - <= 123.63 h
Temp.:
20 °C
pH:
5.8
Remarks on result:
other: Mean of 94 h to 123 h incubation measurements ; duplicate vessels (n = 2) : deviation between replicate means was: 0.1%

Preliminary test

The determined solubility in double distilled water was 9.0 mg/L. For the application dose for the definitive study, 0.1 % (v/v) was used to facilitate the application procedure.

 

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 5.8: 8.5 mg/L.

 

Table 1.0. Water Solubility Results

Incubation time1)
[h]

Calculated Concentration2)
[mg/L]

 

Replicate 1

Replicate 2

 

94.83

8.55

8.24

96.86

8.74

8.86

99.03

8.23

8.46

119.60

8.14

8.43

121.60

8.59

8.17

123.63

8.80

8.82

Overall

Mean

8.51

8.50

8.50

Deviation [%]

8.1

8.5

0.1

1) = Time after application

2) = Exact weight of the external standard taken into account

 

Temperatures were kept constant within ± 0.5 °C. The determined solubilities for each preincubation time did not differ by more than 15 %. 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 substance water solubility was determined to be 8.5 mg/L of solution at pH 5.8 and 20.0 °C.
Executive summary:

The water solubility of the substance was determined according to the flask method: OECD Method 105 and EU Method A.6 under GLP. Determinations were conducted with preincubation at 20 ± 0.5 °C and a slow stirring rate without vortex, prior to sampling. Equilibration was shown to have occurred during the study. 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 of the substance was determined to be 8.5 mg/L of solution at pH 5.8 and 20.0 °C.

Description of key information

Water Solubility: 8.5 mg/L at pH 5.8 and 20 °C, OECD TG 105, 2018

Key value for chemical safety assessment

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

Additional information

Key study : EU Method A.6, 2018 : The water solubility of the substance was determined according to the flask method: OECD Method 105 and EU Method A.6 under GLP. Determinations were conducted with preincubation at 20 ± 0.5 °C and a slow stirring rate without vortex, prior to sampling. Equilibration was shown to have occurred during the study. 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 of the substance was determined to be 8.5 mg/L of solution at pH 5.8 and 20.0 °C.