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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:
Nov 27 - Dec 05, 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
equivalent or similar to
Guideline:
EU Method A.6 (Water Solubility)
Principles of method if other than guideline:
Flask method with slow stirring
GLP compliance:
yes (incl. certificate)
Remarks:
Landesamt für Umwelt Rheinland-Pfalz
Type of method:
flask method
Water solubility:
<= 5.41 µg/L
Temp.:
20 °C
pH:
>= 6.05 - <= 6.34
Remarks on result:
other:
Remarks:
the mean at the plateau is stated as range < 0.2 – 5.41 μg/L

Validation Results

Determination of the test item concentrations in the samples was performed following validation report VB17052201G926.

All validation data are summarised in the following table:

Parameter

Value

Unit

Calibrated Range

0.1 – 1

μg/L

Linear term / Slope b

279901.094

counts*min /μg/L

Constant / Intercept a

-717.920

counts*min

Method Variation Coefficient (Precision)

8.98

%

Specificity

was given

-

Accuracy in demineralized water

##

%

Stability in demineralized water after 1 d (nominal 100 mg/L)

49

%

LOD / LOQ in calibration solvent

0.0108 / 0.0325

μg/L

LOD / LOQ in demineralized water#

0.0085 / 0.0255

μg/L

The concentration of the test item in solutions was determined during validation using the following equation:

Concentration [mg/L] = (Peak area - a) / b * sensitivity correction factor

Sensitivity correction factor was calculated from QC (quality control) samples.

Sensitivity correction factor = 100 % / QC recovery in %

Freshly prepared QC samples were injected regularly, and the QC recoveries were taken into account as sensitivity correction factors.

Results

The measurements of flasks 1C (day 8) and 2-6 were used for the calculation of the mean.

Flask

Concentration

[μg/L]

 

Total Mean

[μg/L]

 

Total Standard Deviation [g/L]

(Relative standard deviation RSD [%])

 

1C

0.34

1.07

2.14

(199)

2

0.22

3

< 0.22

4

< 0.22

5

5.41

6

0.45

On the final sampling day a high concentration range (with relative standard deviation 199%) was detected for the finally measured concentration: 1.07 ± 2.14 μg/L.

This high standard deviation may be due to high measurement uncertainty and to the difficulty to prepare mixtures with similar surface of the test item, which is in contact with the surrounding water and therefore important for the dissolution process. Therefore, the mean at the plateau is stated as < 0.2 – 5.41 μg/L (range of six individual vessels).

During this study the dependency of solubility of the nominal load was tested. No dependency on nominal load was detected.

No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.

Description of key information

The mean at the plateau is stated as range < 0.2 – 5.41 μg/L at 20°C and pH = 6.05 – 6.34 (OECD 105, flask method)

Key value for chemical safety assessment

at the temperature of:
20 °C

Additional information