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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:
From 27 September 2017 to 06 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to other study
Related information:
Composition 1
Reason / purpose:
reference to other study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Test material information:
Composition 1
Key result
Water solubility:
< 0.08 mg/L
Temp.:
20 °C
pH:
> 6.2 - < 6.3
Water solubility:
< 0.08 mg/L
Temp.:
20 °C
pH:
6.2
Water solubility:
< 0.08 mg/L
Temp.:
20 °C
pH:
6.3
Details on results:
In the preliminary test, the content of test item dissolved in the water sample was <10mg/l

The concentrations obtained in the main test were lower than the lowest concentration of the calibration curve. Therefore, the most accurate water solubility value was considered to be <0.08 mg/l (lowest calibration concentration taking into account the dilution factor of the test samples before quantification with the analytical method). The concentrations reported in the next table were obtained by extrapolation of the calibration curve, and were used to obtain an estimation of the test item water solubility.

 Flow rate (ml/h)  Sample N°  Concentration analysed per flow rate (mg/l)  Mean concentration analysed per flow rate(mg/l)  CV of concentration analysed per flow rate(%)  Mean concentration analysed (mg/l)  Maximum deviation (%)
 24                           

 0.036

 0.026                             23                             0.023                                                           31                                                         
 2

 0.016

 3  0.026
 4  0.024
 5  0.020
 6  0.027
 7  0.036
 8  0.026
 9  0.026
 10  0.028
 12                             1  0.021  0.019                             14                           
 2  0.022
 3  0.018
 4  0.022
 5  0.016
 6  0.017
 7  0.018
 8  0.024
 9  0.018
 10  0.018

The turbidity of the eluates was lower than 0.2 NTU. According to this, no undissolved particles were detected in the eluates. No test item was detected in the samples from the blank column.

Conclusions:
The water solubility of the test item is lower than 0.08 mg/l at 20°C and pH between 6.2 up to 6.3
Executive summary:

The water solubility of the test item was determined according to recognised guidelines and in compliance with GLP (Brekelmans, 2018). No deviation from the guideline was observed during the study.

Based on the results obtained in the preliminary test, the column elution method was used for the test item water solubility measurement.

The water solubility of the test item is lower than 0.08 mg/l at 20°C and pH between 6.2 up to 6.3

Description of key information

The water solubility of the test item was detemined in a key study of Klimisch validity 1 performed according to recognised guidelines and in compliance with GLP (Brekelmans, 2018).

No deviation from the guideline was observed in the study.

Key value for chemical safety assessment

Additional information

At 20°C, the test item water solubility is lower than 0.08 mg/l.

Indeed, in the key study main test, the concentrations obtained were lower than the lowest concentration of the calibration curve. Therefore, the most accurate water solubility value was considered to be <0.08 mg/l (lowest calibration concentration taking into account the dilution factor of the test samples before quantification with the analytical method).