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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:
18 May 2016 to 21 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
Organization for Economic Co-operation and Development (OECD), OECD Guidelines for the Testing of Chemicals no. 105: "Water Solubility", July 27, 1995.
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
European Community (EC), EC no. 260/2014, Part A: Methods for the Determination of Physico-Chemical Properties, Guideline A.6: “Water Solubility”, Official Journal of the European Union no. L81, March 19, 2014.
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
United States Environmental Protection Agency (EPA), Product Properties Test Guidelines no. OPPTS 830.7840: "Water Solubility: Column Elution Method; Shake Flask Method", March 1998.
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method
Specific details on test material used for the study:
Test item: 207366/A
Identification: Lowinox® 22IB46
Appearance: White to cream coloured powder
Batch: WB44L0016
Purity/Composition: 99.7%
Test item storage: At room temperature
Stable under storage conditions until: 18 November 2018 (retest date)
Purity/composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Water solubility:
0.203 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 7.7 - <= 7.8
Details on results:
Preliminary test
The content of test item dissolved in the water sample was 0.0305 mg/L centrifuging once.
Centrifuging twice the concentration was 0.011 mg/L. This difference could have been caused by the presence of undissolved material upon one-fold centrifugation or by adsorption of the test item to the wall of the centrifugation tube. This was, however, considered acceptable: sufficient information was gathered to decide that the column elution method had to be carried out in the main study.

Main study
The coefficient of variation (CV) (n = 5 at 6 mL/h and n=10 at 12 mL/h) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at both flow rates. The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
The turbidity of the eluates was < 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.

Main study – water solubility of the test item

Flow rate

[mL/h]

Sample no.

Concentration analysed

pH

Individual

[mg/L]

Mean1

[mg/L]

CV

[%]

Mean2

[mg/L]

MD

[%]

12

1

2

3

4

5

6

7

8

9

10

0.217

0.198

0.205

0.205

0.207

0.209

0.209

0.221

0.221

0.225

0.212

4.0

 

 

7.8

6

1

2

3

4

5

0.169

0.199

0.200

0.201

0.206

0.195

7.5

0.203

8.2

7.7

1Mean of the concentrations obtained at one flow rate.

2Mean of the concentrations obtained at both flow rates.

Conclusions:
The water solubility of the test item at 20°C was 0.203 mg/L.
Executive summary:

The purpose of the study was to determine the physico-chemical properties for Lowinox® 22IB46

 

The column elution method was applied for the determination of the water solubility of LOWINOX® 22IB46 in accordance with the following guidelines:

European Community (EC), EC no. 260/2014, Part A: Methods for the Determination of Physico-Chemical Properties, Guideline A.6: “Water Solubility”, Official Journal of the European Union no. L81, March 19, 2014.

Organization for Economic Co-operation and Development (OECD), OECD Guidelines for the Testing of Chemicals no. 105: "Water Solubility", July 27, 1995.

United States Environmental Protection Agency (EPA), Product Properties Test Guidelines no. OPPTS 830.7840: "Water Solubility: Column Elution Method; Shake Flask Method", March 1998.

 

In the preliminary test the water solubility of the test item was < 10-2 g/L. Therefore, the column elution method was chosen for the main study.

 

The water solubility of the test item at 20°C was 0.203 mg/L.

 

The pH of the aqueous samples was 7.7 – 7.8.

Description of key information

Key value determined in a GLP accredited laboratory study using the column elution method in accordance with OECD Guideline 105, EU Method A6 and US EPA Procedure OPPTS 830.7840.

Key value for chemical safety assessment

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

Additional information

In the preliminary test the water solubility of the test item was < 10-2 g/L. Therefore, the column elution method was chosen for the main study.

 

The water solubility of the test item at 20°C was 0.203 mg/L.

 

The pH of the aqueous samples was 7.7 – 7.8.

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