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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:
29 April 2015 to 2 September 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to EU, OECD and EPA test guidelines to a GLP recognised standard
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
See below under "principles of method if other than guideline"
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
See below under "principles of method if other than guideline"
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
yes
Remarks:
See below under "principles of method if other than guideline"
Principles of method if other than guideline:
Maximum difference of the mean water solubility at the two flow rates of the column elution method was 50% and did not meet the criterion of ≤30%. The mean water solubility at the high and low flow rate was 1.9 and 1.1 μg/l respectively. These values are comparable and therefore water solubility is reported as the mean of these values. Improvement of the method is considered not possible.
The study integrity was not adversely affected by this deviation.
GLP compliance:
yes
Type of method:
column elution method
Water solubility:
1.5 µg/L
Temp.:
20 °C
pH:
7.7 - 7.8

Preliminary Test

The content of the test substance dissolved in the water sample was ≤15.9 µg/L

Main Study

The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system had equilibrated at these flow rates.

The maximum difference (MD) on the mean values of the samples at both flow rates was > 30%. The mean water solubility at the high and low flow rate was 1.9 and 1.1 μg/l respectively. These values are comparable and therefore water solubility is reported as the mean of these values. Improvement of the method is considered not possible.

The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.

No test substance was detected in the samples from the blank column.

Main study - water solubility of the test substance

Flow rate (mL/h)

Sample no.

Concentration analysed

pH

Individual (μg/l)

Mean (μg/l)1

CV (%)

Mean (μg/l)2

MD (%)

24

1

1.81

1.86

10

1.49

50

7.7

 

2

1.86

 

 

 

 

 

 

3

1.64

 

 

 

 

 

 

4

1.53

 

 

 

 

 

 

5

2.10

 

 

 

 

 

 

6

1.82

 

 

 

 

 

 

7

2.03

 

 

 

 

 

 

8

2.05

 

 

 

 

 

 

9

2.05

 

 

 

 

 

 

10

1.75

 

 

 

 

 

 

 

 

 

 

 

 

 

12

1

0.974

1.12

27

 

 

7.8

 

2

1.07

 

 

 

 

 

 

3

0.623

 

 

 

 

 

 

4

1.33

 

 

 

 

 

 

5

1.40

 

 

 

 

 

 

6

0.769

 

 

 

 

 

 

7

1.28

 

 

 

 

 

 

8

0.830

 

 

 

 

 

 

9

1.49

 

 

 

 

 

 

10

1.38

 

 

 

 

 

1Mean of the concentrations obtained at one flow rate.

2Mean of the concentrations obtained at both flow rates.

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The column elution method was applied for the determination of the water solubility of (1,2-Dioxoethylen)bis(iminoethylen)bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionat].
The water solubility of the test substance at 20°C was 1.5 μg/l.
The pH of the aqueous samples was 7.7 – 7.8
Executive summary:

The objective of this study was to determine the water solubility of the test substance. the water solubility was determined using the column elution method in accordance with:

European Community (EC), EC no. 440/2008, Part A: Methods for the Determination of Physico- Chemical Properties, Guideline A.6: “Water Solubility”, Official Journal of the European Union no. L142, May 31, 2008.

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 conclusion the water solubility of the test substance at 20°C was 1.5 μg/l. indicating the substance is insoluble

Description of key information

The column elution method was applied for the determination of the water solubility of (1,2-

Dioxoethylen)bis(iminoethylen)bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionat].

The water solubility of the test substance at 20°C was 1.5 μg/l. The pH of the aqueous samples was 7.7 – 7.8. Study concluded that the test

substance is insoluble.

Key value for chemical safety assessment

Water solubility:
1.5 µg/L
at the temperature of:
20 °C

Additional information

The objective of this study was to determine the water solubility of the test substance. the water solubility was determined using the column elution method according to:

European Community (EC), EC no. 440/2008, Part A: Methods for the Determination of Physico- Chemical Properties, Guideline A.6: “Water Solubility”, Official Journal of the European Union no. L142, May 31, 2008.

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 conclusion the water solubility of the test substance at 20°C was 1.5 μg/l. indicating the substance is insoluble