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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:
2016-02-29 to 2016-03-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Noack Laboratorien GmbH Käthe-Paulus-Str. 1 31157 Sarstedt Germany
Type of method:
flask method
Key result
Water solubility:
37.2 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
100 g/L
Incubation duration:
72 h
Temp.:
20 °C
pH:
6.7
Details on results:
Preliminary Test (non GLP): The determined solubility in double distilled water was in the range of 4.915 - 19.66 g/L. For the application dose for the definitive study, 100 g/L, as ca. the fivefold of the maximum solubility result, was used.
Check of the pH-Value: The pH-values were determined with the remaining test item mixtures in the original test vessels, which were kept constant at 20 ± 0.5 °C.

pH-Value of the Test Item Mixtures and Double Distilled Water (Control)

 

Test temperature
[°C]

Preincubation time [h]

 

Replicate

Measured

pH

Mean

value

 

20

24

1

6.826

6.7

2

6.479

48

1

6.623

2

6.974

72

1

6.682

2

6.825

Control

5.995

-

 

 

Water Solubility Results at 20 °C

 

Preincubation time [h]

Replicate

Test item [g/L]

concentration

Mean

24

1

36.4

37.1

2

37.9

48

1

36.8

37.2

2

37.5

72

1

36.4

37.3

2

38.3

Mean (24 – 72h)

 

 

37.2

Deviation

 

 

0.5

 

Conclusions:
The water solubility of the test item was determined to be 37.2 g/L at 20±0.2 °C.
Executive summary:

A study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The analytical method (HPLC-DAD, 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 water solubility of the test item was determined to be: 37.2 g/L (20 °C, pH 6.7).

Description of key information

The water solubility of the test item was determined to be 37.2 g/L at 20±0.2 °C.

Key value for chemical safety assessment

Water solubility:
37.2 g/L
at the temperature of:
20 °C

Additional information

A study was conducted according to OECD Guideline 105 for Testing of Chemicals (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The solubility of the test item was determined using the flask method at 20 ± 0.5 °C with pre-incubation at 30 ± 0.5 °C. The analytical method (HPLC-DAD, 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 water solubility of the test iem was determined to be: 37.2 g/L (20 °C, pH 6.7).