Registration Dossier

Diss Factsheets

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2018-03-20 to 2019-01-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
> 1 046 g/L
Conc. based on:
test mat.
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
7.1
Remarks on result:
completely miscible

Preliminary test

The preliminary test at room temperature showed, that the water solubility of the test item was estimated to be between 71.6 and 191.0 g/L. Therefore, the flask method was performed.

Table 2: Preliminary test for the water solubility

Amount of test item [mg]

Total volume of added water [mL]

Remark

114.57

0.1

not dissolved

0.6

not dissolved

1.6

dissolved

 

Main test

After 24, 48 and 72 h at 30 °C and further 24 h at 20 °C the test item was completely dissolved in the water, only one phase could be observed anymore.

About 10 mL of each flask were centrifuged for 30 minutes at 20 °C and 15000 rpm. After centrifugation also only one phase existed. No analytical determination of the concentrations was performed.

In the main test, about 104.6 g of the test item could be dissolved in 100 mL water (1046 g/L).

The additional tests with test item:water ratios of 10:90, 50:50 and 90:10 % (v/v) showed that the test item was completely mixed with water in all ratios at ambient temperature.

Conclusions:
The water solubility of the test item was determined to be above 1046 g/L at 20 °C. In the miscibility test it was determined that the test item is completely miscible at any ration with water.
Executive summary:

A study was conducted according to OECD TG 105 and Regulation (EC) No 440/2008 method A.6 to determine the water solubility of the test item. The preliminary water solubility of the test item was determined to be between 71.6 and 191.0 g/L. Based on these results the shake flask method was chosen for the main test. For the main test three flasks were prepared with an amount of test item and water, and one flask only with water. After 24, 48 and 72 h at 30 °C and further 24 h at 20 °C the test item was completely dissolved in the water, only one phase could be observed anymore. About 10 mL of each flask were centrifuged for 30 minutes at 20 °C and 15000 rpm. After centrifugation also only one phase existed. The additional tests with test item:water ratios of 10:90, 50:50 and 90:10 % (v/v) showed that the test item was completely mixed with water in all ratios at ambient temperature. The water solubility of the test item was stated to be >1046 g/L.

Description of key information

The water solubility of the test item was determined to be above 1046 g/L at 20 °C. In the miscibility test it was determined that the test item is completely miscible at any ration with water.

Key value for chemical safety assessment

Water solubility:
1 046 g/L
at the temperature of:
20 °C

Additional information

A study was conducted according to OECD TG 105 and Regulation (EC) No 440/2008 method A.6 to determine the water solubility of the test item. The preliminary water solubility of the test item was determined to be between 71.6 and 191.0 g/L. Based on these results the shake flask method was chosen for the main test. For the main test three flasks were prepared with an amount of test item and water, and one flask only with water. After 24, 48 and 72 h at 30 °C and further 24 h at 20 °C the test item was completely dissolved in the water, only one phase could be observed anymore.About 10 mL of each flask were centrifuged for 30 minutes at 20 °C and 15000 rpm. After centrifugation also only one phase existed.The additional tests with test item:water ratios of 10:90, 50:50 and 90:10 % (v/v) showed that the test item was completely mixed with water in all ratios at ambient temperature. The water solubility of the test item was stated to be >1046 g/L (reference 4.8-1).

Categories Display