Registration Dossier

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:
07 August 2017 to 22 August 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Key result
Water solubility:
2.5 mg/L
Conc. based on:
test mat.
Incubation duration:
2 h
Temp.:
20 °C
pH:
6

Table 1: Summary of results

 

Flow rate (mL/h)

Solubility expressed as Gadolinium content in water

(mg/L)

Mean pH measured

Temperature (°C)

Test 1

25

2.2

6

20

Test 2

25

2.7

6

20

Mean Test 1 and Test 2

25

2.5

6

20

Test 3

12.5

2.4

6

20

Mean

12.5 and 25

2.5

6

20

Conclusions:
Under the conditions of this study the water solubility of the test material at 20 °C was 2.5 mg/L (pH 6).
Executive summary:

The water solubility of the test material was determined in accordance with the standardised guidelines OECD 105 and EU Method A.6 under GLP conditions.

In the preliminary test the solubility of the test material was < 0.01 g/L, therefore according to the guidelines the main test was to be performed with the column elution method.

The test material was mixed with water, sand (previously washed with ethyl acetate) was added to the mixture. The solution was stabilised for 2 h at 30 °C. The loaded support material and water was poured into the water-filled microcolumn and two hours were allowed for equilibrating. The microcolumn was connected to water using a recirculating pump at a flow rate of 25 mL/hour. Successive samples were taken and diluted. The amount of test material was determined through ICP-MS analysis.

Under the conditions of this study the water solubility of the test material at 20 °C was 2.5 mg/L (pH 6).

Description of key information

Under the conditions of this study the water solubility of the test material at 20 °C was 2.5 mg/L (pH 6).

Key value for chemical safety assessment

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

Additional information

The water solubility of the test material was determined in accordance with the standardised guidelines OECD 105 and EU Method A.6 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

In the preliminary test the solubility of the test material was < 0.01 g/L, therefore according to the guidelines the main test was to be performed with the column elution method.

The test material was mixed with water, sand (previously washed with ethyl acetate) was added to the mixture. The solution was stabilised for 2 h at 30 °C. The loaded support material and water was poured into the water-filled microcolumn and two hours were allowed for equilibrating. The microcolumn was connected to water using a recirculating pump at a flow rate of 25 mL/hour. Successive samples were taken and diluted. The amount of test material was determined through ICP-MS analysis.

Under the conditions of this study the water solubility of the test material at 20 °C was 2.5 mg/L (pH 6).