Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
2019-09-30 to 2019-10-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
column elution method
Key result
Water solubility:
<= 0.04 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 5.7 - <= 6.1

Results of the preliminary test

Amount of test
item / mg

Added volume of demineralized water /mL

Total volume of demineralized water /mL

Appearance of mixture

104.0

0.1

0.1

not dissolved

0.4

0.5

not dissolved

0.5

1.0

not dissolved

1.0

2

not dissolved

8.0

10

not dissolved

 

Three additional preliminary tests were carried out with specified amounts of the test item and 100 mL and 500 mL demineralized water, respectively. After each addition of an amount of water, the mixture was stirred for 24 hours, and visually checked for any undissolved particles.

 

Results of the preliminary test

Amount
of test item / mg

Total volume of demineralized water / mL

Appearance of mixture

10.2

100

not dissolved

12.4

500

not dissolved

2.0

500

not dissolved

The preliminary test showed that the water solubility of the test item was < 10 mg/L According to the preliminary test the water solubility was determined by the column elution method in the main test.

 

Column 1:

Rotation period of the fraction collector: 90 min per fraction

Duration of sampling: about 46 h (31 fractions)

 

Column elution method, column 1 (approximately 12.5 mL/h)

Fraction no.

V

/mL

pH

water solubility
/ µg/L

22

19.0

5.6

<37

23

19.0

5.8

<37

24

19.0

6.0

<37

25

19.0

5.7

<37

26

19.0

5.8

<37

The water solubility was found to be below the quantification limit of 37 µg/L.

Column 2:

Rotation period of the fraction collector: 45 min per fraction
Duration of sampling: about 46 h (62 fractions)

Column elution method, column 2 (approximately 25.0 mL/h)

Fraction no.

V

/mL

pH

water solubility
/ µg/L

50

18.0

5.8

<37

51

17.5

6.1

<37

52

17.5

5.9

<37

53

17.5

5.7

<37

54

17.5

5.8

<37

The water solubility was found to be below the quantification limit of 37 µg/L.

In both columns the concentration of five consecutive fractions was constant within + 30 %. No increasing or decreasing tendency was observed. The water solubility of the test item was below the quantification limit of 37 µg/L.

 

 

Conclusions:
The water solubility of the test item at a temperature of 20 °C was determined to be below 37 µg/L.
Executive summary:

The water solubility was determined according to OECD 105 using the column elution method with HPLC analysis. 103.1 mg of the test item were dissolved in 100 mL acetone. For charging the columns in each case 25 mL of the test item solution was added to about 3 g of sea sand and the mixtures were shaken. The solvent was then removed under reduced pressure using a rotary evaporator (40 °C, approx. 40 mbar). The dry residues were placed into the columns of the test apparatus, which have afterwards been filled with water (test temperature: 20 °C; water pH at 23 °C: 5.6). After a swelling time of 2 h pumps were started to rinse the test item coated sand with distilled water. The values for the water solubility were calculated from fractions 22 to 26 for the 12.5 mL/h column and from the fractions 50 to 54 for the 25.0 mL/h column. The water solubility was found to be below the quantification limit of 37 µg/L. Thus, the water solubility of the test item was determined to be below 0.04 mg/L at 20 °C.

Description of key information

The water solubility of the test item at a temperature of 20 °C was determined to be below 37 µg/L (reference 4.8 -1).

Key value for chemical safety assessment

Additional information

The water solubility was determined according to OECD 105 using the column elution method with HPLC analysis. 103.1 mg of the test item were dissolved in 100 mL acetone. For charging the columns in each case 25 mL of the test item solution was added to about 3 g of sea sand and the mixtures were shaken. The solvent was then removed under reduced pressure using a rotary evaporator (40 °C, approx. 40 mbar). The dry residues were placed into the columns of the test apparatus, which have afterwards been filled with water (test temperature: 20 °C; water pH at 23 °C: 5.6). After a swelling time of 2 h pumps were started to rinse the test item coated sand with distilled water. The values for the water solubility were calculated from fractions 22 to 26 for the 12.5 mL/h column and from the fractions 50 to 54 for the 25.0 mL/h column. The water solubility was found to be below the quantification limit of 37 µg/L. Thus, the water solubility of the test item was determined to be below 0.04 mg/L at 20 °C.