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:
Study initiation date: 2 December 2009 Study completion date: 16 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted on 27 July 1995
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
Directive 92/69/EEC, Official Journal L 383 A 1992
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
45 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
233.3 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
2.4
Remarks on result:
other: Incubation at 30°C for the time given; afterwards equilibration at 20°C for 24 hours before determination of solubility
Details on results:
See below!

Details on measurements:

Sample
no

Amount of
test item
[g]

Added volume
of water
[ml]

Shaking time
at 30°C
[h]

Analysed carbon
concentration
[g C/L]

Concentration
of the test item
[g/L]1)

pH value2)

1

3.505

15

24

27.3

46.5

2.45

2

3.505

15

24

27.2

46.3

2.44

3

3.509

15

48

26.4

44.9

2.44

4

3.504

15

48

26.0

44.3

2.44

5

3.506

15

72

26.3

44.8

2.45

6

3.508

15

72

26.3

44.8

2.44

1) calculated from the carbon concentration of the sample solutions and the carbon content of the pure test item (58.75 %)

2) The purified water used for the tests had a pH value of 8.41.

Summay results for samples 1 to 6:

Arithmetic mean value: 45.3 g/L

SD: 0.90 g/L

Relative SD: 2.0%

Water solubility [g/L] specific to incubation time interval at 30°C:

24 h: 46.4

48 h: 44.6

72 h: 44.8

The relative standard deviation (repeatability) of the concentrations in all six samples was smaller than 15 % and the three duplicate sets of samples showed no tendency of increasing concentration

values. Thus the test was satisfactory.

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
Water Solubility (at 20°C): 45 g/I
Executive summary:

The water solubility of the test item was determined according to OECD guideline no. 105 [adopted on 27 July 1995] and EU test method A.6 [Directive 92/69/EEC, Official Journal L 383 A 1992] with the flask method. Water solubility (at 20°C): 45 g/l at a pH of 2.45.

The test(s) used to generate this report was (were) carried out in compliance with the principles of Good Laboratory Practice (GLP) in accordance with the currently valid German Chemical Substance Act (Chemikaliengesetz – ChemG), the underlying Commission Directive 2004/10/EC of 11 February 2004 and the relevant OECD decision of the council on 26 November 1997 and that the results fully reflect those found in the study.

Description of key information

Water solublity (OECD 105): 45 g/L at 20°C and a pH of 2.45

Key value for chemical safety assessment

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

Additional information

The water solubility of the test item was determined compliant with GLP according to OECD guideline no. 105 [adopted on 27 July 1995] and EU test method A.6 [Directive 92/69/EEC, Official Journal L 383 A 1992] with the flask method. Water solubility (at 20°C): 45 g/L at a pH of 2.45.