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:
Testing conducted between 16 May 2008 and 02 Sepetember 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
0 g/L
Conc. based on:
test mat.
Incubation duration:
24 h
Temp.:
20 °C
pH:
ca. 7.3

Preliminary test: The preliminary estimate of water solubility was 1.80 x 10-4 g/l.

Definitive test:

The mean peak heights relating to the standard and sample solutions are shown in the following table:

 Solution Mean Peak Height 
Standard 0.520 mg/l  2.694 
Standard 0.515 mg/l  2.6.20 
Matrix blank  None detected 
Sample 1A  0.513 
Sample 1B  0.530 
Sample 2A  0.694 
Sample 2B  0.672 
Sample 3A  0.523 
Sample 3B 0.517

The concentration (g/l) of test material in the sample solutions is shown in the follwoing table:

 Sample number Time shaken at ca. 30 deg C (hours)  Time equilibrated at 20 deg C (hours)  Concentration (g/l)  Solution pH 
24  24  2.03 x 10 -4  7.2 
48  24  2.66 x 10 -4  7.3 
72  24   2.03 x 10 -4  7.5 

Mean concentration: 2.24 x 10-4 g/l at 20.0 +/-0.5 deg C and range: 2.03 x 10-4 to 2.66 x 10-4 g/l

Validation: The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 1 mg/l. This was satisfactory with a correlation coefficient of 1.00 being obtained.

Discussion: The preliminary water solubility test indicated that the column elution method should have been performed as the solubility was less than 1 x 10-2 g/l. However, due to the physical nature of the test material, it was not possible to use this method; experience has shown that liquid test materials coated on to glass beads cause these beads to adhere together forming a plug within the column, preventing water circulation.

Conclusions:
The water solubility of the test material has been determined to be 2.24 x 10-4 g/l of solution at 20.0 ± 0.5°C
Executive summary:

The determination was carried out using the flask method, Method A6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The water solubility of the test material has been determined to be 2.24 x 10-4 g/l of solution at 20.0 ± 0.5°C.

Description of key information

The determination was carried out using the flask method, Method A6 of Commission Directive 92/69/EEC.

The water solubility of the test material has been determined to be 2.24 x 10-4 g/l of solution at 20.0 ± 0.5°C.

Key value for chemical safety assessment

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

Additional information