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Water solubility

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water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-06-14 to 1999-08-07
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
The study was conducted according to an internationally recognised method, and under GLP. Purity and isomers composition are available from the notifier. However, the study shows several weaknesses. Therefore validation applies with restrictions.
Reason / purpose:
reference to other study
according to
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
UK GLP compliance programme (inspected on 23rd March 1998/ signed on 21st July 1998)
Type of method:
flask method
Specific details on test material used for the study:
Storage condition of test material: room temperature, in the dark, under nitrogen.
Key result
Water solubility:
0.012 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
500 mg/L
Incubation duration:
24 - 72 h
20 °C
5.6 - 6.1

Preliminary test

The preliminary estimate of water solubility was 1.5 x l0-2 g/L.

Definitive test

The mean peak areas relating to the standard and sample solutions are shown in the table below:

 Solution  Mean peak area
Standard 57.3 mg/L  5.390 x 104
Standard 55.5 mg/L  5.145 x 104
Sample lA  2.279 x 104
Sample 1B  2.775 X 104
Sample 2A  1.793 x 104
Sample 2B  2.810 x 104
Sample 3A   2.576 x 104
Sample 3B   3.008 x 104

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

 Sample number  Time shaken at ca 30°C (hours)  Time equilibrated at 20°C (hours)  Concentration (g/L)  Solution pH
 1 24 24 1.08 x 10-2  5.6 
 2 48 24 9.85 x 10-3  6.1 
 3 72 24  1.20 x 10-2 6.1 

Mean concentration: 1.09 x 10-2 g/L at 20.0 ± 0.5°C

Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
Executive summary:

The water solubility of the test substance was measured under GLP, according to EU A6 guideline, flask method.

Measurements were performed by GC analysis. The mean of consistent results at 24, 48 and 72h was retained.

The water solubility of the test substance was determined as 11.6 mg/L at 20°C.

Description of key information

Calculated from the major isomer.

The test substance is considered as slightly soluble.

Key value for chemical safety assessment

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

Additional information

A reliable experimental study, conducted according to a recognized EC method and under GLP, is available. Despite restrictions due to analytic weaknesses and surface-active potential, it is considered as a key study, and the result is retained as key value for purpose of CSA.