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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 March 2006 to 19 September 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Specific details on test material used for the study:
Date received: 5 September 2005
Description: amber coloured paste
Key result
Water solubility:
<= 0 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.1
Details on results:
The preliminary water solubility test indicated that the column elution method should have been performed as the solubility was less than 1x10-2 g/L. However, due to the physical nature of the test material (paste), it was not possible to use this method; experience has shown that liquid and viscous paste-like test materials coated onto glass beads cause these beads to adhere together forming a plug within the column and thus preventing water circulation.
The limit value used was calculated by using sample 2B. This was shown to be the worst-case sample. By perfom1ing a peak to peak baseline noise assessment between 5.25 to 5.75 minutes and multiplying the given value by two, a limit of detection was obtained. When corrected for dilution factor (0.005) and recovery, the limit of water solubility was calculated. The true water solubility of the lest material was probably much lower than this as baseline noise assessment always tends to favour a cautious estimate. The true solubility could be twenty to thirty limes lower than the calculated value.
The use of 400 mL samples, and re-dissolving in 2 mL was considered an appropriate compromise between detection and clarity. Processing larger samples, or dissolving in smaller volumes, although possible, could increase the risk of contamination and could also hinder the clean-up processes.
Under the conditions of the study, the water solubility of the test material was determined to be less than 4.54 x 10^-5 g/L of solution ± 0.5 ºC.
Conclusions:
Under the conditions of the study, the water solubility of the test material was determined to be less than 4.54 x 10^-5 g/L of solution at 20.0 ± 0.5 °C, using the flask method.
Executive summary:

A study was conducted to determine the water solubility of the test material. The study was conducted in accordance with the standardised guideline OECD 105 (flask method), under GLP conditions. The study is therefore a key study with a Klimsch score of 1.

Under the conditions of the study, the water solubility of the test material was determined to be less than 4.54 x 10-5g/L of solution at 20.0 ± 0.5 °C, using the flask method.

Description of key information

Under the conditions of the study, the water solubility of the test material was determined to be less than 4.54 x 10-5 g/L of solution at 20.0 ± 0.5 °C, using the flask method.

Key value for chemical safety assessment

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

Additional information

Key Study:

In a study conducted according to OECD Guideline 105 and conducted to GLP, the water solubility of the test material

was determined to be less than 4.54 x 10^-5 g/L of solution at 20.0 ± 0.5 °C, using the flask method (SafePharm Laboratories, 2006).