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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-04-30 to 2012-05-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
other: preliminary estimate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: PFW100207
- Purity: contains 0.03% water
- Physical state: Liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in cool, well-ventilated area
Key result
Water solubility:
> 1 000 g/L
Temp.:
20 °C
Remarks on result:
other: During the aqeous solubility estimation stage of the test, the sample was found to be completely miscible with water in all proportions. The pH of the mixtures was not measured. Ambient temperature was not reported; 20 °C is anticipated.
Details on results:
Due to the infinite solubility observed, no further test was conducted. The aqueous solubility of the test substance was therefore estimated as infinite.

During the preliminary estimation it was found that the sample was completely miscible with water in all proportions, and therefore full water solubility test was not carried out.

5.2611 g of the test substance was weighed out and HPLC water was added at the following volumes: 0.5 mL, 1.0 mL, 1.5 mL, 2 mL, 5 mL, 10 mL and 20 mL. At each stage full dissolution was witnessed. These ratios run from concentrations of 10522.2 g of sample per litre of water, down to 263.055 g of sample per liter of water. It was concluded that the sample was completely miscible with water in all proportions. The same test was run starting with 5 mL of water and adding the sample from 0.5 mL to 20 mL, and the same results were observed. Sample is believed to be soluble in water at all concentrations.

Conclusions:
The substance is concluded to be miscible with water in all proportions at ambient temperature.

Description of key information

In a GLP study according to the preliminary test as specified in test method EC A.6, the test substance was determined to be miscible with water in all proportions under ambient conditions (Younis S, 2012).

Key value for chemical safety assessment

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

Additional information

The substance is miscible with water in all proportions. The bounded value of 100 g/L is used as the key value for chemical safety assessment, being the maximum value for water solubility as defined in the EUSES program.