Registration Dossier

Physical & Chemical properties

Water solubility

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Description of key information

One reliable key study is available on the registered mixture. The experimental value of maximum water solubility have been determinated on the two main components of the test item to be 55.8 g/L for the monoester and 4.46 g/L for the diester at 20°C. The weighted average of both values to the composition rates have been calculated to be 30.05 g/L for the purposes of chemical risk assessment and classification and labelling.

Key value for chemical safety assessment

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

Additional information

The determination was carried out on the registered mixture using a flask method designed to be compatible with Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. The test is GLP compliant and the validity criteria's were fulfilled.

For the monoester components, there was no evidence of a saturation plateau and these components were continually extracted from the test item into aqueous solution. The diester components showed a more unusual relationship in that observed solubility was inversely proportional to the initial loading rate, such that the aqueous solution concentration decreased as the quantity of test item added to the test system increased. Therefore, based on the data generated from the investigation of loading rate, the overall result has been taken as the maximum observed solubility within the test as summarized below:

 

Monoester components, “as test item” concentration

Monoester components “definitive” concentration corrected for purity

Diester components, “as test item” concentration

Diester components “definitive” concentration corrected for purity

Maximum observed concentration (g/l)

55.8

28.0

4.46

2.09

Based on the weighted average with the composition rates of its two main components, a maximum water solubility of 30.05 g/L at 20°C was assessed for the registered mixture for chemical risk assessment and classification and labelling purposes.