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Diss Factsheets

Physical & Chemical properties

Water solubility

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Link to relevant study record(s)

Description of key information

A water solubility study carried out on the reference substance (White & Mullee, 2007AG) gave a determination of 5.14 g/L of solution at 20.0 ± 0.5°C.

A second study carried out on an analogue substance (White & Woolley, 2007AH) gave a determination of 70.3 g/L of solution at 20.0 ± 0.5°C.

An additional study carried out on an analogue substance (Sydney, 1997) gave a determination as follows:

17.4 ± 0.4 g/L in pH 5.0 buffer

25.3 ± 0.2 g/L in pH 7.0 buffer

22.4 ± 1.1 g/L in pH 9.0 buffer

Key value for chemical safety assessment

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

Additional information

A water solubility study carried out on the reference substance (White & Mullee, 2007AG) gave a determination of 5.14 g/L of solution at 20.0 ± 0.5°C.

A second study carried out on an analogue substance (White & Woolley, 2007AH) gave a determination of 70.3 g/L of solution at 20.0 ± 0.5°C.

Both 2007 studies were conducted to the same standards and therefore considered to be reliable whilst the third study was conducted to US FDA Environmental Assessment guidelines. However as the first study (White & Mullee, 2007AG) was carried out

on the substance of interest this was considered to be the key study for the purposes of this assessment.

White & Mullee 2007:

This study was performed on Abacavir Glutarate.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 5.14 g/L of solution at 20.0 ± 0.5°C.

White & Woolley 2007: This study was performed on Abacavir Hemisulphate and has been used for read-across purposes.

The water solubility and partition coefficient ofthe test material have been determined using the flask method, Method A6 of Commission Directive 92/69/EEC.

The water solubility of the test material has been determined to be 70.3 g/L of solution at 20.0 ± 0.5°C.

Sydney 1997:

This study was performed on Abacavir Succinate and has been used for read-across purposes. The solubilities of the test material were determined by the flask shake method according to the US FDA Environmental Assessment Technical Assistance Handbook (March 1987).

The aqueous solubility of the test material at 20°C is:

17.4 ± 0.4 g/L in pH 5.0 buffer

25.3 ± 0.2 g/L in pH 7.0 buffer

22.4 ± 1.1 g/L in pH 9.0 buffer