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Description of key information

A hydrolysis study (White & Mullee - 2007) concluded that the reference material (Abacavir Glutarate) had an estimated half-life at 25°C as follows:

pH 4: Approximately > 1 year

pH 7:  > 1 year

pH 9:  > 1 year

An additional hydrolysis study (Sydney - 1997) concluded that the analogue material (Abacavir Succinate) is hydrolytically stable under acidic, neutral and basic conditions.

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
25 °C

Additional information

Two studies carried out to assess hydrolytic stability. The first study was carried out on the substance of interest however the second study was carried out on an analogue material. The analogue is considered to be sufficiently similar to the substance of interest (please see attached data matrix and justification in Section 13 for additional details) for it to be used for the purposes of health and environment risk assessments.

White & Mullee (2007)

The abiotic degradation, hydrolysis as a function of pH and adsorption coefficient of the test material have been determined.

Methods employed complied with those specified in Commission Directives 92/69/EEC and 2001/59/EC (which constitutes Annex V of Council Directive 67/548/EEC).

The estimated half-life was 25°C of the test material are as follows:

Table 0.1


Estimated half-life at 25°C


Approximately >1 year


>1 year


>1 year

Sydney (1997)

The hydrolysis of the test material as a function of pH was studied in accordance with US FDA Environmental Assessment, Technical Assistance Document 3.09 (FDA, March 1987) at pH 5.0, 7.0 and 9.0 and 50°C.

The preliminary study showed that after 5 days at pH 5.0, 7.0 and 9.0 and 50°C, less than 10% hydrolysis had occurred. This is equivalent to environmental half-lives (te1/2) of greater than one year at all three pH values.

No further testing was necessary, as this investigation indicated that the test material is hydrolytically stable under acidic, neutral and basic conditions.

Of the studies above, the most recent study (White & Mullee - 2007) was carried out on the substance of interest (Abacavir Glutarate) and is considered to be more reliable. Based on this conlusion, this study has been allocated as the key study of interest.