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Environmental fate & pathways

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All studies were carried out on one of the analogue materials. The analogues are considered to be sufficiently similar to the substance of interest (please see attached data matrix and justification in Section 13 for additional details) for them to be used for the purposes of health and environment risk assessments.

Two studies have been carried out to assess the analogue materials Abacavir Succinate and Abacavir Hemisulphate for biodegradation in water:

Abacavir Succinate

Jenkins (1996):

Degradation of the test material was slow but progressive throughout the test; the mean cumulative CO2production was equivalent to 27% of the TCO2(range 25 to 29%) after 28 days.

The test material cannot therefore be considered to be ultimately degradable. The results of HPLC analysis at the end of the test suggests that the parent molecule may have been subject to primary degradation the extent of which ranged from 41% to 94%.

Abacavir Hemisulphate

Swarbrick & Smyth (2004): Analysis of the biotic exposure at the end of the 14 day test period showed mean degradation of equal to or >99%.

A study has been carried out to assess the analogue material Abacavir Succinate for biodegradation in soil:

Abacavir succinate did not readily undergo aerobic biodegradation in any of the soils examined with 15.3%, 16.8% and 11.4% of the applied test material recovered as carbon dioxide in the clay loam, sandy loam and sandy silt loam soils respectively.