Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.085 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.854 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.009 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
6.1 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.67 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.067 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.084 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Swarbrick 2004

A 96 hour acute toxicity to rainbow trout study was undertaken under static conditions using OECD Guideline 203. The analogue substance was tested at the following concentrations 7.5, 15, 30, 60 and 120 mg/L.

The substance was calculated to have an LC50 value after 96 hours of > 120 mg/L. The test item was determined to have a 96 hour NOEC value of 120 mg/L.

Jenkins 1997A 48 -hour acute toxicity toDaphnia magnastudy was conducted in accordance with US FDA Environmental Assessment Technical Assistance Handbook (March 1987) - Document 4.08 and, where possible, Procedure 202 ofthe OECD Guidelines (1984). The 48-hour median effect concentration (EC50) for immobility, based on measured concentrations of volatile free 1592U89 was found to be 119 mg/L (with 95% confidence limits of 60.6 and 251 mg/L).

Swarbrick 2004

A study to assess the toxicity of the test material to the green algaSelenastrum capricornutumaccording to OECD guideline 201, Alga, Growth Inhibition test.

Based on areas under the growth curve the results obtained at 72 hours were:

No observed effect (P=0.05) concentration (NOEC) = 30 mg/L

Median effective concentration, biomass (EbC50) = 57.4 mg/L (95% confidence limits = 56.9 - 57.8 mg/L)

Jenkins 1997

A study was carried out to assess the effects of 1592U89 on sewage micro-organisms by measuring the rate of oxygen uptake of activated sludge at 20° ± 2°C, in its presence at a range of concentrations. The methods employed were designed to meet the requirements of EC Directive 87/302, 'Biodegradation Activated Sludge Respiration Inhibition test' and OECD test guideline 209, 'Activated Sludge, Respiration Inhibition test'.

The test material is considered to be of low toxicity to activated sludge.

Conclusion on classification

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.

The lowest EC50was observed in the algal study and was ErC50= 85.4 mg/L.

Abacavir glutarate has a log Pow of 1.17, studies carried out on analogues of Abacavir Glutarate concluded that the substance cannot be considered to be readily biodegradable.

Based on the above information, Abacavir cannot be considered to be hazardous to the aquatic environment (acute/short-term) however based on criteria for chronic aquatic toxicity, the material can be considered to be hazardous to the aquatic environment (long-term).

In this case an EC50of >10 to<100 mg/L and the conclusion that the test material is not rapidly degradable means that a classification according to current guidelines, classifies the material as Aquatic Chronic Cat 3.