Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.2 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
8 541 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
854 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:
2 518 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The analogue test item (EC 631-848-7) will not bioaccumulate due to its physico-chemical properties (Log kow > 9.4). Furthermore, the substance is readily biodegradable, so no chronic exposure of aquatic organisms is expected. Should the substance be taken up by fish, Fatty acid esters are metabolised into Fatty acids and alcohols. A QSAR calculation (BCFBAF v3.00) confirms the low bioaccumulation potential (77.7 L/kg regression based estimate).

Conclusion on classification

The analogue substance (EC 631-848-7) used for key studies is readily biodegradable and does not fulfil the criteria for classification as an acute or chronic aquatic hazard under the terms of Regulation (EC) No. 1272/2008. In accordance with the associated read-across justification, this conclusion is also considered to be applicable to the registered substance (EC 939-415-5).