Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.732 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:
13.364 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
23.1 mg/kg food
Assessment factor:
90

Additional information

No acute aquatic toxicity was seen at 100 mg/L towards fish, invertebrates or algae. Nevertheless, PNECs were derived for aquatic organisms as input for sediment and soil PNEC derivation according to the partitioning method.

Conclusion on classification

The substance is not acutely toxic to fish, daphnia and algae at nominal concentrations of 100 mg/L. Although the substance is poorly soluble in water, it is not readily biodegradable and LogPow calculation showed some potential to bioaccumulate (the values range from 6.85 to 24.17, all components above the safety threshold of 4), only one out of eight components has a calculated BCF above the threshold of concern in CLP regulation (500 L/Kg). This component is indeed Stearyl-diethanolamine, which is a residue of a starting product of the reaction, with a calculated BCF of 645.5 L/Kg. Other components, including all the esters generated in the reaction, have a BCF far below the threshold (10 to 100 times less).

Taking into account all this information, there are no real evidences of a possible concern for the aquatic compartment and thus the environmental classification is not needed according to CLP (Regulation EC No 1272/2008).