Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.378 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:
0.757 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.17 mg/kg food
Assessment factor:
300

Additional information

All the reported PNECs were calculated from the application of assessment factors as detailed from the Guidance on information requirements and chemical safety assessment Chapter R.10 Characterisation of dose (concentration)-response for environment.

The FND Amides chemicals have surfactant properties and should be considered to be toxic to aquatic species under conditions that allow contact of the chemicals with the organisms. This toxicity is common not only to the FND Amides chemicals but also to the FND Amines, Cationics, and Nitriles Categories. Further, the high toxicity is consistent with that of a large body of surfactants (e.g. alcohol ethoxylates, alkylphenol ethoxylates, sodium lauryl sulfate, and others).

EC/NOEC value of 0.25 mg/L from the algal study is taken as starting point for PNECs calculation.

For the calculation of PNEC secondary poisoning, the value (rounded value) of NAEL = 35 mg/kg/day (28 -days study LOAEL = 100 mg/kg/day) is taken as starting point (conversion factor NOAEL to NOEC = 10).

Conclusion on classification

According to Regulation (EC) N. 1272/2008, the substance is classified as very toxic to aquatic life with long lasting effects (Aquatic Chronic 1, H410).