Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.217 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:
0.14 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The required Predicted No Effect Concentrations (PNECs) for the different environmental compartments are calculated either by application of an assessment factor (PNECfreshwater, PNECmarine water, PNECintermittent release and PNECstp) or using the Equilibrium Partitioning Method (EPM; PNECsediment freshwater, PNEC sedimentmarinewater, PNECsoil).

The PNECair is not considered as relevant based on the chemical structure and intrinsic properties of the substance. Secondary poisoning of mammals and birds is not expected, thus the PNECoral is not derived. The utilized procedures are described in detail in ECHA REACH Guidance of May 2008 ("Guidance on information requirements and chemical safety assessment"), Chapter R.10 ("Characterisation of dose [concentration]-response for environment").

Conclusion on classification

Regarding all available data of the toxicity tests on aquatic organisms and taking into account the provisions laid down in EU Regulation 1272/2008 (CLP), the substance 2 -pyrrolidone does not have to be classified with respect to acute and chronic ecotoxicity.