Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.009 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.024 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The experimental values for aquatic organisms exposed to N-(n-dodecyl) pyrrolidinone (LP-300) are consistently lower than the QSAR estimated values (see the table below). The table below shows the ecotoxicity test results obtained with Surfadone LP300 alongside QSAR generated results based on the neutral organic SAR and Amides from ECOSAR v1.11 and on the individual phys-chem data. The experimental value of long-term exposure of fish of 0.018 mg/L is almost equal to the predicted value of 0.015 mg/L. Further, fish appears to be the most sensitive of the three trophic levels. Hence this value of 0.018 mg/L is used to calculate the respective PNECs.

LP-300 acute E(L)C50      
  Species   Experimental ECOSAR Version 1.10 Results 
Neutral Organic SAR  Amides

Fish

0.59 3.13 2.68
Daphnia 0.139 2.14 1.160
Algae 0.053 3.46 0.13
  Chronic Value
  Experimental Neutral Organic SAR  Amides
Fish 0.018 0.381 0.015
Daphnia 0.046* 0.352 0.248
Algae 0.046 1.38 0.288

* Based on acute data.

Conclusion on classification