Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.045 mg/L
Assessment factor:
1 000

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
3 373 mg/L
Assessment factor:
1

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.22 mg/kg sediment dw

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.02 mg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.017 mg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Evaluating the short-term L(E)C50 values for n-Vinylpyrrolidone (nVP), those for fish and algae largely exceed the limit of 100 mg/L. For Daphnia only, an EC50 of < 100 mg/L was found: 45 mg/L. Further, nVP is readily biodegradable and long-term testing in Daphnia is waived. Substances that rapidly degrade can be quickly removed from the environment. While effects of such substances can occur, particularly in the event of an accidental spillage, they are localised and of short duration. According to Annex IX Column 2 of Regulation (EC) No 1907/2006, long-term toxicity testing is to be proposed if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms.  The hazard assessment of nVP reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.



Conclusion on classification

n-Vinylpyrrolidone (nVP) is not classified as hazardous to the aquatic environment according to the criteria laid out in Regulation (EC) 1272/2008 or in Directive 67/548/EEC based ona 48 hour EC50 in invertebrates (Daphnia magna) of 45 mg/L (BASF, 1990), a 72 hour LC50 in freshwater fish (Oncorhynchus mykiss) of 976 mg/L (BASF, 1987), a 72 -hrEC50 of >1000 mg/L (algae), a LogKow of 0.4, and a BCF of 3.16 L/kg.