Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 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:
0.242 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

The results from the aquatic toxicity studies are as follows:

LC50 (96 h) fish = 11.3 mg/l (nominal concentration) with 95% confidence limits of 8 -16 mg/l.

EC50 (48 h) Daphnia = 21.1 mg/l (nominal concentration) with 95% confidence limits of 18.4 – 24.3 mg/l.

ErC50 (72 h) algae = 80.6 mg/l (nominal concentration) with 95% confidence limits 78.9-82.3 mg/l.

EC50 microorganisms was determined to be greater than 1000 mg/l.

Based on the results from the aquatic toxicity (values in the range 10 -100 mg/l) and since the substance is not readily biodegradable and has a log Pow of 4, the substance is classified as follows:

- according to Directive 67/548/EEC the substance is classified as R52/53.

- according to the CLP Regulation 1272/2008 the substance is classified as Chronic Category 3.