Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.005 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:
17 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
5.6 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
2 mg/kg food
Assessment factor:
30

Additional information

Conclusion on classification

Classification as "R50 /53 Dangerous for the environment; Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment" was formerly agreed upon at the EU level under the Dangerous Substances Directive. Classification as R50 is based on ecotoxicologal data from daphnia (EC50=0.5 mg/L). However, classification of R53 does not apply according to current status of evaluation. In fact, the substance is not biodegradable, however it does not fulfill the second criterion logPow>3. The measured logPow is 1.16.

The experimental values for aquatic toxicity along with the applied assessment factors ensure that the PNECs are very conservative and protective of organisms in the environment. Using the acute toxicity value of 0.5 mg/L for Daphnia (BayerAG, 1993) and the chronic toxicity estimate for algae, the test substance meets the criteria for Acute Category 1 and Chronic Category 1 hazardous to the aquatic environment. See: Regulation (EC) No 1272/2008; See Official Journal of the European Union, (2008) Vol. L353, pp. 1-1355, at p. 131. However, classification as chronic cat. 1 should not apply according to existing data. The substance is, in fact, not readily biodegradable, but it does not fulfill the second criterion logPow>4 (measured: logPow=1.16).