Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.694 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:
11.3 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

Acute effect levels for the freshwater species tested are >100 mg/L (LC50 fish), 88 mg/L (48h-EC50 invertebrates) and >100 mg/L (algae; 72h-EC50 growth rate).

Long-term effect levels for the freshwater species tested are >110 mg/L (28d-NOEC fish), 7.95 mg/L (21d-NOEC invertebrates) and 4.6 mg/L (72h-NOErC algae).

Conclusion on classification

DSD: following the lowest acute effect level being in the range of 10 - 100 mg/L (88 mg/L, EC50 for daphnia), and the substance being not readily biodegradable, the substancewould be considered to be harmful to aquatic organisms and may cause long-term adverse effects in the aquatic compartment (R52/53). However, additional scientific evidence is available on the lack of long-term toxicity in the three trophic levels (fish, daphnids, algae) at a concentration of 1 mg/L. Therefore classification with R52/53 is not warranted. The substance is thus not classified for the environment according to the classification rules in DSD.

CLP: although the lowest acute effect level is in the range of 10 - 100 mg/L (88 mg/L, EC50 for invertebrates) and the substance is not readily biodegradable, no long term adverse effects are anticipated as the chronic toxicity NOEC's for fish, invertebrates and algae are > 1 mg/L; therefore, no classification for the environment is assigned according to the classification rules in CLP (taking into account the 2nd ATP).