Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.024 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:
4.21 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
24.3 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:
48.6 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Acute freshwater data was available for three trophic levels, fish, Daphnia and algae. Aquatic PNECs were calculated from the lowest L(E)C50 of 2.43 mg/L. The PNECs were as follows:

PNECfreshwater = 0.00243 mg/L

PNECmarine water = 0.000243 mg/L

PNECintermittent = 0.0243 mg/L

The PNEC for the STP was calculated from a respiration inhibition test EC50 of 421 mg/L.

PNECstp = 4.21 mg/L

For soil and sediment PNECs the equilibrium partitioning method is used. EPM PNECs were calculated in EUSES with the following key inputs:

KOC: 1,000,000 (EUSES maximum)

Molecular weight: 823 g/mol

Vapour pressure: 0 pa (vapour pressure is extremely low so is set to 0 for practical purposes)

Water solubility: 0.0000013 (worst case value for equilibrium partitioning).

The PNECs were as follows:

PNEC sediment = 243 mg/kg dw

PNECmarine sediment = 24.3 mg/kg dw

PNECsoil = 48.6 mg/kg/dw

Conclusion on classification

The lowest acute EC50/LC50 derived was 2.43 mg/L. As the test substance is not considered readily biodegradable this leads to a classification of toxic to aquatic organisms - chronic category 2.

H411 - toxic to aquatic organisms with long lasting effects.