Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.054 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:
0.049 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Study reports have been available for consideration in respect of acute tests with fish, invertebrates, algae and micro-organism.

A PNECaquatic of 0.1 mg/l has been derived from 100 mg/l (the L/EC50 for the three trophic levels (fish, Daphnia and algae)) by an assessment factor of 1000.

No measured data are currently available for marine organisms therefore the marine PNEC is derived from data obtained for freshwater species (L/EC50=100 mg/l), applying an assessment factor of 10000 to give PNECseawater = 0.01 mg/l.

The intermittent releases PNEC is derived from lowest value obtained for freshwater species (L/EC50 = 100 mg/l), applying an assessment factor of 100 to give PNECwater,intermittent = 1 mg/l.

The PNEC for waste-water treatment is 100 mg/l based on the NOEC of 1000 mg/l and an assessment factor of 10.

No toxicity data are currently available for sediment-dwelling organisms, therefore it is not possible to determine a PNECsed based on measured data. According to the Technical Guidance Document, PNECsed can be calculated by the equilibrium partitioning method. Hence, PNECsed (freshwater) = 0.54 mg/kg will be used for risk characterisation.

No toxicity data are currently available for marine sediment-dwelling organisms, therefore it is not possible to determine a PNEC sediment (marine water) based on measured data. According to the Technical Guidance Document, PNEC sediment (marine water) can be calculated by the equilibrium partitioning method. Hence, PNEC sediment (marine water) =0.054 mg/kg will be used for risk characterisation.

No toxicity data are currently available, therefore it is not possible to determine a PNECsoil based on measured data. According to the Technical Guidance Document, PNECsoil can be calculated by the equilibrium partitioning method. Hence, PNECsoil =0.0492 mg/kg will be used for risk characterisation.

Below table is the summary of the value of PNEC in each compartment.

Compartment

Value of PNEC

Freshwater

0.1 mg/l

STP micro-organisms

100 mg/l

Seawater

0.01 mg/l (extrapolation from freshwater)

intermittent release

1 mg/l (extrapolation from freshwater)

PNECsediment (freshwater)

0.54 mg/kg

PNECsediment (marine water)

0.054 mg/kg

PNECsoil

0.0492 mg/kg

Conclusion on classification

From the available information, the lowest short-term EC/L50 from each of three trophic levels (fish, Daphnia and algae) was above 100 mg/l. Therefore, it is not classified as per EU CLP (Regulation (EC) No 1272/2008) regulation or DSD (Directive 67/548/EEC).