Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.004 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:
0.232 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.023 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:
0.021 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 0.043 mg/l has been derived from 43 mg/l (EC50 value-72 h) for effects on alga growth inhibition test (the lowest short-term E/LC50 from each of 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 (EC50 = 43 mg/l), applying an assessment factor of 10000 to give PNECseawater = 0.0043 mg/l.

The intermittent releases PNEC is derived from lowest value obtained for freshwater species (EC50 = 43 mg/l), applying an assessment factor of 100 to give PNECwater,intermittent = 0.43 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) = 0.2322 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) = 0.02322 mg/kg will be used for risk characterisation.

No soil 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 =0.0205 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

0.043 mg/l

STP micro-organisms

100 mg/l

Seawater

0.0043 mg/l (extrapolation from freshwater)

intermittent release

0.43 mg/l (extrapolation from freshwater)

PNECsediment (freshwater)

0.2322 mg/kg dw

PNECsediment (marine water)

0.02322 mg/kg dw

PNECsoil

0.0205 mg/kg dw

Conclusion on classification

Based on acute aquatic toxicity data available, negative log POW and good water solubility the substance does not fulfill the criteria for classification for acute aquatic toxicity. However, given the lack of biodegradability, the substance shall be classified for chronic aquatic toxicity, category 3 in combination with the EC50 (algae, growth rate) according to CLP (Regulation EC No 1272/2008) and consequently as R52/53 according to DSD (Directive 67/548/EEC).