Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.006 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.016 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC sediment using Equilibrium Partitioning Method:

The following formula is applied:

PNECsed= Ksusp-water/RHOsusp*PNECwater*1000

Where:

PNECwater

Predicted No Effect Concentration in water

[mg.l-1]

0.07

RHOsusp

bulk density of wet suspended matter

[kg.m-3]

1150

Ksusp water

partition coefficient suspended matter water

[m3.m-3]

0,9474

PNECsed

Predicted No Effect Concentration in sediment

[mg.kg-1of wet sediment]

 

 

 

Ksusp water= Fwatersusp+ Fsolidsusp*Kpsusp/1000*RHOsolid

Fwatercomp

fraction water in compartmentcomp

[m3.m-3]

0,9

Fsolidcomp

fraction solids in compartmentcomp

[m3.m-3]

0,1

RHOsolid

density of the solid phase

[kg.m-3]

2500

Kpcomp

solids-water part. coeff. in compartmentcomp

[l.kg-1]

0,1896

 

Kpsusp= Focsusp*Koc

Koc

partition coefficient organic carbon-water

[l.kg-1]

1,896 calculated with EPIWIN 4.00

Foccomp

weight fraction of organic carbon in compartmentcomp

[kg.kg-1]

0,1

Kpsusp

partition coefficient solid-water in suspended matter

[l.kg-1]

 

 

Therefore PNEC sediments = 0,9474*0,07*1000/1150 = 0.0577 mg/kg

The value of Ksusp-water of 0,9474 is consistent with the calculated value with EUSES 2.1.1. The tool gives 0,913 putting a Koc QSAR for organic acids and 0,979 for non hydrophobic substances

 

PNEC marine sediment using Equilibrium Partitioning Method:

Being marine PNEC usually derived by freshwater PNEC with an adding assessment factor of 10, consequently the marine sediment PNEC can be directly derived from PNEC sediment with an assessment factor of 10.

Therefore PNEC marine sediments = 0.0577*0.1 = 0.00577 mg/kg

 

PNEC soil using Equilibrium Partitioning Method:

Results with EUSES 2.1.1 for Ksoil-water: 0.228 – 0.307

 

The following formula is applied:

PNECsoil= Ksoil-water/RHOsoil*PNECwater*1000

Where:

PNECwater

Predicted No Effect Concentration in water

[mg.l-1]

0.07

RHOsoil

bulk density of wet suspended matter

[kg.m-3]

1150

Ksoil water

partition coefficient soil water

[m3.m-3]

0,269

PNECsoil

Predicted No Effect Concentration in soil

[mg.kg-1]

 

 

 

Ksoil water= Fairsoil*Kair-waterl+Fwatersoil+ Fsolidsoil*Kpsoil/1000*RHOsolid

Fwatersoil

fraction water in compartmentsoil

[m3.m-3]

0.2

Fsolidsoil

fraction solids in compartmentsoil

[m3.m-3]

0.6

Fairsoil

fraction air in compartment comp (only relevant for soil)

[m3.m-3]

0.2

RHOsolid

density of the solid phase

[kg.m-3]

2,500

Kpsoil

solids-water part. coeff. in compartmentsoil

[l.kg-1]

0,038

Kair-water

air-water partitioning coefficient

[-]

0,0629

 

Kpsoil= Focsoil*Koc

Koc

partition coefficient organic carbon-water

[l.kg-1]

1,896 calculated with EPIWIN 4.00

Focsoil

weight fraction of organic carbon in compartmentsoil

[kg.kg-1]

0,02

Kpsoil

partition coefficient solid-water

[l.kg-1]

0.038

 

Kair-water= 149(Henry constant at environmental temperature)/285(T°K)/8.314(R, gas constant) =0,0629

Therefore PNEC soil = 0,269/1150*0,07= 0,016 mg/kg

 

Conclusion on classification

None of the studies shows a value leading to classification for the environement both according to 67/548 and to CLP regulation.