Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.19 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1.9 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.684 µg/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:
0.253 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECsediment-freshwater was estimated using equilibrium partitioning theory as described in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.10

A summary of the calculations are provided:

PNECsediment-freshwater = (Ksusp-water/RHOsusp) x PNECwater x 1000 x CONVsed (Equation 1)

= (0.900/1150) x 0.0019 x 1000 x 4.6

= 0.00684 mg/kg dwt

where:

PNECwater= 0.0019 mg/L

RHOsusp= 1150 kg/m-3

Ksusp-water= 0.900 m3/m-3 (See Equation 2)

CONVsed = 4.6 kg/kg

Intermediate Values:

Ksusp-water= Kair-water+ Fwatersusp+ Fsolidsusp x (Kpsusp/1000) x RHOsolid (Equation 2)

where:

Kair-water = 5.30 x 10-5 (See Equation 3)

Fwatersusp = 0.9 m3/m-3

Fsolidsusp = 0.1 m3/m-3

Kpsusp = 0.001 L/kg (See Equation 4)

RHOsolid = 2,500

Kair-water= Henry / (R x Temp) (Equation 3)

where:

Henry = 0.13 Pa/m3/mol

R = 8.314

Temp: 285K

Kpsusp = Focsusp x Koc (Equation 4)

where:

Focsusp = 0.1 L/kg

Koc = 0.01 L/kg

PNECsediment-marinewas estimated using equilibrium partitioning theory as described in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.10

A summary of the calculations are provided:

PNECsediment-marine = (Ksusp-water/RHOsusp) x PNECmarine x 1000 x CONVsed (Equation 5)

= (0.900/1150) x 0.00019 x 1000 x 4.6

= 0.000684 mg/kg dwt

where:

PNECmarine= 0.00019 mg/L

RHOsusp= 1150 kg/m-3

Ksusp-water= 0.900 m3/m-3 (See Equation 6)

CONVsed = 4.6 kg/kg

Intermediate Values:

Ksusp-water=Kair-water+ Fwatersusp+ Fsolidsuspx (Kpsusp/1000) x RHOsolid (Equation 6)

where:

Kair-water= 5.30 x 10 -5 (See Equation 7)

Fwatersusp= 0.9 m3/m-3

Fsolidsusp= 0.1 m3/m-3

Kpsusp= 0.900 L/kg (See Equation 8)

RHOsolid= 2,500

Kair-water= Henry / (R x Temp) (Equation 3)

where:

Henry = 82,680 Pa/m3/mol

R = 8.314

Temp: 285K

Kpsusp= Focsuspx Koc (Equation 4)

where:

Focsusp= 0.1 L/kg

Koc = 0.01 L/kg


PNECsoil was estimated using equilibrium partitioning theory as described in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.10

A summary of the calculations are provided:

PNECsoil =(Ksoil-water/RHOsoil) x PNECwater x 1000 x CONVsoil (Equation 7)

= (0.200/1700) x 0.0019 x 1000 x 1.13

= 0.000253 mg/kg dwt

where:

PNECwater = 0.0019 mg/L

RHOsoil = 1700 kg/m-3

Ksoil-water= 0.200 m3/m-3(See Equation 8)

CONVsoil = 1.13 kg/kg

Intermediate Values:

Ksoil-water= Fairsoil x Kair-water+ Fwatersoil+ Fsolidsoil x (Kpsoil/1000) x RHOsolid (Equation 8)

where:

Fairsoil = 0.2 m3/m-3

Kair-water= 5.30 x 10-5(See Equation 9)

Fwatersoil = 0.2 m3/m-3

Fsolidsoil = 0.6 m3/m-3

Kpsoil = 0.0001 L/kg (See Equation 10)

RHOsolid= 2,500

Kair-water= Henry / (R x Temp) (Equation 9)

where:

Henry = 82,680 Pa/m3/mol

R = 8.314

Temp: 285K

Kpsoil= Focsoilx Koc (Equation 10)

where:

Focsoil = 0.02 L/kg

Koc = 0.01 L/kg


Conclusion on classification

In accordance with the criteria laid down in Regulation (EC) No 1272/2008, the substance meets the criteria for classification as Aquatic Chronic 3, H412: Harmful to aquatic life with long lasting effects.