Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.13 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.013 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.837 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:
5 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

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]

0,13

RHOsusp

bulk density of wet suspended matter

[kg.m-3]

1150

Ksusp water

partition coefficient suspended matter water

[m3.m-3]

251

PNECsed

Predicted No Effect Concentration in sediment

[mg.kg-1of wet sediment]

 

 

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

 

Kpsusp= Focsusp*Koc

Therefore PNEC sediments = 251*0,13*1000/1150 = 28,37 mg/kg

The value of Ksusp-water of 251 is based on the conservative Log Koc = 4 used for the category

 

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 = 28,37*0,1 = 2,837 mg/kg

 

PNEC soil using Equilibrium Partitioning Method:

Results for Ksoil-water: 300

The following formula is applied:

PNECsoil= Ksoil-water/RHOsoil*PNECwater*1000

Where:

PNECwater

Predicted No Effect Concentration in water

[mg.l-1]

0,13

RHOsoil

bulk density of soil

[kg.m-3]

1701

Ksoil water

partition coefficient soil water

[m3.m-3]

300

PNECsoil

Predicted No Effect Concentration in soil

[mg.kg-1]

 

  

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

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

Kpsoil= Focsoil*Koc

Therefore PNEC soil = 0,13/1701*300*1000= 22.93mg/kg

The most conservative PNEC soil value of 5 based on acute experimental tests has been selected for Risk Assessment

Conclusion on classification

Biodegradation in water: not rapidly biodegradable

LogKow: < 0 (non bioaccumulative)

 

Acute toxicity:

- to Fish: LC50 (96h) (Danio rerio) > 100mg/L

 - to Algae ErC50 (72h) (Desmodesmus subspicatus) >100 mg/L

 - to Crustacea EC50 (48h) (Daphnia magna) > 100 mg/L

 

Chronic toxicity:

- to Crustacea NOEC (21d) = 6.59 mg/l

 

Classification justification according to CLP:

Based on the data above, CAS 68971-49-3 is determined to be not rapidly degradable. No acute aquatic toxicity was observed. Valid chronic toxicity data are available for Daphnia – NOEC (21 d) > 1 mg/L. Therefore CAS 68971-49-3 is not classified for the environment according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).