Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
10 000
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:
0.007 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.001 mg/kg soil dw

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]

0,0086

RHOsusp

bulk density of wet suspended matter

[kg.m-3]

1150

Ksusp water

partition coefficient suspended matter water

[m3.m-3]

0,979

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 = 0,979*0,0086*1000/1150 = 0,00732 mg/kg

The value of Ksusp-water of 0,979 is consistent with the calculated value with EUSES 2.1.1. The tool gives 0,979 putting a Koc QSAR for organic acids 3.16 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 = 0,128*0,1 = 0,000732 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]

0,0086

RHOsoil

bulk density of soil

[kg.m-3]

1701

Ksoil water

partition coefficient soil water

[m3.m-3]

0,295

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 = 0,0086/1701*0,295*1000= 0.00149 mg/kg

Conclusion on classification

According to CLP Regulation the criteria for classifying and categorising substances as “hazardous to the aquatic environment” are:

Acute (short-term) aquatic hazard

Category Acute 1:

96 hr LC50 (for fish)                                                  ≤ 1 mg/l and/or

48 hr EC50 (for crustacea)                                          ≤ 1 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquaticplants)        ≤ 1 mg/l.

but for none of the throphic level a LC50< 1 mg/l has been reported, therefore no classification for environmental acute toxicity is warranted

Non rapidly degradable substances for which there are adequate chronic toxicity available

Taking into account the value of IC50 algae 72h = >100 mg/L, and the Log Kow << 4 the substance is not classified for the environment.

Nevertheless the most sensitive specie has been indicated by acute studies to be the daphnia, therefore a long term test is proposed to strengthen the assessment