Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.033 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:
0.015 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-waterp*PNECwater*1000/RHOsus

Where:

PNECwater

Predicted No Effect Concentration in water

[mg.l-1]

0.0773

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]

 0.0658

 

Dry weight: 0.0658 * 4.6 = 0.3027

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

 

Kpsusp= Focsusp*Koc

The value of Ksusp-water of 0.979 is consistent with the calculated value with EUSES 2.1.1.

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 = 0.0658*0.1 = 0.00658 mg/kg.

Dry weight = 0.00658

* 4.6 = 0.06119

PNEC soil using Equilibrium Partitioning Method:

The following formula is applied:

PNECsoil= Ksoil-water*PNECwater*1000/RHOsoil

Where:

ECwater

Predicted No Effect Concentration in water

[mg.l-1]

0.0773

RHOsoil

bulk density of soil

[kg.m-3]

1700

Ksoil water

partition coefficient soil water

[m3.m-3]

0.295

PNECsoil

Predicted No Effect Concentration in soil

[mg.kg-1]

0.0134

  

Dry weight = 0.0134*1.13 = 0.01516

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

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

Kpsoil= Focsoil*Koc

Conclusion on classification

Based on the results of the eco-tox tests, Acid Blue 113 needs to be classified as Aq. Chronic 3, H412 under Regulation 1272/2008 (CLP) since the tested item shows toxicity on fish with a EC50 (96h) = 77.3 mg/l.

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