Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.022 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:
0.011 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

1) PNEC sediment using Equilibrium Partitioning Method:
The following formula is applied:

PNECsed= Ksusp-water/RHOsusp*PNECwater*1000

Where:

PNECsed = Predicted No Effect Concentration in sediment [mg. kg-1of wet sediment]

Ksusp water = partition coefficient suspended matter water [m3. m-3]

RHOsusp = bulk density of wet suspended matter [kg. m-3]

PNECwater = Predicted No Effect Concentration in water [mg. l-1]

 

For Acid Orange 7 the formula with the values is:

 

PNEC sediments = (0,984/1150) * 0,056 * 1000 = 0,0479 mg/kg wet weight

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

PNEC sediments dry weigth = 0,0479 * 4.6 = 0,22 mg/kg dry weight

The value of Ksusp -water of 0,984 is consistent with the calculated value with EUSES 2.1.1.

2) 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.

PNEC marine sediments = 0,0479 * 0,1 = 0,00479

PNEC marine sediments dry weigth = 0,00479 * 4.6 = 0,022 mg/kg dry weigth

3)PNEC soil using Equilibrium Partitioning Method:

The following formula is applied:

PNECsoil= Ksoil-water/RHOsoil*PNECwater*1000

Where:
PNECsoil = Predicted No Effect Concentration in soil [mg. kg-1]
Ksoil water = partition coefficient soil water [m3. m-3]
RHOsoil =bulk density of wet suspended matter [kg. m-3]
PNECwater = Predicted No Effect Concentration in water [mg. l-1]

PNEC soil = (0.301/1700) * 0.056 * 1000 = 0,0099 mg/kg wet weight

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

PNEC soil dry weight = 0.0099*1.13 = 0.0112 mg/kg dry weight

Conclusion on classification

No classification is warranted under the CLP Regulation (EC n. 1272/2008).