Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.108 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.6 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.011 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.08 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:
0.29 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
70 mg/kg food
Assessment factor:
90

Additional information

Formula for the calculation of PNECsed using the equilibrium partitioning approach for sediment:

PNEC(sed) = (Ksed-water x PNEC(aqua) / RHOsed) * 1000

PNEC(sed) Predicted No Effect Concentration in sediment [mg/kg, wet weight]

Ksusp-water partition coefficient sediment / water [1.85 m3/m3]

RHOsed bulk density of sediment matter [1150 kg/m3]

PNECaqua Predicted No Effect Concentration in water [as above]

Formula for the calculation of PNECsed using the equilibrium partitioning approach for soil:

PNEC(soil) = (Ksoil-water x PNEC(aqua) / RHOsoil) * 1000

PNEC(soil) Predicted No Effect Concentration in sediment [mg/kg, wet weight]

Ksoil-water partition coefficient sediment / water [4.10 m3/m3]

RHOsoil bulk density of soil matter [1700 kg/m3]

PNECaqua Predicted No Effect Concentration in water [as above]

The PNEC oral is derived using the critical oral mammalian NOAEL (in mg/kg bw ) as a starting point. This is then converted to a NOEC (in mg/kg food) using the conversion factors in table R10-12 of the guidance from which the PNEC is derived by using the appropriate assessment factor in table R10 -13.

Conclusion on classification

The toxicity of 2 -(2-butoxyethoxy)ethyl acetate falls within the range for potential classification as harmful to aquatic species (based on data for fish). However, the fact that it is readily biodegradable means that it does not meet the criteria for classification.