Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.32 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Formula for the calculation of PNECsed using the equilibrium partitioning approach for sediment and a Koc prediction based on alcohols:

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 [0.997 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 [0.433 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 very low toxicity of 2 -(2 -butoxyethoxy)ethanol to aquatic species coupled with its ready biodegradability mean that it does not meet the criteria for classification under either directive 67/548 or regulation 1272/2008.