Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Additional information

Hydrolysis studies show that isobutyric anhydride added to water rapidly converts to isobutyric acid. Thererfore, isobutyric acid data is being used by read across for most environmental fate and ecotox endpoints.

Conclusion on classification

Following DSD/DPD, the substance is not to be classified as dangerous for the environment since the acute toxicity is >10 to <=100 mg/L, the substance is readily biodegradable and does not bioaccumulate significantly (experimentally determined log Kow < 3).

Following CLP, the substance is not to be classified as hazardous to the aquatic environment since the acute toxicity is >10 to <=100 mg/L, the substance is readily biodegradable and does not bioaccumulate significantly (experimentally determined log Kow <= 4). The only long-term data point for algae (72 hour EC10 = 29.4 mg/L) is > 1.0 mg/L and thererfore does not affect the chronic hazard classification.