Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
10 000
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:
2.6 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.3 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:
1.4 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Due to very poor water solubility the EC50 is based on the limit of solubility where the EC50 is reported as greater than the maximum solubility (> 10 mg/L) and the NOEC for the algal study was reported as equal to the maximum solubility under test conditions.(NOEC > 10 mg/L). Therefore the value of 10 ppm was used as the POD instead of 0.28 ppm which is the lowest NOEC but is overly conservative and is reported as the highest test concentration in the 48 hr daphnia study. Results show the substance is non-toxic at maximum solubility of 10 ppm (nominal)(10 mg/L).

Conclusion on classification

The substance satisfies the criteria for aquatic chronic 4.

Based on the substance's poor water solubility, lack of biodegradable, log Kow of 4.9 and the fact that all of the ecotoxicity test results are greater than the limit of solubility (0.1 mg/L).