Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 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:
2.35 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.235 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:
0.468 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33.3 mg/kg food

Additional information

Appropriate long-term studies on the environmental toxicity of the test substance are not available. Following ECHA guidance R.10, the environmental PNECs were derived from the lowest L(E)C50 value observed in the available valid acute toxicity studies conducted with three species from three trophic levels. The study with Daphnia magna resulted in the lowest EC50 value of 1.6 mg/L and this concentration was used as the starting point of PNEC derivation. No studies on the toxicity to sediment-dwelling organisms or soil organisms are available. The PNECs were calculated from the respective PNECs aqua with the equilibrium partitioning method, which is applicable for substances with log Kow values between 3 and 6. As the log Kow of the substance is > 5, an additional assessment factor of 10 will be applied in the risk assessment.

Conclusion on classification

All acute toxicity tests resulted in L(E)C50 values > 1 mg/L. The substance therefore does not need to be classified for acute aquatic hazard in accordance with Regulation (EU) No 286/2011 amending for the second time CLP Regulation (EC) No 1272/2008. No long-term studies are available that may be used for classification of potential long-term hazards. As the L(E)C50 values observed in the acute toxicity tests conducted with fish and daphnids were in the range from 1 to 10 mg/L and the substance is not rapidly biodegradable, the substance is to be classified for long-term hazard (Category Chronic 2, H411) in accordance with Regulation (EU) No 286/2011 amending for the second time CLP Regulation (EC) No 1272/2008 (Table 4.1.0 giving classification categories for hazardous to the aquatic environment).