Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.37 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
3.7 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.037 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.37 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.45 µg/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:
0.688 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Acute aquatic toxicity test results are used in the risk assessment since chronic data were not available. Aquatic toxicity against aquatic invertebrates, fish and algae is addressed by experimental results. The lowest short-term toxicity value is the ErC50 in Pseudokircheneriella subcapitata of 0.37 mg/L. In an activated sludge nitrification inhibition study an EC50 of 636 mg/L was determined. Therefore, the substance is considered to elicit adverse effects against aquatic/STP organisms that would identify a relevant hazard and justifies PNEC derivation for regulatory purposes.

Conclusion on classification

In acute aquatic toxicity tests, the test item revealed LC50/EC50 values below 1 mg/L, and thus needs to be classified as hazardous to the aquatic environment in accordance with Section 4.1.2.6., Annex I of Regulation 1272/2008/EC. As the test item is not considered readily biodegradable, the relevant classification is Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410).