Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.13 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
305 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.013 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.176 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:
0.06 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
300 mg/kg food
Assessment factor:
30

Additional information

In absence of data on birds a calculation has been performed

PNECoral= Tox/AF

Tox= NOAELoral* conversion factor

The NOAEL oral is derived from a dietary study with 1% incorporated in food and converted to mg/kg bw. Therefore the original value of 10 g/kg food is taken as the value for Tox. The assessment factor is 30 (based on chronic data in rat, TGD part 2).

Conclusion on classification

All L/EC50's are >1 mg/L (lowest actual value is greater than 30.5 mg/L with algea, Migchielsen, 2010).

The freshwater algal growth inhibition test yields a EC10 (72h) of 6.5 mg/L (Migchielsen, 2010). Furthermore, the substance is readily biodegradable (Birch, 1989) and has a low potential for bioaccumulation.

Classification is not required for acute aquatic hazard if L/EC50's are > 1 mg/L; classification is not required for long-term aquatic hazard if EC10 > 1 mg/L .

Therefore in accordance with Regulation (EC) No. 286/2011 Table 4.1.0 the substance is not classified.

Justification for use of algal EC10: The reported NOEC for this study based upon time weighted average (TWA) concentrations do not accurately represent the intrinsic toxicity of the substance, which due to the issues with the lack of analytical detection of the test substance, the TWA concentrations that must be used resulted in a huge spacing factor between the LOEC and NOEC. EC10 better represent the potential toxicity of the substance as these are conservative estimates that biologically significant adverse effects are being demonstrated in the test.