Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.079 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:
0.13 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification based on biodegradation, bioaccumulation and acute aquatic data

Biodegradation:      4% within 28 d (OECD 301F)

LogKow:                  0.59 (OECD 107)

Aquatic acute toxicity

For fish: LC50(96 h) > 100 mg/L, (OECD 203, zebra fish)

For aquatic invertebrates: EC50(48h) = 49.4 mg/L (OECD 202, Daphnia Magna)

For algae: ErC50(72 h) > 100 mg/L, (OECD 201, Desmodesmus subspicatus)

Based on the data above, the substance is considered to be not rapidly degradable and indicates a low potential for bioaccumulation.

Classification and labelling according to Regulation (EC) No.1272/2008 (CLP):

The criteria for classification of a substance in category Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC50); classification is required for values ≤ 1 mg/L. Therefore, the substance does not need to be classified for acute (short-term) aquatic hazard.

No chronic data are available and hence, the result from the short-term tests have to be assessed according to the respective criteria for chronic aquatic hazard in combination with the biodegradation and bioaccumulatoin (log Pow as for this tonnage band BCF is not available) data. In the absence of chronic data the chronic classification for Category 3 is based on acute aquatic toxicity data > 10 to ≤ 100 mg/L for daphnia (49.4 mg/L) and the fact that the substance is not rapidly degradable although the substance indicate a low potential of bioaccumulation.