Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.37 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:
9.25 µg/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: not readily biodegradable; no net degradation of the test item was measured (O2 consumption, OECD 301F, GLP)

LogKow:  1.85 (EpiSuite estimation)

 

Aquatic acute toxicity

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

For aquatic invertebrates: EC50(48h) = 5.95 mg/L (OECD 202, Daphnia Magna)

For algae: ErC50(72 h) > 160 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 bioaccumulation (log Pow as for this tonnage band BCF is not available) data. In the absence of chronic data the chronic classification for Category 2 is based on acute aquatic toxicity data > 1 to ≤ 10 mg/L for daphnia (5.95 mg/L) and the fact that the substance is not rapidly degradable although the substance indicates a low potential of bioaccumulation.