Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 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:
0.003 mg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

Aquatic toxicity

To assess the short-term toxicity of the registered substance to aquatic organisms, QSAR predictions of reliability 1 (Klimisch rating), were performed for the three aquatic trophic levels (algae, aquatic invertebrate and fish), and a reliability-3 study on Zebra fish was performed.

Among all acute data available, the reliability-3 study gave the lowest fish 96h-LC50 (30.5 mg/L) but the procedural average recovery was 46.9%. Multipling this value by two gives a closer 96h-LC50 value (60.8 mg/L)

to the valid QSAR value of 71 mg/L.

For the aquatic invertebrate Daphnia magna the predicted 48h-EC50 was 175 mg/L and for the algal growth inhibition test, the predicted 72h-ErC50 was 367 mg/L.

Environmental fate and pathways

The registered substance is readily biodegradable but does not fulfill de 10-day window criteria. With a log Kow of 1.3, it suggests that the registered substance does not have a potentiel for bioaccumulation, having low affinity for lipids present in organisms.

Conclusion on classification

QSAR predictions allowed to obtain short-term E(L)C50 values for the three trophic levels (fish, aquatic invertebrate and algae) of respectively 71 mg/L, 175 mg/L and 367 mg/L.

The substance has a log Kow of 1,3 and is readily biodegradable but does not fulfill the 10-day window criteria.

These data are consistent with the following classification under Regulation (EC) No1272/2008 (as amended) (CLP):

Acute toxicity : not classified

Chronic toxicity : Category 3

- Lowest LC50 : between 10 and 100 mg/L for fish; for other organisms toxicity was >100 mg/L

- Log Kow = 1.3

- Readily biodegradable but not fulfilling the 10-day window criteria.

Classification according to the Annex I of the Regulation (EC) No1272/2008 (CLP): The registered substance is classified as Aquatic Chronic Category 3 for the environment.