Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.062 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.27 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:
5 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

The following data are available for the evaluation of the aquatic toxicity

Short-term toxicity

Fish: LC50 (96 h) > 100 mg/l

Aquatic invertebrates:EC50 (48h) > 100 mg/l

Algae: ErC50 (72h) > 123 mg/l (nominal); NOEC (72h, growth rate) = 30.8 mg/l (nominal)

Long-term toxicity

Fish: NOEC (fry length) < 0.625 mg/l (nominal)

Aquatc invertebrates: NOEC (21d, overall threshold effects and reproduction) = 3.22 mg/l (twa)

The substance is determined to be not rapidly degradable and not bioaccumulative considering its LogPow. No acute aquatic toxicity was observed. Valid chronic toxicity data are available for Daphnia and fish.

The effect level determined for aquatic invertebrates does not permit the classification for the aquatic chronic toxicity.

However, the substance caused significant effects on Zebrafish in an early life stage test, 30 days post hatch. For the parameter hatch, the NOEC was 10.0 mg/l. For the parameters post hatch survival and overall survival, the NOECs were 1.25 and 2.50 mg/l, respectively. For the parameter fry growth (expressed as length and fresh weight) the NOECs were < 0.625 mg/l (length) and 0.625 mg/l (weight). The effect level(NOEC)determined during the long-term toxicity to fish is < 1 mg/l.

Further points are yet to be addressed in the long-term toxicity used for the classification of the aquatic toxicity. For this reason, the classification is given as INCONCLUSIVE until further investigations will be concluded.