Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.04 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.74 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:
4.56 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.556 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

Official classification regarding environmental hazards

Aquatic compartment

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is officially classified as "Aquatic Chronic 2".

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is officially classified as "N; R51 -53".

 

Self-classification

Aquatic compartment

Following DSD/DPD, the substance is to be classified as dangerous for the aquatic environment (N, R51/53).

Rationale:

The lowest acute toxicity to aquatic organisms (LC/EC50) is between 1 and10 mg/L and the substance is not readily biodegradable.

 

Following GHS,

Self-classification

Following GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. The substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 3).

Rationale:

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L.

 

Chronic data are available only for Daphnia and algae, therefore classification is based on the available chronic and acute toxicity data:

- Chronic toxicity data: Chronic data are available for Daphnia (NOEC = 4.0 mg/L) and algae (ErC10 = 4.1 mg/L), indicating the substance to be not classified according to the categories outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008).

- Acute toxicity data: Fish is the only trophic level not covered by chronic data. Therefore, classification is based on the acute effect data. The LC50 is between 10 and 100 mg/L.

In conclusion, the substance is to be classified according to the categories outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), based on the 96-h LC50 determined for fish. The substance is non-rapidly degradable; the BCF is < 100. Therefore the substance is to be classified as chronically hazardous (Category Chronic 3).

 

Conclusion: Following GHS, the substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 3).