Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.015 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:
6.73 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.673 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

There is no data in Regulation (EC) 1272/2008 Annex VI Table 3.1 and 3.2 for the substance available yet.

 

Self-classification

Aquatic compartment

Following DSD/DPD, the substance is to be classified as toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment (N, R51/53).

Rationale:

- The acute toxicity to aquatic organisms (LC/EC50) is between 1 and 10 mg/L in freshwater (algae, 72 -h ErC50: 5 mg/L).

- The substance is not readily biodegradable (freshwater) and the measured BCF is < 60 of the substance.

 

Following GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute and chronic data, the substance is to be classified as chronically hazardous to the aquatic environment (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 for algae and invertebrates, therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data:

Chronic data are available for algae (72h ErC10 = 1.55 mg/L) and invertebrates (daphnids, 21 d NOEC: 4.0 mg/L) indicating that the substance does not present a long-term hazard according to the categories outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for non-rapidly degradable substances.

- Acute toxicity data:

Acute toxicity to aquatic organisms (LC/EC50) is between 10 and 100 mg/L in freshwater (96h LC50 fish: 22.4 mg/L).

The substance is not rapidly biodegradable and the BCF is < 500.

In conclusion, the substance is to be classified as chronically hazardous to the aquatic environment (chronic 3).

Atmospheric compartment

The test substance is not listed in Annex I of Regulation (EC) 2037/2000 on substances that deplete the ozone layer.

 

The test substance does not belong to the green house gases listed in P Forster, PV Ramaswamy et al. Changes in Atmospheric Constituents and in Radiative Forcing. In: Climate Change 2007: The Physical Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on climate Change.

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