Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.011 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.011 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.01 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:
0.014 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral

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 not to be classified as dangerous for the environment.

Rationale:

- The acute toxicity to aquatic organisms (LC/EC50) is greater than 1 mg/L in freshwater (lowest value: algae 1.08 mg/L; there is no real EC50 value available. Therefore the calculated EC0 out of four read-across substances was used as worst case scenario).

- The substance is readily biodegradable (freshwater) and the log Pow is <3.

 

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 not to be classified as chronically hazardous to the aquatic environment.

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 only for algae (calculated 72h ErC0 = 1.08 mg/L; read-across approach with calculated EC0 as worst case scenario) and invertebrates (7d NOEC = 1.5 mg/L; read-across from Ceriodaphnia dubia with butylamine) indicating that the substance does not present a long-term hazard according to the categories outlined in Table 4.1.0(b) (ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for rapidly degradable substances.

- Acute toxicity data:

Acute toxicity to aquatic organisms (LC/EC50) is >100 mg/L in freshwater (48h EC50 Daphnia: > 100 mg/L, 96h LC50 fish: > 500 mg/L).

The substance is rapidly biodegradable (freshwater) and the log Kow is <4.