Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.187 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.019 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.21 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:
0.411 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Short-term toxicity results for fish, Daphnia and algae are available for the substance. The 96h-LC50 for fish was >0.61 mg/L, no effects were observed. The 48h-EC50 for Daphnia magna was 0.21 mg/L. The 72h-ErC50 and 72h-ErC10 for algae are 0.187 mg/L and 0.081 mg/L, respectively. The substance is not readily biodegradable, Log Kow = 5.4.

Short-term (acute) aquatic hazard

According to Table 4.1.0(a) of the CLP regulation, the substance should be classified as Acute Cat. 1, since the EC50 of both algae and Daphnia are <=1 mg/L. The M factor is 1.

Long-term (chronic) aquatic hazard

The only available chronic value is the 72h-ErC10 for algae. The chronic classification has to be determined based on this chronic value according to Table 4.1.0 (b) (i) (as the substance is not readily biodegradable) and based on the available EC50 value for Daphnia and environmental fate data according to Table 4.1.0 (b) (iii). The most stringent outcome is leading:

- As the ErC10 of algae is <= 0.1 mg/L, the substance needs to be classified as Chronic Cat. 1 based on this available chronic value.

- As the EC50 value for Daphnia is <= 1 mg/L, and the substance is not rapidly biodegradable and has a Log Kow > 4, the substance needs to be classified as Chronic Cat. 1 based on this key value also.

It is therefore concluded that the substance needs to be classified as Acute Cat. 1 and Chronic Cat. 1 according to the CLP Regulation. Corresponding M factors are 1 for both acute and chronic toxicity.