Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.026 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.26 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.062 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:
0.108 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

The environmental classification of the test substance is currently not harmonized according to the CLP Regulation (EC) 1272/2008 and the Dangerous Substance Directive 67/548/EC.

Based on available acute toxicity data, the lowest valid effect concentration for freshwater aquatic organisms is 26 mg/L (EC50 value for daphnia).

The substance is not readily biodegradable; its logKow is < 4. Based on available data the substance should not be classified for acute toxicity. From the acute data, daphnia appear to be the most sensitive species. No chronic daphnia data are available but calculations with ECOSAR v 1.11 following the aliphatic amines class, gives a chronic Daphnia value (ChV) of approx. 7.2 mg/L. As the measured NOEC value for algae is > 1 mg/L (12.5 mg/L for algae, no other measured long-term studies are available), and the predicted chronic value for Daphnia (the most sensitive species) is also above 1 mg/L, the substance should not be classified for chronic toxicity either, following section 4.1.2.6 of the CLP Regulation.