Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.125 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:
0.018 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Reliable short-term data is available for the three trophic levels for both the freshwater and the marine water compartment.

The most sensitive compartment is the freshwater compartment, with the lowest 72-h ErC50 value (for algae) being 15 mg/L. For daphnia and fish acute EC/LC50 values of 80 mg/L and > 15 mg/L respectively were obtained. The substance is not readily biodegradable; its logKow is < 4. Based on the available data, the substance should not be classified for acute toxicity.

The ErC10 value for algae was greater than 1 mg/L. No chronic daphnia or fish data are available but calculations with ECOSAR v 1.11 following the aliphatic amines class, give a chronic Daphnia and fish value (ChV) of approx. 1.85 and 16.21 mg/L respectively. As the chronic toxicity values are higher than 1 mg/L, the substance should not be classified for chronic toxicity following Annex I, table 4.1.0 b (i) of the CLP Regulation.

However following a conservative approach (not taking the QSAR data into account), and considering that the substance is not rapidly degradable and shows acute toxicity values > 10 to ≤ 100 mg/L, it should be classified as:

Chronic Category 3, H412, according to CLP (EC Regulation 1272/2008)

R52/53, according to DSD (EC Directive 67/548)

No labelling is required