Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.011 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:
0.006 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The substance 2 -[[(4 -aminophenyl)-(2 -hydroxyethyl)]amino]ethanol sulphate is not readily biodegradable and it is not potentially bioaccumulable taking into account its low log Kow.

Based on the lowest acute EC50 obtained on Daphnia and algae which are between 0.1 and 1 mg/L, the substance is classified for the aquatic environment as acute category 1.

Taking into account the lack of biodegradation and the long-term effects on Daphnia and algae with the NOEC/EC10 between 0.1 and 1 mg/L, the substance is also classified as chronic category 2.

In accordance with the guidance on the application of the CLP criteria (version 5.0 - July 2017) the aquatic hazard classification Acute Cat. 1 and Chronic Cat. 2 with the associated Hazard statement H400 and H411 respectively, will result with the following label : GHS 09, Warning, H410: Very toxic to aquatic life with long lasting effects, P273, P391, P501.