Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.005 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.237 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:
5.32 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Some of tests used to define the environmental hasard categories are based on alkylamines read-across performed with natural river water. Due to their intrinsic properties (cationic, surfactants), river water ecotoxicity test deliver reproducible results with limited uncertainty.

 

As river water has a mitigating effect on ecotoxicity due to sorption of the primary alkylamines to the suspended matter, a factor of 10 should be applied to the data obtained to correct for the lower ecotoxicity observed.

Conclusion on classification

The environmental fate and ecotoxicological properties of the registered salt are equivalent to the properties of Amines, C16-18-alkyl (CAS 90640-32-7). As the effect endpoints were related to only one of the ions, therefore the classification of the salt use the effect concentration multiplied by the molecular weight ratio of the substance (according REACH guidance document R7b v4, June 2017 p 81).

The classification of the registered substance according to CLP regulation 1272/2008 EC is defined by :

Aquatic acute category

 

96h-LC50 fish was 2.9 mg/L (corrected by a factor 10 due to river water testing, that yields 0.29 mg/L)

 

48h-EC50 invertebrates was 1,1 mg/L (corrected by a factor 10 due to river water testing, that yields 0.11 mg/L)

 

72h-ErC50 algae was 0.55 mg/L (corrected by a factor 10 due to river water testing, that yields 0.055 mg/L)

 

The registered substance is therefore considered Aquatic Acute Category I, H400 M=10.

 

Aquatic chronic category

 

Long-term test result for fish is not available.

 

21d-NOEC for daphnia was 0,034 mg/L (corrected by a factor 10 due to river water testing, that yields 0,0034 mg/L)

 

72h-EC10 for algae was 0,2 mg/L (corrected by a factor 10 due to river water testing, that yields 0,02 mg/L)

It has to be noted that the registered substance is not biodegradable. Therefore, it is classified Aquatic Chronic Category I, H410 M=10