Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.1 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.31 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
5.21 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:
31 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning method using EUSES 2.1. The following data have been taken into account for calculation: 

 

LC50 (fish)

10.65 mg/L

NOEC (fish)

0.115 mg/L

EC50 (daphnia)

1.55 mg/L

NOEC (daphnia)

0.19 mg/L

NOEC (algae)

31 µg/L

Molecular weight

467 g/mol

Melting point

50.2°C

Vapour pressure

4.12E-6 Pa at 25°C

Water solubility

 1.25 mg/L at 23°C

Log Kow

7.32

Kp (solids-water in soil)

10000 L/kg

Kp (solids-water in sediment)

10000 L/kg

Kp (solids-water in suspended matter)

16800 L/kg

Kp (solids-water in sewage sludge)

300 L/kg

PNEC freshwater

3.1 µg/L

PNEC marine water

0.31 µg/L

Conclusion on classification

The most sensitive species was algae. The NOEC of the target substance Di-C12-18 alkyldimethyl ammonium chloride was 0.031 mg/L. This value is used to derive the PNECs.

 

The substance is not readily biodegradable. The measured BCF for the closely related substance DODMAC is 13 L/kg and therefore the bioconcentration potential is very low. The bioaccumulation criterion (BCF >= 100 L/kg) is not fulfilled.

 

Therefore, based on the results above Di-C12-18 alkyldimethyl ammonium chloride is classified as Aquatic acute category 1 (M-factor 10) and Aquatic chronic category 1 (M-factor 1) in accordance with Regulation EC No 1272/2008.