Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
55 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
7.3 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

A European Risk Assessment Report has been issued in 2002 by German Authorities. Some of the previously defined PNECs have been revisited according to this core document but all the PNECs remain very similar to those presented in the EU RAR.

Conclusion on classification

Quaternary ammonium compounds, di-C16 -C18 (even numbered) - alkyldimethyl, chlorides is considered as very toxic for the aquatic compartment based on the generated aquatic toxicity package with an EC50 -72h for freshwater algae of 0.48 mg/L and for marine algae of 0.24 mg/L. The lowest NOEC value was obtained for algae and was 0.062 mg/L.

Quaternary ammonium compounds, di-C16 -C18 (even numbered) - alkyldimethyl, chlorides is

also considered as persistent in the environment since it is not readily biodegradable.

The measured BCF for DODMAC is 13 L/kg and therefore the bioconcentration potential is very low. The bioaccumulation criteria (BCF >= 100 L/kg) is not fulfilled under DSD 67/548/EEC. Based on these facts and the criteria for classification given in the DSD a R53 has to be assigned. The bioaccumulation criteria (BCF >= 500 L/kg) is not fulfilled under CLP2008/1272/EEC but as the substance is not readily biodegradable a chronic class has to be assigned.

Therefore based on the above mentioned results Quaternary ammonium compounds, di-C16 -18 (even numbered) - alkyldimethyl, chlorides is classified as follows:

Dangerous substance directive:

N-R50/53

Classification Labeling & Packaging:

Aquatic chronic category 1 – H410: very toxic to aquatic life with long lasting effects.

The lowest L(E)C50 value obtained in the frame of the ecotoxicity tests being 0.24 mg/L (marine algae), the M factor is:

Acute M-factor = 1

Chronic M-factor = 1