Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
7.1 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

PNECs for Benzyl were based on (i) new generated data and (ii) existing data for analogous substance. Read-across from N-C16-C18(even numbered)-alkyl-N,N-dimethyl-C16-C18(even numbered)-alkyl-1-aminium chloride (DODMAC/DHTDMAC) is proposed for covering missing endpoints. This read-across is supported by the similarity between the structures (with the benzyl ring exception) and the comparison of the expected sensitive endpoints (acute ecotox data) demonstrating the similarity of the ecotoxicological profiles. The IUCLID includes the assumptions made and for the read-across, existing European Risk Assessment was used as core-document

Conclusion on classification

Dangerous substance directive:

N-benzyl-N-C16-18 (even numbered) -alkyl-N-methyl-C16-18 (even numbered) -alkyl-1-aminium chloride is considered as very toxic for the aquatic compartment based on the generated aquatic toxicity package with an EC50-48h for invertebrates of 0.66 mg/L. The lowest NOEC was obtainded for fish and was 0.23 mg/L (based on a read-across with Quaternary ammonium compounds, di-C16 -18 (even numbered) - alkyldimethyl, chlorides).

N-benzyl-N-C16-18 (even numbered) -alkyl-N-methyl-C16-18 (even numbered) -alkyl-1-aminium chloride is considered to be non bioaccumulative but as the substance is considered not to be readily biodegradable, a chronic class has to be assigned.

Therefore based on the a.m results N-benzyl-N-C16-18 (even numbered) -alkyl-N-methyl-C16-18 (even numbered) -alkyl-1-aminium chloride is classified as follows:

N-R50/53

Classification Labeling & Packaging:

N-benzyl-N-C16-18 (even numbered) -alkyl-N-methyl-C16-18 (even numbered) -alkyl-1-aminium chloride is considered as very toxic for the aquatic compartment based on the generated aquatic toxicity package with an EC50-48h for invertebrates of 0.66 mg/L.

N-benzyl-N-C16-18 (even numbered) -alkyl-N-methyl-C16-18 (even numbered) -alkyl-1-aminium chloride is also considered as persistent in the environment, based on the results of a ready biodegradation test and the high log Kow value.

Therefore based on the a.m results N-benzyl-N-C16-18 (even numbered) -alkyl-N-methyl-C16-18 (even numbered) -alkyl-1-aminium chloride is classified as follows:

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

Acute M-factor = 1

Chronic M-factor = 1