Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
50 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.083 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
9.4 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
11.11 mg/kg food
Assessment factor:
1 800

Additional information

PNECs for N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide were based on (i) new generated data and (ii) existing data. When no data is available the equilibrium partitioning method is used for determining the relevant PNEC. One long-term terrestrial test is available with a NOEC of 940 mg a.i. /kg dw. The chemical safety assessment indicates no need to investigate further.

Conclusion on classification

Dangerous substance directive:

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide is considered as very toxic for the aquatic compartment.

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide is considered as not-persistent in the environment, based on the results of a ready biodegradation test and additional research. This additional work showed that N

-[2-(piperazin-1-yl)ethyl]C18 -insaturated-alkylamide is quickly degraded to form 1 -aminoethylpiperazine which has a low calculated log Kow.

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide has a high log Kow value but due to the rapid degradation of the bioavailable fraction there will be no-accumulation of N-[2 -(piperazin-1 -yl)ethyl]18 -insaturated-alkylaminde in the food chain. It is anticipated that this rapid degradation will also occur in fish.

Therefore based on the above mentioned results N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide is classified as follows:

N-R50/53

Classification Labeling & Packaging:

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide is considered as very toxic for the aquatic compartment.

N-[2 -(piperazin-1 -yl)ethyl]C18 -insaturated-alkylamide is considered as non-persistent in the environment, based on the results of a ready biodegradation test and additional research.

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide has a high log Kow value but due to the rapid degradation of the bioavailable fraction there will be no accumulation of

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide in the food chain. It is anticipated that the observed rapid degradation of the bioavailable fraction will also occur in fish.

The chronic data available for

N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide are as follows: NOEC_algae (72h) = 0.011 mg/L and NOEC_daphnia (21d) = 0.37 mg/L

Therefore based on the above mentioned results and according to the new version of CLP (03.2011), N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide is classified as follows:

Aquatic acute category 1 - H400

Aquatic chronic category 2 – H411

The lowest L(E)C50 value obtained in the frame of the ecotoxicity tests being 0.037 mg/L (algae), the M factor is:

M-factor acute = 10

M factor chronic = 1