Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.96 µg/L
Assessment factor:
50
PNEC freshwater (intermittent releases):
9.4 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
7.3 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
5.8 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.58 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:
9.1 mg/kg soil dw
Assessment factor:
100

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Acute toxicity to fish: LC50 -96h = 0.94 mg/L (OECD 203)

Long-term toxicity to aquatic invertebrates: NOEC = 0.048 mg/L (OECD 211)

Toxicity to aquatic algae: ErC50 -72h = 1.17 mg/L and ErC10 = 0.32 mg/L (OECD 201)

Based on these results, Amides, C18-unsatd., N-[3-(dimethylamine)propyl]

is considered as very toxic to aquatic organisms. The substance is considered as non-persistent in the environment, based on the results of a ready biodegradation test. The substance has a high log Kow value but as a surfactant, this value can not be used to predict the sorption or bioaccumulation potential of this compound. But due to its rapid degradation, there will be no accumulation of Amides, C18-unsatd., N-[3-(dimethylamine)propyl] in the food chain. Indeed, it is anticipated that the observed rapid degradation of the bioavailable fraction will also occur in fish. Therefore based on the above mentioned results and according to the new version of CLP (03.2011), Amides, C18-unsatd., N-[3-(dimethylamine)propyl] is classified as follows: Aquatic acute category 1 - H400 (0.1<LC50<1 mg/L) M factor = 1 / Aquatic chronic category 1 – H410 M factor = 1. When chronic toxicity data are available these should be used for classification for chronic aquatic hazard. Considering the lower sensitivity of fish it is considered justified to use the long-term daphnia and algae test results for the chronic classification. The substance is readily biodegradable and the lowest NOEC/EC10 is 48 µg/L. Correcting this value for mitigation with the realistic worst-case correction factor of 10 leads to NOEC/EC10 for classification of 4.8 µg/L. Indeed, due to intrinsic properties of amine containing cationic surfactants river water ecotoxicity tests deliver reproducible test results with limited uncertainty. As river water has a mitigating effect on ecotoxicity due to sorption of the amines to and suspended matter a factor of 10 should be applied to the NOEC/EC10 to correct for the lower ecotoxicity observed.

And according to DSD, the substance is classified: R50/53.