Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
18 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.18 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.8 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
18 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.028 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:
0.045 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The environmental classification of Bis-(N,N-dimethylaminoethoxyethyl)-methylamine (LE30) is currently not harmonized according to the CLP Regulation (EC) 1272/2008. Based on available acute aquatic toxicity data, the lowest valid effect concentration for freshwater aquatic organisms is 18 mg/L (ErC50 for algae). Based on the available acute data, the substance should not be classified for acute toxicity following Annex I, table 4.1.0 (a) of the CLP regulation (there are no acute values ≤ 1 mg/L). In the algal growth inhibition study, the NOErC for algae was 2.9 mg/L. No other long-term values are available, therefore the substance's classification for chronic toxicity should be determined based on the acute toxicity values, following Annex I, table 4.1.0 b (iii) of the CLP Regulation. Taking into account the acute toxicity data as well as the fact that the substance is not rapidly degradable and its log Kow is < 4, the substance should be classified as Aquatic Chronic 3 under the CLP Regulation.