Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
119 ng/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.19 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
11.9 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Short-term toxicity studies with freshwater fish, invertebrates and algae are available for the assessment of aquatic toxicity of the source substance Amides, C8-18, N-[3-(dimethylamino)propyl]. It can be expected that the results of these studies are applicable to the target substance Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl].

There are two EC50 values for the same species and end-point available thus the geometric mean was calculated for further PNEC estimation. The analysis of the test conditions was performed in order to find out why differences in response were present. The slight discrepancy in EC50 (∆ 0.067 mg/L) may result from the differences in test duration 24 h and 48 h as well as the purity of the test substance of 89.39 % and 91.2 %, respectively.

The most sensitive trophic level are the invertebrates (Daphnia magna) EC50 (24 h) = 0.09 mg/L (Acute toxicity test) and EC50 (48 h) = 157.2 µg/L (Acute immobilisation test).

In accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied and the PNEC aqua (freshwater) was derived from the EC50 value 118.95 µg/L, determined with Daphnia magna, the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 119 ng/L.

An assessment factor of 10000 was applied and the PNEC aqua (marine) was derived from the EC50 value of 118.95 µg/L. This results in a PNECaqua (marine) of 11.9 ng/L.

An assessment factor of 100 was applied to the EC50 = 118.95 µg/L. Thus, the PNECaqua(Intermittent release) was calculated to be 1.19 µg/L ng/L.

Conclusion on classification

According to GHS Regulation EC No 1272/2008 Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] is classified as acute aquatic hazard Category 1 with M-factor of 1 due to acute toxicity values </= 1 mg/L

Based on the 72 h EC10 in algae = 0.1 mg/L, the EC50 in Daphnia magna = 118.95 µg/L and the substance being readily biodegradable, Amides,

C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] is classified as Aquatic Chronic 2.

Labelling as H400 (Very toxic to aquatic life) and H411 (Toxic to aquatic life with long lasting effects) is required.