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Ecotoxicological information

Sediment toxicity

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Endpoint:
sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the toxicity to sediment organisms.

Key value for chemical safety assessment

Additional information

N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) has a log Kow of ≥3.5≤4.2 at 20°C (EU A.8, HPLC method) and a log Koc of 1.93 – 3.37 (pH 4 – pH 9, Franco, Fu and Trapp). Thus, the potential to adsorb or bind onto sediment is expected to be low to moderate. According to the Guidance on information requirements and chemical safety assessment, R.7b (ECHA, 2017) the equilibrium partitioning method (EPM) can be applied as a first screen to derive the PNEC sediment, in order to conduct a screening risk assessment for the sediment compartment (PEC/PNECsed). As the environmental exposure assessment indicates no risk for the sediment compartment (all Risk Characterisation Ratios (RCR) < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information), no risk for the sediment compartment is indicated and further tests are not needed.

In addition, the substance is considered to be readily biodegradable and according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b (ECHA, 2017), readily biodegradable substances can be expected to undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs). Therefore, this substance has a low potential for persistence and chronic exposure of sediment organisms is unlikely.

Based on the aquatic toxicity data, N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) is classified as Aquatic Acute 1 and Aquatic Chronic 3 according to CLP. Sediment testing is not relevant for classification purposes and thus no change in classification is triggered by sediment data. Since no high adsorption or binding behavior to sediment particles is expected and the all RCR’s are < 1, no risk for the sediment compartment is indicated and no further testing is considered necessary.

Moreover, the bioaccumulation potential of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) is expected to be low i.e. based on log D of 3.52 and 3.55 (pH 7), excretion processes and low BCF values of 95.39 – 264.5 L/kg wet-wt (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic) and 3.16 L/kg wet-wt (regression-based method; for all three constituents and both log Kow values) based on QSAR. Therefore, this substance has a low potential for persistence and chronic exposure of sediment organisms is unlikely.

Based on the low adsorption potential, a RCR < 1, low bioaccumulation potential and low potential for persistence, it can be concluded that N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) is not expected to be harmful to sediment organisms.