Registration Dossier

Ecotoxicological information

Toxicity to terrestrial plants

Currently viewing:

Administrative data

Link to relevant study record(s)

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 toxicity testing with terrestrial organisms.

Key value for chemical safety assessment

Additional information

In accordance with Annex IX, column 2 of Regulation (EC) No 1907/2006, toxicity testing with terrestrial organisms does not need to be conducted as the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate a need for further investigations.

No experimental data on toxicity to terrestrial plants are available for of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3).

Due to a moderate potential for adsorption to particles present in soil, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3). In addition, invertebrates are the most sensitive organism in the aquatic compartment. No higher toxicity of the test substance is expected for terrestrial plants in comparison to soil macroorganisms.

A chronic test investigating the toxicity to earthworms according to OECD 222 with the test substance is available resulting in a NOEC (56 d) of 171 mg/kg dw for Eisenia andrei indicating low toxicity to terrestrial organisms.

The PNEC (soil) was derived with the result of the long-term toxicity test to soil macroorganism for evaluation of the PEC/PNEC ratio. This screening assessment indicates no risk for the terrestrial compartment (RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). Thus, according to Guidance on information requirements and chemical safety assessment, R.7c (ECHA, 2017), no toxicity testing for terrestrial plants needs to be done.

Moreover, exposure of the soil compartment is generally considered to be low. Even if exposed to the soil the substance is readily biodegradable indicating that it will not be persistent in the environment. Due to the low water solubility only low concentrations are expected in the pore water, which is the main exposure route for terrestrial plants. Exposure of plants to the substance is thus expected to be very limited. Therefore, tests with soil-dwelling organisms like the earthworm which allows potential uptake via surface contact, soil particle ingestion and porewater (ECHA, 2012), are most relevant for the evaluation of soil toxicity.

Thus, the available data investigating the toxicity to terrestrial macroorganisms are sufficient to assess the hazard of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) to terrestrial organisms.