Registration Dossier

Ecotoxicological information

Toxicity to soil microorganisms

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 microorganism 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).

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 this 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 microorganism 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.

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.