Registration Dossier
Registration Dossier
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EC number: 701-177-3 | CAS number: -
Toxicity to terrestrial plants
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). A chronic test according to OECD 222 (GLP) investigating the toxicity to earthworms with N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) is available resulting in a NOEC (56 d) of 171 mg/kg dw for Eisenia andrei.
The PNEC soil was derived with the NOEC from the long-term toxicity test with soil macroorganisms (Eisenia Andrei, OECD 222), as this is the most realistic value for evaluation of terrestrial toxicity. Thus, the PNEC soil based on experimental data was used 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. 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.
Moreover, due to calculated Log Koc values (Log Koc of 1.93 – 3.37 (pH 4 – pH 9, Franco, Fu and Trapp)), a low to moderate potential for adsorption to particles is expected in soil. Even if exposed to the soil the substance is readily biodegradable indicating that it will not be persistent in the environment. Furthermore, the substance has a low potential for bioaccumulation (see chapter 5.3.1), i.e. based on log D < 4.5, metabolisation and excretion and 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). Thus, the substance is not expected to bioaccumulate in terrestrial organism.
Due to the water solubility of 0.44 mg/L only low concentrations are expected in the soil pore water, which is the main exposure route for terrestrial plants. Exposure of plants to the substance is thus expected to be limited. Therefore, tests with soil-dwelling organisms like the earthworm which allows potential uptake via surface contact, soil particle ingestion and porewater (ECHA, 2017), are most relevant for the evaluation of soil toxicity of this substance.
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 and no further test on terrestrial plants is considered to be necessary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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