Registration Dossier
Registration Dossier
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EC number: 701-177-3 | CAS number: -
Toxicity to terrestrial arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to terrestrial arthropods: long-term
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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
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.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). Thus, an invertebrates test for this substance is available and test with terrestrial arthropods is not required.
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 arthropods needs to be done.
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. 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.
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