Registration Dossier
Registration Dossier
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EC number: 947-850-7 | CAS number: -
Toxicity to terrestrial arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to terrestrial arthropods: short-term
- Data waiving:
- other justification
- 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 according to OECD 222 (GLP) investigating the toxicity to earthworms with the source substance 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. Tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity as they allow potential uptake via surface contact, soil particle ingestion and porewater (ECHA, 2017). 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 2.17 – 4.08 (25 °C, 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 10 – 421.7 L/kg wet-wt (EPI Suite v4.11 and VEGA v1.2.3). 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 Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7) to terrestrial organisms.
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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