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Toxicity to soil microorganisms

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Endpoint:
toxicity to soil microorganisms
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other justification
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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 soil microorganisms are available for Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7).

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).

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 soil microorganism 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 and no further test on soil microorganism is considered to be necessary.