Registration Dossier
Registration Dossier
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EC number: 250-151-3 | CAS number: 30364-51-3
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil microorganisms
- 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
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.
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) has a low adsorption potential due to the low Log Koc of 2.2 – 2.5 (Franco & Trapp, 2008). In addition, the substance is determined to be readily biodegradable indicating a low potential for persistence. In addition, the substance has a low potential for bioaccumulation based on a log Kow of 1.35 (25 °C, Kowwin v1.68) and a log D of 1.52 at the environmentally relevant pH of 7. This conclusion is supported by the estimated log BCF values obtained by (Q)SAR, using the BCFBAF model v3.01, yielding a BCF of 3.16 L/kg wet-wt (regression-based estimate) and of 1.835 L/kg wet-wt (Arnot-Gobat, including biotransformation, upper-trophic). Furthermore, the substance is not classified for environmental hazards according to the Regulation (EC) No 1272/2008 (CLP) and following amendments (ATPs).
All available effect concentrations (EC/LC50) are > 1 mg/L. Thus, according to Guidance on information requirements and chemical safety assessment, R.7c (ECHA, 2017) Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) is in “Hazard category 1”. Therefore, in accordance with Annex IX, column 2 of Regulation (EC) No 1907/2006, in the absence of toxicity data for soil organisms, the equilibrium partitioning method has to be applied to assess the hazard to soil organisms. The PNEC (soil) was derived with the Equilibrium Partitioning Method (EPM) 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 organisms needs to be done.
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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