Registration Dossier
Registration Dossier
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EC number: 263-193-2 | CAS number: 61791-59-1
Endpoint summary
Administrative data
Description of key information
Additional information
Reliable ecotoxicological data are available for Glycine, N-methyl-, N-coco acyl derivatives, sodium salts (CAS 61791-59-1) investigating the short-term toxicity to fish, to aquatic invertebrates and toxicity to activated sludge microorganisms. There is no data available determining the toxcicity to aquatic algae for the target substance. Therefore, read-across in compliance with Annex XI, 1.5, of Regulation (EC) N° 1907/2006 to the structurally related substances Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3)was conducted for toxicity to aquatic algae in order to fulfil the standard information requirements according to Annex VIII of Regulation (EC) No 1907/2006.. Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substance, the source substance is considered suitable representative for the assessment of the aquatic toxicity of the target substance. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
All experimental studies available for the target and the source substance were performed according to internationally accepted guidelines. They cover all three trophic levels of an aquatic ecosystem.
The short-term toxicity to fish was determined in a GLP-study according to OECD 203. Danio rerio was exposed to the target substance for 96 h resulting in a LC50 (96 h) = 14.4 mg/L (nominal).
The short-term toxicity to aquatic invertebrates was determined in a GLP-study according to OECD 202. Daphnia magna was exposed to the target substance for 48 h resulting in an EC50 (48 h) = 10.0 mg/L (nominal).
The toxicity to aquatic algae was tested in a study according to OECD 201 (GLP) for the source substance Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3). The freshwater algae Pseudokirchneriella subcapitata was exposed for 72 h. An EC50 (72 h) of 13.47 mg/L (nominal) and an ErC10 (72 h) of 4.448 mg/L (nominal) was determined.
The toxicity to microorganisms was assessed in a GLP-study according to OECD 209 with activated sludge as inoculum with the target substance. After 3 h a NOEC of ≤ 1000 mg/L (nominal) was determined.
Based on the structural similarity and comparable physico-chemical properties between the target and source substance, the target substance is expected to exhibit a similar ecotoxicological profile as the source substance for the respective endpoint read-across was applied for. All the reliable data compiled in the data matrix of the analogue justification in IUCLID section 13 supports the read-across approach by showing a consistent pattern of results.
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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