Registration Dossier
Registration Dossier
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EC number: 615-229-7 | CAS number: 70969-57-2
Endpoint summary
Administrative data
Description of key information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
Additional information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
There are no ecotoxicological data available for Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2). Therefore, read-across in compliance with Annex XI, 1.5, of Regulation (EC) No 1907/2006 to the structurally related substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) was conducted in order to fulfil the standard information requirements. 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 as suitable representative for the assessment of the short-term toxicity to fish, long-term toxicity to aquatic invertebrates and toxicity to microorganisms of the target substance. All experimental studies available for the source substance were performed according to internationally accepted guidelines. The short-term toxicity to fish was determined in a study according to OECD guideline 203 for the source substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6). No effects were observed up to the limit of water solubility.
The chronic toxicity of the source substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to Daphnia magna was tested in a semi-static study according to OECD 211 (GLP). A NOEC (21 d) of ≥ 100 mg/L was determined. Thus, no effects on survival or reproduction rate of the daphnids were observed up to the limit of water solubility.
Data on toxicity to algae are not available. However, according to Regulation (EC) No 1907/2006, Annex VII, 9.1.2., column 2, toxicity testing with aquatic algae does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes. Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is poorly soluble in water (< 1.7E-4 mg/L) and has a high molecular weight (average of substance components: 1853.05 g/mol) indicating that crossing biological membranes is unlikely. Moreover, the available acute and chronic toxicity tests demonstrate that toxic effects of the substance up to the limit of water solubility are unlikely.
The toxicity to microorganisms was assessed using the toxicity control of the biodegradation test (OECD 301B) for Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6). The toxicity control attained 26.7% degradation after 5 days of incubation (40.9% after 14 d). Hence, the substance is not toxic to aquatic microorganisms in the toxicity control and a NOEC (14 d) ≥ 20 mg/L was derived.
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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