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 assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. New studies with the registered substance and/or other member substances of the polyols 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. Thus, the strategy of terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available.
Additional information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. New studies with the registered substance and/or other member substances of the polyols 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. Thus, the strategy of terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available.
No experimental data evaluating the toxicity to soil organisms are available for Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2). The acute and chronic aquatic toxicity data available for a structurally related source substance determined no acute nor chronic toxic effects up to the water solubility limit indicating no selective toxicity for the aquatic compartment. In addition, the absence of chronic or long-term effects in aquatic organisms up to the water solubility limit, is a clear indicator to waive the data requirements of Annex X based on low intrinsic toxicity of the substance (Chapter R.7c: Endpoint specific guidance, 2017, page 148).
As a result of the high adsorption potential of the substance (Log Koc > 5) a removal from the water column to a significant degree by adsorption to sewage sludge can be expected (ECHA, 2017) and discharged concentrations of the substance into the soil compartment are likely to be negligible. Considering this one can assume that the availability of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) in the soil environment is very low, which reduces the probability of chronic exposure of soil organisms in general.
Furthermore, uptake is expected to be low based on the fact that the constituents of the substance are relatively large molecules (high molecular weight, size and structural complexity). With the high molecular weights (1853.05 g/mol) the substance is unlikely to be readily absorbed, due to the steric hindrance of crossing biological membranes. Following the ‘rule of 5’ (Lipinski et al., 2001), developed to identify drug candidates with poor oral absorption based on criteria regarding partitioning (log Kow > 5) and molecular weight (> 500 g/mol), the substance is considered to be poorly absorbed after oral uptake (also see Hsieh & Perkins, 1976). In addition, substances with log Kow values above 10, which has been calculated for the test substance, are considered to have a low bioaccumulation potential (e.g., Nendza & Müller, 2007; 2010). ). Overall, the bioaccumulation potential is negligible. For a detailed overview on bioaccumulation please refer to IUCLID section 5.3.1.
In conclusion, due to the absence of acute or chronic effects in aquatic organisms up to the water solubility limit, a removal from the water column to a significant degree by adsorption to sewage sludge, a low bioavailability, low expected uptake and a low bioaccumulation potential, no effects on terrestrial organisms are expected for Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2). As new aquatic studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future, the assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Thus, as soon as the new aquatic studies will be available, the strategy of terrestrial toxicity will be re-evaluated.
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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