Registration Dossier
Registration Dossier
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EC number: 211-014-3 | CAS number: 627-83-8
Toxicity to terrestrial arthropods
Administrative data
Link to relevant study record(s)
Description of key information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546474 -45 -01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. Thus, the strategy for terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
The current hazard assessment is based on the presently available data.
Key value for chemical safety assessment
Additional information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546474 -45 -01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. Thus, the strategy for terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
The current hazard assessment is based on the presently available data.
In accordance with Regulation (EC) No. 1907/2006, Annex IX, column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that there is no need. No experimental data on toxicity to terrestrial arthropods are available for ethylene distearate (CAS 627-83-8). The test substance is characterised by a high log Koc indication a considerable potential for adsorption to the soil particles. Therefore, tests with soil-dwelling organisms that feed on soil particles are most relevant for the evaluation of soil toxicity of ethylene distearate.
Read-across in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 from structurally related category members butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) did not show any mortality to earthworms in acute tests according to OECD 207 and EU Method C.8, respectively (LC50 > 1000 mg/kg soil dw). A plant study with butylene glycol dicaprylate / dicaprate according to OECD 208 with three species from different taxonomic groups resulted in an EC50 of > 100 mg/kg soil for all tested species.
Moreover, the read-across substance butylene glycol dicaprylate / dicaprate did not show any chronic effects up to the limit of water solubility on the water flea Daphnia magna in a study according to OECD 211.
Since the substance is readily biodegradable, a chronic exposure of terrestrial organisms is not likely. Thus, acute tests with terrestrial organisms from different taxonomic groups in combination with chronic aquatic data indicating no effects up to the limit of water solubility are sufficient to assess the toxicity to terrestrial organisms.
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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