Registration Dossier
Registration Dossier
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EC number: 211-014-3 | CAS number: 627-83-8
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The hazard assessment is based on the data currently available. 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. 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.
Key value for chemical safety assessment
Additional information
The hazard assessment is based on the data currently available. 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. 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.
One experimental study investigating the short-term toxicity of ethylene distearate (CAS 627-83-8) to freshwater fish is available (Wetton, 1996). As it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.
The limit test was performed according to the OECD Guideline 203 under GLP conditions with the rainbow trout (Oncorhynchus mykiss). A semi-static test design was chosen. No effects were observed after 96 h resulting in a LC50 of > 0.3 mg/L (nominal). 0.3 mg/L was the highest concentration which was soluble in the solubiliser tetrahydrofuran without precipitation. No mortality was observed in the control and solvent control.
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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