Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 210-826-5 | CAS number: 624-03-3
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-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 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-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 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.
Since no studies investigating the short-term toxicity to fish of ethane-1,2-diyl palmitate (CAS 624-03-3) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar category members propylene glycol diisostearate (CAS 68958-54-3) and ethylene distearate (CAS 627-83-8) was conducted.
The first study with the read-across substance 1-methyl-1,2-ethanediyl diisooctadecanoate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio (van Egmond, 1997). Five concentrations up to 100 mg/L were tested in a semi-static exposure regime. No effects were observed after an exposure of 96 h resulting in a LC50 > 100 mg/L.
The second read-across substance ethylene distearate was tested in limit test 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. Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that ethane-1,2-diyl palmitate will not exhibit acute effects to fish up to the limit of water solubility.
The assessment is based on the current data available. New studies, based on final decisions for this substance, will be conducted. The finalised studies will be included into the dossier and the aquatic toxicity will be re-evaluated in the update of this dossier latest by 22 July 2024.
See also the attached category concept document in chapter 13 showing an overview of the strategy for all substances within the glycol esters category.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
