Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
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-2114546451-53-01/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-2114546451-53-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 19 October 2022 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 Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across was conducted to the two structurally related substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and propylene glycol diisostearate (CAS 68958-54-3).
The study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed as a limit test according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio under semi-static conditions. A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since they were oversaturated, whereas the effect concentration was based on the nominal values. Thus, a LL50 of > 1000 mg/L was determined.
The second study with the read-across substance propylene glycol diisostearate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio. 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 (nomimal). 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 Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) will not exhibit acute effects to fish up to the limit of water solubility.
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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