Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
Short-term toxicity to aquatic invertebrates
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 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.
Since no studies investigating the short-term toxicity to aquatic invertebrates 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 conducted to the two structurally related substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8).
The study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed with the water flea Daphnia magna according to the EU Method C.2 under GLP conditions as a limit test under static conditions. A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects on the mobility of the test organisms after 24 and 48 h. The analytically determined test concentration was 2.4 mg/L based on TOC-analysis. Thus, a EL50 of > 1000 mg/L was determined.
The second study using butylene glycol dicaprylate / dicaprate supports this result. It was conducted under the same conditions like the first study. Daphnia magna was exposed to a measured concentration (initial) of 2 mg/L in a static limit test for 48 h. The test concentration of 2 mg/L represents the highest soluble concentration, since 1 g/L was added to the test medium, stirred and subsequently filtered (WAF). No effects were observed, resulting in an EL50 of > 1000 mg/L.
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 toxic effects to aquatic invertebrates 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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