Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
Long-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 long-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 to another structurally related substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted.
The study was performed according to the OECD Guideline 211 under GLP conditions. Daphnia magna was exposed to individually prepared Water Accommodated Fractions (WAF’s) of nominal 6.25, 12.5, 25, 50 and 100 mg/L under semi-static conditions. Analytical determination of test solution concentration resulted in very low concentrations of 0.03 mg/L in freshly prepared medium and concentrations below the detection limit of 0.01 mg/L before test medium renewal periods after every 48 or 72 h, respectively. After 21 d, no particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test resulting in an NOELR >= 100 mg/L.
Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is 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 chronic 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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