Registration Dossier
Registration Dossier
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EC number: 284-864-6 | CAS number: 84988-75-0
Long-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-2114546485-42-01/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-2114546485-42-01/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.
No experimental data on long-term toxicity to fish are available for fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS 84988-75-0). The chemical safety assessment according to Annex I of Regulation (EC) 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed. Based on the available data, no effects were observed in short-term studies with fish and aquatic invertebrates. Moreover, no effects were observed in a chronic study with Daphnia magna according to OECD 211 (NOELR ≥ 0.02 mg/L) with the structurally related substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8). As there was no sign that invertebrates are less sensitive than fish in the short term tests, it can not be expected that a long-term test with fish will generate different results than the existing long-term test with invertebrates. Due to its ready biodegradability it is not likely that aquatic organisms are exposed to the test substance since it will be ultimately degraded in sewage treatment plants. Thus, based on the above mentioned results, it can be concluded that fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol, or any substance within the category does not show any chronic toxicity to fish up to the limit of water solubility. Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish is required for fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol.
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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