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Long-term toxicity to fish

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The hazard assessment is based on the current data available. Based on the ECHA decision on a compliance check (decision number CCH-D-2114546485-42-01/F) from 14 April 2021 a long-term toxicity study on fish (OECD 210) is requested. The finalised study will be included into the dossier and the aquatic toxicity will be re-evaluated in the update of this dossier latest by 19 October 2022.

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Additional information

The hazard assessment is based on the current data available. Based on the ECHA decision on a compliance check (decision number CCH-D-2114546485-42-01/F) from 14 April 2021 a long-term toxicity study on fish (OECD 210) is requested. The finalised study will be included into the dossier and the aquatic toxicity will be re-evaluated in the update of this dossier latest by 19 October 2022.

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.