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Long-term toxicity to fish

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No experimental data on long-term toxicity to fish are available for 2-hydroxyethyl palmitate (EC n°224-160-8), nor chemical safety assessment according to Annex I of Regulation (EC) 1907/2006. However, a such chemical safety assessment according to Annex I of Regulation (EC) 1907/2006 is available for Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1), structurally very close to 2-hydroxyethyl palmitate (EC n°224-160-8). This chemical safety assessment 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 read-across 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 inherent 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  2-hydroxyethyl palmitate (EC n°224-160-8), 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  2-hydroxyethyl palmitate (EC n°224-160-8).

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