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Long-term toxicity to fish

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Description of key information

No chronic toxic effects to fish up to the limit of water solubility (< 1 mg/L) is expected, however a further long term toxicity test to aquatic invertebrates for tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol (CAS 68424-31-7) is planned.

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Additional information

The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordanceto Annex IX, column 2 no further long-term toxicity testing to fish is proposed.

The available experimental studies on aquatic toxicity for all members of the polyol esters category and in particular those which were chosen as suitable read across all show that on all three trophic levels no acute toxic effects up to the water solubility occur. Furthermore the available data on the long term toxicity of aquatic invertebrates does not reveal adverse effects to daphnids.Further experimental studies for long-term toxicity to aquatic invertebrates for tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol (CAS 68424-31-7), 2,2-bis[[(1-oxopentyl) oxy]methyl]propane-1,3-diyl divalerate (CAS 15834-04-5), tetraesters from esterification of pentaerythritol with pentanoic, heptanoic and isononanoic acids (CAS 68424-30-6) andfatty acids, C8, C10, C12, C14, C16 esters with pentaerythritol, reaction product of coconut oil fatty acids, C8-10 fatty acid mix and pentaerythritol (CAS 85049-33-8)are planned.

These studies together with a 21 day-long-term study with Daphnia magna (Letinski and Bragin, 2012) for decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and a 15 day-long-term study with Daphnia magna (Low, 1996) for fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) will provide sufficient evidence for the chronic ecotoxicity of this substance.

Moreover, as there was no sign that fish are the most sensitive species in the short term tests, one can expected that a long-term test with fish will not generate different results than the existing long-term test with Daphnia. Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish is required for pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS 68424-31-7). In addition, 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. Therefore, it can be concluded that chronic exposure of this substance to fish is unlikely and that it would not pose a higher risk to fish than it does to daphnids.