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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 CAS 15834-04-5 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 accordance to 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 for 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate (CAS-No.15834-04-5) 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. An experimental study for long-term toxicity to aquatic invertebrates for 2,2-bis[[(1-oxopentyl) oxy]methyl]propane-1,3-diyl divalerate (CAS-No. 15834-04-5) is planned. This study 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.No. 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 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate (CAS-No.15834-04-5). 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.