Registration Dossier
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EC number: 812-653-6 | CAS number: 68441-94-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No chronic toxic effects to fish up to the limit of water solubility (< 1 mg/L) are expected.
Key value for chemical safety assessment
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 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. Experimental studies for long-term toxicity to aquatic invertebrates for structurally similar category members 2,2-bis[[(1-oxopentyl) oxy]methyl]propane-1,3-diyl divalerate (CAS 15834-04-5) and tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol (CAS 68424-31-7) are planned. These studies together with 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) and a 21 day-long-term study with Daphnia magna (Schlechtriem, 2013) for fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) 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 reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (former CAS 68441-94-1).
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.
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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