Registration Dossier
Registration Dossier
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EC number: 271-694-2 | CAS number: 68604-44-4 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated tetralkyl carboxylic acid pentaerythritol tetraester and SDA Reporting Number: 11-016-00.
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key 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.
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 test to fish is proposed.
The available experimental studies on aquatic toxicity ofpentaerythritol (CAS 68604-44-4)for the two trophic levels (daphnia and algae) do not show any acute toxic effects up to the limit of water solubility. Furthermore, the long term test on the reproduction of daphnids conducted for the two category membersdecanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6)also do not reveal any adverse effects.Asthere was no sign that fish are the most sensitive species in the short term tests, it cannot be expected that a long-term test with fish will generate different results than the existing long-term test with invertebrates.Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish is required forfatty acids, C16-18 and C18-unsatd., tetraesters pentaerythritol (CAS 68604-44-4).In addition,due toits 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 offatty acids, C16-18 and C18-unsatd., tetraesters pentaerythritol (CAS 68604-44-4) to fish is unlikely and that it would not pose a higher risk to fish than it does to daphnids.
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