Registration Dossier
Registration Dossier
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EC number: 286-056-9 | CAS number: 85186-72-7
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility.
Key value for chemical safety assessment
Additional information
Since no studies investigating the short-term toxicity of Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) was conducted. The source substance is representative to evaluate the short-term toxicity of the target substance to fish. The target substance is mainly characterized as a tetraester of pentaerythritol and C16-C18 branched, saturated and unsaturated fatty acids. The source substance 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) is a tetraester of pentaerythritol and mainly C18 branched fatty acids as well as fatty acids of C14-C22.
This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.
The experimental study with the source substance 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) investigated the short-term toxicity to freshwater fish under semi-static conditions using Danio rerio according to OECD 203. The study was conducted under semi-static conditions. Nominal concentrations of 10, 18, 32, 56 and 100 mg/L were applied. A stock solution was prepared daily and diluted appropriately. No mortality occurred after the test duration of 96 h resulting in an LC50 of > 100 mg/L.
Based on the available results from a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol will not exhibit short-term effects to fish up to the limit of water solubility.
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