Registration Dossier
Registration Dossier
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EC number: 246-625-4 | CAS number: 25111-05-1
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects on Daphnia magna up to the limit of water solubility (OECD 211), read-across
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity of 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane (CAS 68002-78-8) was conducted.
The target substance is characterized by C18 unsaturated fatty acid esterified trimethylolpropane (TMP) (mainly di- and triester). The selected source substance is structurally very similar to the target substance and is thus adequate for the assessment of long-term toxicity to aquatic invertebrates. Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane (CAS 68002-78-8) is characterized by C18 unsatd fatty acids triesterified with TMP. 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.
One study is available investigating the chronic toxicity of the source substance Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) to aquatic invertebrates. The study was conducted according to OECD 211 (Grell, 2013). Daphnia magna was exposed to the test substance in a semi-static test system. The test organism was exposed to a water accommodated fraction (WAF) of the test substance in a limit test (0.11 g/L). During the exposure period of 21 days the mortality and reproduction rate of the test organisms was recorded. The substance affected neither the survival rate nor the reproduction rate of D. magna. Based on the loading rate a NOELR (21 d) ≥ 0.11 g/L was determined.
Based on the available result from a structurally related read-across 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 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.
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