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EC number: 246-625-4 | CAS number: 25111-05-1
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 (OECD 203), read across.
Key value for chemical safety assessment
Additional information
Since no studies investigating the short-term toxicity of 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2), Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) and Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) was conducted.
The target substance is characterized by C18 unsaturated fatty acid esterified trimethylolpropane (TMP) (mainly di- and triester). The selected source substances are structurally very similar to the target substance and are thus adequate for the assessment of short-term toxicity to fish. Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2) is characterized by C18, C18 unsatd fatty acids triesterified with TMP. Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) mainly consists of C18:1 FA triesterified with TMP. The third source substance Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) is characterized as a triester of TMP and C16-C18 and C18 unsatd. branched and linear fatty acids. 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.
Two semi-static studies, investigating the short-term toxicity to fish of the source substance Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2), are available. Both studies were conducted according to OECD 203. In the first study with Brachydanio rerio no mortality was observed at the tested concentration of 10000 mg/L (Kuttler, 1997). The LC50 (96 h) was determined as > 10000 mg/L (nominal) with highly turbidity at this concentration. In the second study with Salmo trutta the LC50 (96 h) was > 1000 mg/L (nominal) (Källqvist and Tobiesen, 1995). In this study a small amount of an emulsion was observed at the two highest concentrations (320 and 1000 mg/L) and some increase in turbidity was noted. Therefore, the highest tested concentrations in both studies demonstrated a worst case.
One static short-term test (Clemens, 1996) with Leuciscus idus melanotus, a freshwater fish, and one semi-static short-term test (Thomson, 2005) with Scophthalmus maximus, a marine fish, are available for the source substance for Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6). In both studies, performed similar to OECD 203 (GLP) no mortality was observed within the tested Water Accommodated Fractions (WAF) loading rates. Clemens determined a LL0 (96 h) ≥ 10000 mg/L and LL50 (96 h) > 10000 mg/L. Thomson observed a NOELR (96 h) ≥ 3200 mg/L and a LL50 (96 h) > 3200 mg/L. Both studies showed no mortality to freshwater and marine fish in the range of water solubility of the source substance.
One static GLP-study, investigating the short-term toxicity to freshwater fish of the source substance Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8), is available. This study (Bogers, 1997) with Cyprinus carpio according to OECD 203 determined a LC50 (96 h) of > 100 mg/L (nominal). No lethal or other visible effects were observed within the tested concentration (100 mg/L nominal) during 96 h of exposure. As test substance drops floating at the surface of the medium, the tested concentration demonstrated a worst case.
Based on the available result from several structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleatewill not exhibit short-term effects to fish up to the limit of water solubility.
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