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Description of key information

EC10 and EC50 (16 h) > 10000 mg/L (nominal); read-across

Key value for chemical safety assessment

Additional information

Since no studies investigating the toxicity of2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) to aquatic algae 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 toxicity to activated sludge microorganisms. 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.

The study with the source substance Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2) was performed according to OECD 209 with domestic activated sludge (Kuttler, 1997). An increase of respiration rate of 20% at the tested concentration of 10000 mg/L (nominal) in comparison to the control was observed. No inhibition of respiration was observed. Therefore the EC10 and EC50 (3 h) were derived as > 10000 mg/L (nominal).

The second study with the source substance Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) investigated the toxicity to Pseudomonas putida (Clemes, 1996). This cell multiplication inhibition test according to DIN 38412 determined an EC10 and EC50 (16 h) > 10000 mg/L (nominal). No inhibition on the growth of Pseudomonas putida was observed at the tested nominal concentration of 10000 mg/L (clearly above the water solubility (< 1 mg/L)).

The same result was observed for 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). This study was performed using the same test conditions (Pateman, 1997).

Based on the available result from several structurally related read-across 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 dioleate will not exhibit effects to activated sludge microorganisms and the degradation process in sewage treatment plants will not be inhibited.