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Short-term toxicity to aquatic invertebrates

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Description of key information

No effects up to the limit of water solubility (OECD 202).

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) to aquatic invertebrates are available for this endpoint, 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 and C18 unsatd., triesters with trimethylolpropane (CAS 68002-78-8), Fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9), 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis(isooctadecanoate) (CAS 68541-50-4) and fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was conducted. 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 substances were used for the assessment.

The first study with the read-across substance fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) was performed according to OECD 202 (Bouillon, 2012). Daphnia magna was exposed to the test substance in a static test system for 48 hours. The test was performed as a limit test with a loading ratio of 0.106 g (substance)/1000 g (test medium). An EL50 >106 mg/L based on the nominal concentration of the water accommodated fraction of the test substance was reported.

The second study with the read-across substance fatty acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9). This study was performed according to OECD 202 (Gode & Mühlberg, 2002). No effects on mobility were observed and an EC50 (48 h) > 1000 mg/L (nominal) was determined.

The third study with the read-across substance 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis(isooctadecanoate) (CAS 68541-50-4). The study was performed according to OECD 202 (Marshall, 1996) with measured test concentrations up to 7.6 mg/L (measured). No effects on mobility were observed after 48 h resulting in an EC50 (48 h) > 7.6 mg/L.

The fourth study with the read-across substance fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was performed according to OECD 202 (GLP) using the water flea Daphnia magna (Wetton and McKenzie, 2004). Daphnids were exposed to a nominal limit concentration of 0.2 mg/L prepared in acetone. This concentration reflects the maximum concentration soluble in water. Preliminary experiments which are documented in the study report showed that higher concentrations lead to turbid test solutions which may affect the outcome of the study (e.g. physical effects by insoluble particles). The test substance concentration was verified analytically by HPLC/UV-Vis. After an exposure of 48 h no mortality was observed neither in the treatment nor in the solvent and test medium control resulting in an EC50 (48 h) of > 0.2 mg/L (nominal) and > 0.095 mg/L (meas. TWA).

Based on the available experimental studies from four 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 fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) will not exhibit short-term effects on aquatic invertebrates up to the limit of water solubility.