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Short-term toxicity to fish

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Description of key information

No effects up to the limit of water solubility (OECD 203).

Key value for chemical safety assessment

Additional information

Since no experimental studies investigating the short-term toxicity of fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) to fish 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 C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CASC 85005-23-8), 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 conducted according to OECD 203 (Bouillon, 2012). The zebra fish (Danio rerio) was exposed to the substance for 96 h in a static test system. No mortality was observed at the end of the exposure period and a LL50 (96 h) of > 102 mg/L was determined. The test results are based on the nominal concentration of the water accommodated fraction (WAF) of the test substance.

The second study with the read-across substance fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CASC 85005-23-8). This study was performed according to OECD 203 and EU Method C.1 with the carp Cyprinus carpio (Bogers, 1997). No lethal or other visible effects were observed within the tested concentration (100 mg/L nominal) during 96 h of exposure and a LC50 (96 h) of > 100 mg/L (nominal) was derived. As test substance drops floating at the surface of the medium, the tested concentration demonstrated a worst case.

The third study with the read-across substance 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis(isooctadecanoate) (CAS 68541-50-4) was conducted according to OECD guideline 203 (van Egmond, 1996). Zebra fish (Brachydanio rerio) were exposed to the test substance in a semi-static test system for 96 h. The test solution was renewed every 24 h and the substance concentration was determined analytically. At the end of the exposure period a LC50 (96 h) > 48 mg/L (NOEC (96 h) ≥ 48 mg/L) was determined based on the measured substance concentration.

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). The study was performed according to OECD 203 (GLP) using Oncorhynchus mykiss (Wetton and McKenzie, 2004). Fish 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 96 h no mortality was observed neither in the treatment nor in the solvent and test medium control resulting in a LC50 (96 h) > 0.2 mg/L (nominal) and > 0.106 mg/L (measured).

Based on the available results 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 fish up to the limit of water solubility.