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Long-term toxicity to aquatic invertebrates

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Description of key information

No effects up to the water solubility limit for Daphnia magna (OECD 211).

Key value for chemical safety assessment

Additional information

Since no studies on long-term toxicity to aquatic invertebrates are available for fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6), the assessment of chronic toxicity was based on studies conducted with the most similar source substances fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane (CAS 68002-78-8) and fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) as part of a read-across approach. The read-across is suitable due to the similar fatty acid chain length of both substances. This is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification is given within the endpoint summary 6.1 and within the analogue justification in IUCLID section 13.

The chronic toxicity of the read-across substance fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) to aquatic invertebrates was tested in a guideline study according to OECD 211 (Grell, 2013). Daphnia magna was exposed to the test substance in a semi-static test system. The test solution of a limit concentration of 0.11 g/L were prepared as water accommodated fractions (WAF). During the exposure period of 21 d the mortality and reproduction rate of the test animals 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.

For the second read-across substance fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) a long term toxicity test on aquatic invertebrates was proposed in order to confirm that no chronic toxicity to aquatic organisms occurs for the polyol esters with unsaturated fatty acid chain lengths. In particular, fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) was selected as a representative test substance for the chain lengths of the target substance, but it was also selected in order to cover saturated and branched C16/C18 chain lengths.

As soon as further chronic toxicity data for the read-across substance fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) becomes available the chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 will be updated accordingly. Based on the already available results 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 fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) will not exhibit long-term toxic effects on aquatic invertebrates up to the limit of water solubility.