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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 for Daphnia magna (EU Method C.2)

Key value for chemical safety assessment

Additional information

There are no studies on aquatic invertebrate toxicity available for 2-ethylhexyl stearate (CAS No. 22047-49-0). The assessment of short-term toxicity was therefore based on studies conducted with the structurally most similar substances, for which data is available, isopropyl palmitate (CAS No. 142-91-6) and 2-ethylhexyl oleate (CAS No. 26399-02-0). This read across approach 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 category justification in Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was entered into IUCLID. Nevertheless, as can be seen in the data matrix of the category justification in Section 13, all reliable data in the category support the hazard assessment for this endpoint, by showing a consistent pattern of results.

The study with isopropyl palmitate (CAS No. 142-91-6), used as key study, was performed according to EU Method C.2 and GLP (Kirch, 1998). The test organism Daphnia magna was exposed to the test substance in a static system for 48 hours, at nominal test concentrations of 1000 and 3000 mg/L (measured initial concentrations 0.72 and 1.68 mg/L). No mortalities were observed at any of the test concentrations, and an EC50 of > 3000 mg/L was reported.

The key study with 2-ethylhexyl oleate (CAS No. 26399-02-0) was performed as a limit test, according to EU Method C.2 and GLP (Kuech and Wierich, 1995). The test organism Daphnia magna was exposed to the test substance in a static system for 48 hours, at the nominal test concentration of 100 mg/L. The test was performed with and without separation of undissolved test substance. With undissolved test substance present, immobilisation up to 100% occurred. However, this was probably due to physical effects caused by oil drops and the oil film floating on the surface, as described in the report. When the undissolved phase was separated, no effects were observed. It can, therefore, be concluded that the substance had no toxic effects on Daphnia up to the limit of water solubility.

Thus, based on theabove mentioned results, and due to the structural and profile similarities of the substances, as are explained with in the overall endpoint summary 6.1 it can be concluded that no toxicological short-term effects on aquatic invertebrates are expected up tothe limit ofwater solubility for 2-ethylhexyl stearate (CAS No. 22047-49-0).