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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

No effects up to the limit of water solubility for Brachydanio rerio (OECD 203)

Key value for chemical safety assessment

Additional information

Since no studies on fish toxicity are available for 2-ethylhexyl stearate (CAS No. 22047-49-0), the assessment was based on studies conducted with the structurally most similar category members, for which data is available, isopropyl palmitate (CAS No. 142-91-6) and 2-ethylhexyl oleate (CAS No. 26399-02-0), as part of a read-across approach, which 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 section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were 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 key study with isopropyl palmitate (CAS No. 142-91-6), was performed according to the guideline ISO 7346-1 (similar to OECD 203), in a semi-static system, using Brachydanio rerio as test organism (Richterich, 2001). The fish were exposed to nominal test concentrations of 1000, 3000 and 10,000 mg/L during 96 hours. No mortality was observed at any of the test concentrations, and the LC50 was reported to be > 10,000 mg/L.

The key study with 2-ethylhexyl oleate (26399-02-0) was performed according to OECD guideline 203 and GLP (Craig, 2002). The marine test organism Scophthalmus maximus was exposed to the test substance in a semi-static system for 96 hours, at nominal test concentrations of 320, 560, 1000 and 1800 mg/L. No mortality was observed at any of the test concentrations, and the LC50 was reported to be >1800 mg/L.

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