Registration Dossier
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EC number: 285-207-6 | CAS number: 85049-37-2
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects on acute toxicity to invertebrates up to the limit of water solubility.
Key value for chemical safety assessment
Additional information
No studies on the toxicity to freshwater invertebrates were available for Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS 85049-37-2). The assessment was therefore based on studies conducted with the category members 2-ethylhexyl oleate (CAS No. 26399-02-0) and Fatty acids, C8-16, 2-ethylhexyl esters (135800-37-2), 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 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 2-ethylhexyl oleate (CAS No. 26399-02-0) was performed according to the EU-method C.2 considering the VCI concept draft for the acute testing of poorly soluble substances from 1994-01-31 for 48 h (Kuech and Wierich 1995).The first approach without removal of the insoluble particles resulted in immobilization rates between 0 and 100% (mean: 25%). After removal of insoluble particles (filtration) no effects to Daphnia magna were observed. Thus, it can be stated that the insoluble particles of the test substance resulted in negative physical effects to the test species (e.g. agglutination of gills). No effects in the range of water solubility were observed. This resulted in an EC50 (48h) > 100 mg/L (nominal).
The second key study with Fatty acids, C8-16, 2-ethylhexyl esters (135800-37-2) was performed according to the EU-method C.2 under GLP conditions (Wierich 1998).Different preparation methods of test solution with dilution water were applied and tested on Daphnia magna. Effects on mobility of the daphnids (about 50 %) were reported for the medium which contained 100 mg/L test substance without further separation of the undissolved test substance (measured concentration at the start of the test: 12.41 mg/L). After filtration of the test solution no effect on mobility was stated (measured concentration at the start of the test: 0.04 mg/L). Similarly to the first read across, these results confirmed the statement, that the observed effects are most likely physical and not systemic effects. The resulting EC50(48h) was reported as >100 mg/L (nominal).
A supporting study on the marine species Acartia tonsa, tested as WAF, reported an EL50(48h) > 2047 (1646-2470) mg/L (Hudson 2000).
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