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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 (EU Method C.1; OECD 203).

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of (Z)-octadec-9-enyl oleate (CAS 3687-45-4) to fish are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the two structurally related category members dodecyl oleate (CAS 36078-10-1) and fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) was conducted. The read-across substance dodecyl oleate is characterized by the same fatty acid chain (C18 unsatd.) and a smaller fatty alcohol chain length (C12 compared to C18 unsatd. (target)). The second read-across substance fatty acids, C16-18, C12-18-alkyl esters is a UVCB substance covering (Z)-octadec-9-enyl oleate with its structural variability. This read-across is justified in detail in the overall summary (IUCLID section 6.1) and within the category 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 substance was used for the assessment. Nevertheless, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.

The first study conducted with the read-across substance fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) was performed according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio (Stelter, 1994). A static exposure regime was chosen. Three concentrations of nominal 1000, 3000 and 10000 mg/L were directly applied to the test vessels without a filtration step. Undissolved test material floated on top of the water surface but no effects were observed by the dissolved and even by the undissolved test substance present in the water. Thus, a LC50 (96 h) of > 10000 mg/L (nominal) was derived.

The second study with the read-across substance dodecyl oleate (CAS 36078-10-1) was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio (Hafner, 2013). A limit test with a Water Accommodated Fraction (WAF) of 100 mg/L (nominal) did not result in any mortality after 96 h. Thus, a LL50 (96 h) of > 100 mg/L was derived based on the nominal concentrations. The chemical analysis resulted in concentrations below the analytical detection limit of 0.005 mg/L reflecting the very low water solubility of the test item.

Based on the available result from two 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 (Z)-octadec-9-enyl oleate will not exhibit short-term effects to fish up to the limit of water solubility.