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EC number: 233-864-4 | CAS number: 10401-55-5
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility (OECD 203).
Key value for chemical safety assessment
Additional information
Since no studies investigating the toxicity of hexadecyl (R)-12-hydroxyoleate (CAS 10401-55-5) to freshwater fish are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance dodecyl oleate (CAS 36078-10-1) was conducted. The read-across substance is representative to evaluate the toxicity of the target substance hexadecyl (R)-12-hydroxyoleate to fish. Based on the specification the target substance hexadecyl (R)-12-hydroxyoleate is mainly specified as an ester of a linear C16 alcohol and a C18:1(OH) fatty acid. The source substance is characterized by a similar alcohol (C12) and fatty acid component (C18:1). The smaller alcohol chain length increases the water solubility and therefore the bioavailability in the test medium since the water solubility is dependent on the C-chain length (Lide, 2005). However, the water solubility of all substances is very low (<0.7 mg/L at 24 °C for the target substance and < 0.05 mg/L at 20 °C for the source substance). This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue 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.
The study with the source substance dodecyl oleate was conducted 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 one structurally related source 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 hexadecyl (R)-12-hydroxyoleate will not exhibit short-term effects on freshwater fish up to the limit of water solubility.
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