Registration Dossier
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EC number: 287-824-6 | CAS number: 85586-21-6
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to limit of water solubility are expected (WS < 1 mg/L)
Key value for chemical safety assessment
Additional information
No experimental data evaluating the chronic toxicity of Fatty acids, C16-C18, methyl esters (CAS No. 85586-21-6) to aquatic invertebrates are available. Therefore, toxicity data from a structurally related category member, palmitic acid (CAS No. 57-10-3) are used as read-across in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Both substances are insoluble in water (palmitic acid, 0.04 mg/L (Robb, 1966); Fatty acids, C16-C18, methyl esters, < 1 mg/L) and have log Pow values > 5 (see IUCLID section 4.7; Amboise and Hanai, 1982), and therefore their behaviour in water is expected to be similar. Fatty acids, C16-C18, methyl esters is expected to be rapidly metabolized into the individual fatty acids (C16 and C18) and methanol (Fukami and Yokoi, 2012). Thus, the aquatic data available for palmitic acid (C16) is expected to give a proper indication of the toxicity of methyl palmitate to aquatic organisms. Due to its smaller size and weight with respect to the C18 component, it can be expected to be more bioavailable to aquatic organisms and therefore, serve as a good representation of the potential toxicity profile of this substance. Based on this information, it is justified to use the toxicity data from palmitic acid as read-across for Fatty acids, C16-C18, methyl esters.
One study evaluating the chronic toxicity of palmitic acid (CAS No. 57-10-3) to aquatic invertebrates is available (Ministry of Environment, Japan, 2008). This test was conducted according to OECD 211, under GLP conditions. Daphnids were exposed to the test substance for 21 days, within a semi-static water regime at a nominal concentration of 0.51 mg/L. Due to the low water solubility of the substance in water (0.004 mg/L), N, N-dimethyl formaldehyde (DMF) was used as solvent in the solution and test concentrations were determined by LC analysis. After 21 days of exposure, no significant effects were reported in reproduction or survival of the daphnids, and therefore the NOEC (21 d) was determined to be ≥ 0.22 mg/L (time weighed average measured concentration) and ≥ 0.51 mg/L (nominal).
Based on the results obtained for the structurally related category member (in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5), Fatty acids, C16-C18, methyl esters (CAS No. 85586-21-6) is not expected to show long-term toxicity to aquatic invertebrates up to the limit of its water solubility (< 1 mg/L).
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within the CSR.
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