Registration Dossier
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EC number: 203-966-3 | CAS number: 112-39-0
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility (WS = 0.004 mg/L)
Key value for chemical safety assessment
Additional information
No experimental data evaluating the chronic toxicity of methyl palmitate (CAS No. 112-39-0) 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 to Regulation (EC) No. 1907/2006, Annex XI, 1.5. Both substances are insoluble in water (palmitic acid, 0.04 mg/L (Robb, 1966); methyl palmitate, 0.004 mg/L) and have log Pow values > 7 (Kropp et al., 1997 (see IUCLID section 4.7); Amboise and Hanai, 1982), and therefore their behaviour in water is expected to be similar. Methyl palmitate is expected to be rapidly metabolized into the individual fatty acid (palmitic acid) and methanol (Fukami and Yokoi, 2012). Thus, the aquatic data available for palmitic acid is expected to give a proper indication of the toxicity of methyl palmitate to aquatic organisms. Acute studies conducted with fish species show comparable results (LC50 (96 h)= 550 mg/L (physical effects, above the water solubility of the substance)(CAS No. 112-39-0) and LC50 (96 h)> 6.9 mg/L (CAS No. 57-10-3, (CHRIP database, 2012)), indicating that both substances will exert no toxicity to fish. Based on this information, it is justified to use the toxicity data from palmitic acid as read-across for methyl palmitate.
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), no chronic toxicity to aquatic invertebrates up to the limit of water solubility of methyl palmitate is expected.
References
Amboise and Hanai (1982). Hydrophobicity and Retention in Reversed Phase Liquid Chromatography. Journal of Liquid Chromatography, 5(2), pp. 229-244
Fukami, T. and Yokoi, T. (2012). The Emerging Role of Human Esterases. Drug Metabolism and Pharmacokinetics, Advance publication July 17th, 2012.
Robb (1966). Determination of the aqueous solubility of fatty acids and alcohols. Australian Journal of Chemistry, 19(12), pp. 2281 - 2284
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