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Toxicity to terrestrial plants

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In accordance with Regulation (EC) No. 1907/2006, Annex X, Column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that there is no need. The terrestrial toxicity of short chain fatty acid esters has been tested on the earth worm Eisenia fetida with the test substance isopropyl myristate (CAS No. 110-27-0). No mortality was observed during the 14-day exposure period at the test concentration of 20,000 mg/kg. Additionally, data is available on tests with terrestrial plants for the substance Fatty acids, C16-18 and C18-unsaturated, 2-ethylhexyl esters (CAS No. 85049-37-2). The 21-day NOEC value was 100 mg/kg for all plants tested, and EC50 values between 390 and 600 mg/kg are reported.

Based on the available data, the terrestrial toxicity of short chain fatty acid esters is very low. Additionally, the substances are not expected to remain in the terrestrial environment, due to ready biodegradation. Bioaccumulation is not likely due to rapid metabolism. Esters of primary alcohols, containing from 1 to 18 carbon atoms, with fatty acids, containing from 2 to 18 carbon atoms, are hydrolysed by pancreatic lipases. Measured rates of enzyme catalysed hydrolysis varied between 2 and 5 µeq/min/mg enzyme for the different chain lengths (Mattson and Volpenhein, 1972; and references therein). The resulting free fatty acids and alcohols are absorbed from the intestine into the blood stream. Fatty acids are either metabolised via the beta-oxidation pathway in order to generate energy for the cell or reconstituted into glyceride esters and stored in the fat depots in the body. The alcohols are metabolised primarily in the liver through a series of oxidative steps, finally yielding carbon dioxide (Berg et al., 2002; HSDB).

Available literature reports that the main route of excretion in rats is expected to be by expired air as CO2. The second route of excretion is expected to be by biliary excretion and the feces. Exemplarily, experimental data of ethyl oleate (is the ethyl ester of oleic acid) provided this assumption: 14C-labeled carbon of 5 mL/kg of ethyl oleate (CAS No. 111-62-6) was rapidly excreted in respiration CO2 (approximately 70%), faeces (7 -10%), and urine (1-2%), with essentially complete elimination by 72 hours after administration (Bookstaff, 2003).

Based on this information, toxicity to terrestrial arthropods is not expected to be of concern, and consequently, no further testing is required.



Berg, J.M., Tymoczko, J.L. and Stryer, L., 2002, Biochemistry, 5thedition, W.H. Freeman and Company

Bookstaff, R.C, Pai Bir, S., Bharaj, S.S., Kelm, G.R., Kulick, R.M., Balm, T.K., Murray, J.V. (2003) The safety of the use of ethyl oleate in food is supported by metabolism data in rats and clinical safety data in humans, Regulatory Toxicology and Pharmacology, 37, 133-148

Mattson, F.H. and Volpenheim, R.A. (1972): Relative rates of hydrolysis by rat pancreatic lipase of esters of C2-C18 fatty acids with C1-C18 primary n-alcohols,Journal of Lipid Research, 10, 1969