Registration Dossier
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EC number: 604-580-1 | CAS number: 147256-33-5
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the toxicity to soil microorganisms.
Key value for chemical safety assessment
Additional information
No tests with soil microorganisms are available for Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS No. 147256-33-5), but due to the ready biodegradability of the substance, chronic exposure of terrestrial microogranisms is unlikely. In addition, available data indicate, that the substance is not bioaccumulative and not toxic nor harmful to aquatic organisms. Based on the available information, toxicity to terrestrial organisms is not expected to be of concern. Furthermore, for Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS No. 147256-33-5) direct exposure can be excluded based on the use information, as presented in chapter 3.5 of the technical dossier. Therefore, there is no need for testing of soil organisms (Guidance on information requirements and chemical safety assessment, R7c, pg. 113, ECHA 2012).
Additionally, the low toxicity potential of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane on soil microorganisms is supported by further evidence from literature data. This data showed that soil microorganism communities are well capable of degrading fatty acid esters (Hita et al., 1996 and Cecutti et al., 2002) and use them as energy source (Banchio & Gramajo, 1997). Hita et al. investigated the degradation of the model molecule tristearin which is a triglyceride containing of glycerin tri-esterified with stearic acid in three different soils for 4 weeks. The amount of stearic acid increased in considerable amounts during the experiment showing the hydrolytic activity of lipases breaking the ester bonds. The investigation of ester fractions moreover showed the generation of new alkanoic acids (methyl stearate, ethyl stearate and propyl stearate) which were not determined in the controls. Nevertheless the amounts were no longer present after 4 weeks, which leads to the assumption that degradation by soil microorganisms had occurred. The same was shown by Cecutti et al. (2003). One soil sample was chosen and incubated with methyl oleate (plant oil) for 120 d. Methyl oleate and its metabolites were completely degraded after 60 d. Streptomyces coelicolor, a common gram-positive soil bacterium uses fatty acids (C4-C18) as sole carbon end energy source indicating that fatty acids are not-toxic and can be used for catabolism (Banchio and Gramajo, 1997). The available literature data shows that soil microorganisms are capable to break-up ester bonds and degrade fatty acids in significant amounts. Moreover, the data indicated the non-toxic properties of fatty acids since they can be used as energy source.
Based on the information above, terrestrial toxicity to soil microorganisms is not of concern for Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane. Thus, the generation of soil toxicity data is not required.
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