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EC number: 500-204-4
CAS number: 68334-05-4
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.
No experimental data evaluating the toxicity Fatty acids, C18-unsatd.,
dimers, 2-ethylhexylesters (CAS No. 68334-05-4) to soil microorganisms
are available. However, information gathered from several independent
sources is combined in a Weight of Evidence approach, which is in
accordance to the REACh Regulation (EC) No. 1907/2006, Annex XI General
rules for adaptation of the standard testing regime set out in Annexes
VII to X, 1.2, to cover the data requirements of Regulation (EC) No.
1907/2006, Annex IX. This approach provides enough evidence to state
that this substance is unlikely to exert toxicity to soil microorganisms.
According to Chapter R7.b of the Guidance on information requirements
and chemical safety assessment (ECHA, 2012), a test on soil microbial
activity will be additionally necessary for a valid PNEC derivation only
if inhibition of sewage sludge microbial activity has occurred. The test
performed using activated sludge of a predominantly domestic sewage
showed no effects on respiration behavior up to a nominal concentration
of 100 mg/L (EC50 (3 h) > 100 mg/L). The above-mentioned Guidance also
states that for substances with a good biodegradation rate in a ready
biodegradability test, inhibitory effects to aquatic microorganisms are
not expected. This is the case for Fatty acids, C18-unsatd., dimers,
2-ethylhexylesters (62.1% biodegradation after 28 days).
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
Based on all the available information for the Weight of Evidence
approach (in accordance with Annex XI, 1.2) effects on soil
microorganisms are thus not expected to be of concern, and consequently,
no further testing is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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