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EC number: 306-232-1
CAS number: 96690-38-9
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 investigating the effects on soil
microorganisms are available forthe LCAE category members.Therefore, all
available related data is combined in a Weight of Evidence (WoE)
approach, which is in accordance to the REACh Regulation (EC) No
1907/2006, Annex XI, 1.2, to adapt the data requirements of Regulation
(EC) No 1907/2006 Annex VII - X (ECHA guidance section R.22.214.171.124, page
The LCAE category members are characterized by a high log Koc (>
5) indicating a potential for adsorption to the soil particles. Tests
with soil-dwelling organisms that feed on soil particles are therefore
most relevant for the evaluation of soil toxicity of the LCAE category
members. In the absence of a clear indication of selective toxicity, an
invertebrate (earthworm or collembolan) test is preferred, as outlined
in ECHA guidance section R.126.96.36.199, page 122.
Studies for the category members Fatty acids, C8 - 10, C12 -
18-alkyl esters (CAS 95912-86-0) and 2-octyldodecyl isooctadecanoate
(CAS 93803-87-3) according to OECD 222 investigating the long-term
toxicityto earthworms resulted in low
toxicity (NOEC (56 d) 500 mg/kg soil dw and ≥ 1000 mg/kg
soil dw, respectively).
Available reliable data for toxicity to aquatic microorganisms for
the LCAE category members supports the determination of a lack of
toxicity to soil microorganisms. No inhibition of respiration rate of
aquatic microorganisms was observed in any of the available studies for
the LCAE category members. The Guidance Document (ECHA, 2012, page 122)
states that a test on soil microbial activity will only be additionally
necessary for a valid PNEC derivation if inhibition of sewage sludge
microbial activity has occurred and this is clearly not the case. Since
the LCAE category members are readily biodegradable, they will be
degraded quickly. This 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. 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.
Taking all the available information into account in a 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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