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EC number: 304-780-6
CAS number: 94279-36-4
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 investigating the effects on soil microorganisms
are available for the members of the PFAE aromatic category. 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 Annex VII -
The terrestrial toxicity of the PFAE aromatic category members has been
tested on the earth worm Eisenia fetida with the category member
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CAS
No. 90218-76-1). No mortality was observed during the 14-day exposure
period at the test concentration of 1,000 mg/kg soil dw. Additionally,
data is also available from a test with terrestrial plants for the same
substance. The 17-day EC50 value was > 100 mg/kg for all plants tested.
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. Since
the members of the PFAE aromatic category are considered to be enhanced
ultimately biodegradable by activated sludge microorganisms and show no
inhibitory effects on the growth of Pseudomonas putida up to a
concentration of 1000 mg/L, toxic effects on terrestrial microorganisms
Additionally, this assumption 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 is not of concern
for PFAE aromatic category members.
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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