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EC number: 701-023-5
CAS number: 85408-61-3
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.
Experimental data on the toxicity of Fatty acids, C16-18 (even
numbered) and C18-unsatd., branched and linear, di- and triesters with
trimethylolpropane (former CAS 85005-23-8) to soil microorganisms are
not available. Generally, the TMP of the polyol esters category are
characterised by a high adsorption potential but also by ready
biodegradability. Acute effects to soil microorganisms are not expected
since the available data on toxicity of the TMP esters to aquatic
microorganisms indicates no detrimental effects. An inhibition of
respiration rate of aquatic microorganisms was not observed in the
available studies for the TMP ester group members. Data on a short-term
toxicity plant toxicity test according to OECD 208 available for fatty
acids, C16-18 (even numbered) and C16-18-unsatd. (even numbered),
triesters with trimethylolpropane (CAS 68002-79-9) indicate low toxicity
(NOEC 300 - 1000 mg/kg soil dw, LOEC 1000 mg/kg soil dw) to plants.
Nevertheless this data is insufficient for an accurate assessment as it
is not clear if this is related to phytotoxic or any physical effects
hence it must be disregarded and the assessment for terrestrial toxicity
can be based on the extensive available data for the polyol esters
A chronic exposure of terrestrial organisms is not probable since
the TMP esters of the polyol esters category are readily biodegradable.
Thus, they can be expected to be rapidly and ultimately degraded in the
terrestrial environment. When ingested by soil dwelling organisms, the
TMP esters are expected to be rapidly metabolised and thus an
accumulation and/or chronic effects are not likely. Two earthworm
reproduction tests according to OECD 222 are available for the TMP
bisheptanoate (CAS 78-16-0) and
(isooctadecanoate) (CAS 68541-50-4). In both studies no chronic toxicity
of the substances to Eisenia fetida was determined (Eisner, 2013). The
substances caused neither mortality nor a decrease in body weight of
adult earthworms. Also the reproduction rates were not affected by the
TMP esters and thus a NOECmort/repro ≥ 1000 mg/kg was reported in both
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
toxicity to soil microorganisms is not expected to be of concern.
Since the substance is readily biodegradable, it will be degraded
quickly. Thus, tests with terrestrial organisms from different taxonomic
groups in combination with chronic aquatic data and toxicity data on
microorganisms indicating no effects up to the limit of water solubility
are sufficient to assess that the TMP esters group members have a very
low toxicity to terrestrial organisms. 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. (1996) 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. Comparable results were demonstrated by
Cecutti et al. (2002). The authors incubated a soil sample 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 without adverse toxic effects occuring.
Therefore, as a part of a weight of Evidence (WoE) 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.
1907/2007, one can conclude from all available literature and data that
due to a) the observed absence of toxicological effects on aquatic
organisms, b) the lack of chronic exposure and c) the, acknowledged
metabolisation of fatty acid esters, terrestrial toxicity, and in
particular toxicity to soil microorganisms, is not of concern for TMP
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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