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EC number: 250-705-4
CAS number: 31566-31-1
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 Stearic acid,
monoester with glycerol (CAS No. 31566 -31 -1) 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
The test substance is characterized by a log Kow > 5, indicating
high potential for adsorption to soil particles. Tests with
soil-dwelling organisms that feed on soil particles are therefore most
relevant for the evaluation of soil toxicity of Stearic acid, monoester
with glycerol (Guidance on information requirements and chemical safety
assessment, Chapter R7.c (ECHA, 2012)). Soil invertebrates toxicity data
from a suitable read-across substance (Glycerides, C14-18 and C16-18
unsatd. mono-, di- and tri- (CAS No. No. 91052-28-7) in accordance with
Regulation (EC) No. 1907/2006, Annex XI, 1.5) are available. In this
test performed according to OECD 207, no effects on survival or biomass
of Eisenia fetida were reported, leading to a NOEC (14 d) ≥ 1000 mg/kg
dw (Moser, 2013).
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 on Pseudomonas putida (on a suitable
read-across substance, 1,2,3-propanetriyl trioleate (CAS No. 122-32-7))
showed no effects on cell multiplication up to a nominal concentration
of 0.8 mg/L (EC50 (18 h) > 0.8 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 Stearic acid, monoester with glycerol
(95% biodegradation after 28 days, read-across data).
Additionally, literature data evaluating the effects of fatty acid
esters, including one of the Glyceride category members (Glycerol
tristearate, CAS No. 555-43-1) to soil microorganisms are available.
Hita et al. (1996) investigated the degradation of the model molecule
tristearin (Glycerol tristearate) 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. Furthermore, the investigation of ester fractions 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. (2002) and Banchio and Gramajo (1997)
for other fatty acid esters. In the first test, one soil sample was
chosen and incubated with methyl oleate (plant oil) for 120 days. Methyl
oleate and its metabolites were completely degraded after 60 days.
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 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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