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EC number: 204-000-3
CAS number: 112-72-1
A reliable 72 h EC50 value of >1000 mg/kg dw soil (1.3%
organic carbon) has been determined for the effects of the test
substance on population numbers of the nematode Caenorhabditis elegans.
A reliable 7 d EC50 of >1000 mg/kg dw soil has been determine
for the effects of the test substance on population numbers of the earth
worm Eisenia fetida.
A reliable 7 d EC50 value of 530 mg/kg dw soil (1.3% organic
carbon) has been determined for the effects of the test substance on
population numbers of the Fulsomia candida.
These data are considered to be indicative only (non-assignable
reliability) and not suitable for quantitative application as part of
the chemical safety assessment.
Long term terrestrial toxicity
In accordance with Column 2 of REACH Annex X long-term terrestrial
toxicity testing is not needed as the chemical safety assessment
according to Annex I indicates that this is not necessary.
Moreover, considerable technical difficulties would be expected in the
conduct of such a test, due to the very rapid biotic removal of the
substance from the test system. Please refer to discussion of the
long-term aquatic invertebrate and fish studies, and evidence of rapid
removal in non-sterilised soils during method development for the
adsorption/desorption study with natural soils in the environmental fate
PNECsoil has been calculated from PNECfreshwater on the basis of the
equilibrium partitioning method; the risk characterisation ratio (RCR)
based on PNECsoil derived from this method is <1.
ECHA guidance on the integrated testing strategy and screening
assessment for soil (ECHA 2017, R.7c) indicates that this substance
falls into soil Hazard Category 3 (based on high potential for
adsorption (Log Kow >5), low persistence (readily biodegradable) and low
toxicity to aquatic organisms (EC 50 >1 mg/L)). This soil Hazard
Category would usually trigger screening assessment based on the
equilibrium partitioning method (EQPM) as well as a confirmatory
long-term soil toxicity test. However, the rapid degradation of the
substance means that long-term toxicity testing in soil is not possible.
The rapid degradation also indicates that the absolute quantity of
partitioning to soil is expected to be small. Therefore, terrestrial
hazard is based on the EQPM PNECs derived from the aquatic data.
Discussion of trends in the Category of C6-24 linear and
essentially-linear aliphatic alcohols:
The experimental data set for terrestrial toxicity across the category
is limited. There are no long-term data on the toxicity of LCAAs to
soil-dwelling organisms. However, the absolute quantity of partitioning
to soil is expected to be small, and rapid degradation is anticipated,
particularly in view of the rapid degradation seen in short-term studies
It is notable that significant technical difficulties were encountered
during method development for a recent study with decan-1-ol of
adsorption/desorption (OECD 106, Wildlife 2015) using natural standard
soils, in that it was not possible to detect sufficient substance and
establish equilibrium in non-sterilised soil samples. During method
development in preparation for this study, the laboratory reported that
after equilibration with soils for 15-minute to 24-hour periods,
decan-1-ol dosed into the test vessels was partly or completely
transformed into a more polar product, which was clearly distinguishable
from the starting material as clear and well separated peaks in the
chromatograms. The rate of transformation depends on the soil type. Only
after a very short (5-minute) equilibration the parent material remained
intact (personal communication, 8 January 2015 from Wildlife
International laboratory). Half-lives were not explicitly derived, but
chromatograms presented would indicate the half-life of decan-1-ol in
the soil test samples was approximately 30 min - 1 hour (silt loam
soil); 1 - 2 hours (loamy sand), and 15 - 30 minutes (clay loam). In
view of this, it is not technically feasible to attempt any further
terrestrial toxicity testing and the absence of existing long-term study
data is understandable.
Toxicity to micro-organisms
The terrestrial chemical safety assessment has been conducted using the
Equilibrium Partitioning method (EQPM). It is recognised that the
aquatic PNEC used in the EQPM does not take into account any indicator
for effects in aquatic microorganisms. However, analogous alcohols
within the Category are very rapidly biodegradable and show no
significant inhibitory effects on respiration of activated sludge or
specific microbial strains relevant to WWTP, at or above the limit of
solubility (based on inhibition tests and lack of toxicity in ready
biodegradability test). A lack of toxicity to soil microbiota was
suggested by a recent experimental finding associated with a recent
study of adsorption/desorption (OECD 106, Wildlife International, 2015)
using decan-1-ol. Significant technical difficulties were encountered
during method development for this study using natural standard soils,
in that it was not possible to detect sufficient substance and establish
equilibrium in non-sterilised soil samples. Therefore it is unlikely
that the PNECterrestrial based on aquatic ecotoxicity test results would
not be protective for terrestrial microorganisms. The chemical safety
assessment using EQPM does not suggest any unacceptable risks for the
Therefore, further toxicity testing with terrestrial microorganisms does
not need to be conducted.
Toxicity to birds
In accordance with Column 2 of REACH Annex X, studies on long-term or
reproductive toxicity to birds (required in section 9.6.1) do not need
to be conducted due to the availability of relevant existing data.
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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