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EC number: 204-000-3
CAS number: 112-72-1
Bioconcentration factor in fish: low (BCF = 190-1000), estimated using
No reliable guideline-standard measured
bioconcentration studies are available for tetradecan-1-ol. In
accordance with Section 2 of REACH Annex XI, the study does not need to
be conducted because guideline-standard studies of bioaccumulation in
fish would be confounded by the technical difficulties of maintaining
the test substance in solution. As was demonstrated in the long-term
studies of effects of close structural analogues in invertebrates (see
Section 6.1.4), severe difficulties were encountered in conducting the
study due to biodegradation (including metabolism) of the test
substances in the test system was almost complete within the 24 h test
media renewal period. Similarly the long-term study in fish conducted
with the structurally analogous alcohol decan-1-ol required substantial
method development work to overcome severe difficulties maintaining the
test substance in the test system (see Section 6.1.2).
There is no requirement in REACH to conduct
any secondary poisoning assessment, in view of the consistent lack of
systemic toxic effects of the alcohols across this category to mammals.
In addition, the rapid biodegradation of the substance, combined with
evidence of rapid metabolism in fish, mammals and micro-organisms
(Mankura et al. 1987), and see Sections 7.1, 6.1.4), suggest that it is
unlikely that bioaccumulation would be seen in studies.
A BCF value of 190 (log Kow-based
regression) and 670-1000 (Arnot-Gobas method incorporating metabolic
transformation) has been calculated using EPI BCFBAF v3.01 (2012). This
model uses a log Kow-based equation with modified algorithms
for specific structural features. This version of the software also
incorporates for the first time a modification for biotransformation in
vivo. These considerations suggest that it is unlikely that
bioaccumulation would be exhibited in nature.
Discussion of trends in the Category
of C6-24 linear and essentially-linear aliphatic alcohols:
All the reviewed data indicate that log Kow-based
QSARs overestimate BCF because they take no account of biotransformation
and metabolism of alcohols by a wide range of biota from bacteria to
mammals (Veenstra et al., 2009; Mudge, 2008). These observations
have recently been critically assessed using cellular biotransformation
assays of ethoxylated alcohols and other aliphatic surfactants which
confirm that metabolism of the alkyl chain can lower BCF by orders of
magnitude (Dyer et al., 2008; Cowan-Ellsberry et al.,
2008). For the more soluble chain lengths, evaluated in non-guideline
BCF studies on linear alcohols and guideline studies for branched
alcohols, predicted BCFs are overestimated by at least an order of
magnitude (Fisk et al., 2012).
Values predicted for 2-methyl branched
alcohols are fairly consistent with the predicted values for the linear
structures of the same carbon number based on BCFBAF v3.01 estimates,
with small variations only associated with small margins of variation in
the log Kow value. The presence of branched constituents is
therefore not expected to significantly affect the predicted values;
multiply-branched alcohols have been demonstrated to be metabolised
ca. 2.5 times less efficiently by pig liver enzyme homogenate than
linear structures of the same carbon number (Menzel et al., 2001,
in which different isomeric forms of C12 saturated alcohols were studied
as well as C14 linear alcohol), but a single branch is unlikely to have
a significant impact.
For the multi-constituent/UVCB long chain
alcohols, a single BCF value is difficult to predict. However the values
for the constituents present are relevant. There is ample experimental
in vivo evidence of metabolism in various trophic levels. Rapid
biotransformation into tissue lipids has been demonstrated by Mankura et
al. 1987 in fish (carp), for oleyl alcohol (C18, unsaturated).
Biotransformation of linear structures has been demonstrated to be
faster than for multiply-branched structures (Menzel et al.,
2001) in accordance with expectations based upon the metabolic pathways.
Predicted bioconcentration factors, using methods which take account of
the expected metabolism in vivo, estimate low BCF values. Experimental
studies using structural analogues show low BCF values. All linear
alcohols in this chain length range are readily biodegradable in
reliable standard studies.
BCF can be calculated using EPI BCFBAF v3.01
(2012). This model uses a log Kow-based equation with
modified algorithms for specific structural features. This version of
the software also incorporates for the first time a modification for
biotransformation in vivo. These considerations suggest that it
is unlikely that bioaccumulation would be exhibited in nature for
alcohols in the C6-24 linear and essentially-linear alcohols category.
It is therefore concluded that the
long-chain alcohols in this category are non-bioaccumulative. This
conclusion is considered to be sufficiently well-supported to justify no
need for further testing in fish, since vertebrate testing for the
purposes of REACH registration should be avoided where adequate existing
evidence exists, and in view of the expected severe technical
difficulties in conducting such a test.
Further information can be found in the
attached position paper.
Cowan-Ellsberry, C.E., Dyer, S.D., Erhardt,
S., Bernhard, M.J., Roe, A.L., Dowty, M.E., Weisbrod, A.V., 2008.
Approach for extrapolating in vitro metabolism data to refine
bioconcentration factor estimates. Chemosphere 70, 1804–1817.
Dyer, S.D., Bernhard, M.J.,
Cowan-Ellsberry, C., Perdu-Durand, E., Demmerle, S., Cravedi, J.-P.,
2008. In vitro biotransformation of surfactants in fish. Part I: Linear
alkylbenzene sulfonate (C12-LAS) and alcohol ethoxylate (C13EO8).
Chemosphere 72, 850–862.
Peter Fisk Associates Limited (2012)
Position paper: Bioaccumulation of Aliphatic Alcohols in the context of
REACH registration. Reference: PFA.197.018.002. Date: 10 August 2012.
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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