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EC number: 500-204-4
CAS number: 68334-05-4
Justification for grouping of substances and read-across
There are no data available the toxicity to reproduction of Fatty
acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4). In
order to fulfil the standard information requirements set out in Annex
X, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No
1907/2006, read-across from structurally related substances was
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006,
"information on intrinsic properties of substances may be generated by
means other than tests, provided that the conditions set out in Annex XI
are met.” In particular for human toxicity, information shall be
generated whenever possible by means other than vertebrate animal tests,
which includes the use of information from structurally related
substances and/or common chemical precursors or similar
hydrolysis/breakdown products (grouping or read-across).
Having regard to the general rules for grouping of substances and
read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC)
No 1907/2006 whereby substances may be predicted as similar provided
that their physicochemical, toxicological and ecotoxicological
properties are likely to be similar or follow a regular pattern as a
result of structural similarity and/or common chemical precursors or
similar hydrolysis/breakdown products.
The read-across is either based structural similarity or on the
metabolism of Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS
68334-05-4), in particular on the fact that the substance undergoes
enzymatic ester hydrolysis resulting in the formation of Fatty acids,
C18-unsatd., dimers and 2-ethylhexanol. A detailed analogue approach
justification is provided in the technical dossier (see IUCLID Section
Endpoint specific data matrix:
Short term toxicity to fish
Long term toxicity to fish
Short term toxicity to aquatic invertebrates
Long term toxicity to aquatic invertebrates
Toxicity to aquatic algae
Toxicity to microorganisms
Experimental result:LL50 > 100 mg/L
Experimental result:EL50 > 100 mg/L
Experimental result:NOEC ≥100 mg/L
NOEC ≥ 0.85 mg/L
Acute tests evaluating the toxicity of of Fatty acids, C18-unsatd.,
dimers, 2-ethylhexylesters (CAS No. 68334-05-4) to aquatic organisms
from three different trophic levels are available. For all three trophic
levels (fish, aquatic invertebrates and algae) no toxicity within the
range of water solubility was observed.
Long-term tests evaluating the toxicity of Fatty acids, C18-unsatd.,
dimers, 2-ethylhexylesters to aquatic organisms are only available for
algae. The results of this test show no chronic effects within the range
of water solubility. Furthermore, the results of a study assessing the
chronic toxicity to fish of a structurally related substance show no
effects up to the limit of the water solubility.
There is no long-term test on aquatic invertebrates available for Fatty
acids, C18-unsatd., dimers, 2-ethylhexylesters (CAS No. 68334-05-4). The
chemical safety assessment according to Annex I of Regulation (EC) No
1907/2006 does not indicate the need to investigate further the
long-term toxicity to aquatic invertebrates. Thus, in accordance to
Annex IX, column 2 no further long-term toxicity test to aquatic
invertebrates is proposed. Available short-term studies for fish,
daphnia and algae, indicate no potential for aquatic toxicity (no
effects up to the limit of the water solubility). Moreover, the
long-term NOELR from the algal growth study and the NOEC of the fish
study performed with a structurally related substance are clearly above
the limit of water solubility (< 1 mg/L).
One GLP study conducted according to OECD guideline 209 over a period of
3 hours with activated sludge of a predominantly domestic sewage is
available for Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters. No
effects were observed under conditions tested up to limit of the water
solubility. Thus, the test substance has only a low toxicity for
activated sludge microorganisms and no inhibition of the degradation
activity of activated sludge in sewage treatment plants is anticipated.
No effects on aquatic organisms were observed in the available studies
for Fatty acids, C18-unsatd., dimers, 2-ethylhexylesters in any of the
three trophic levels (fish, daphnia, algae) up to the limit of water
solubility, neither in the short-term toxicity tests nor in long-term
tests with algae and fish. Furthermore, toxic effects on microorganisms
are not expected.
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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