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EC number: 306-232-1
CAS number: 96690-38-9
A study according to OECD 211 for a similar read-across substance was technically not feasible due to substance characteristics.
Since no studies investigating the long-term toxicity to aquatic
invertebrates of Fatty acids, C16-18, 2-octyldodecyl esters (CAS
96690-38-9) are available for this endpoint, in accordance to Regulation
(EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally
related category member 2-octyldodecyl isooctadecanoate (CAS 93803-87-3)
was conducted. The read-across substance is characterized by the same
alcohol component (2-octyldodecan-1-ol) and a very similar fatty acid
(C16-18 compared to C18iso (target)). This read-across is justified in
detail in the overall summary (IUCLID Section 6.1) and within the
category justification in IUCLID Section 13. In this case of
read-across, the best suited (highest degree of structural similarity,
nearest physico-chemical properties) read-across substances were used
for the assessment. Nevertheless, as it can be seen in the data matrix
of the category justification in section 13 and the overall summary, all
reliable data in the category support the hazard assessment of each
category member by showing a consistent pattern of results.
A statement from a laboratory is available indicating that the
study with the read-across substance 2-octyldodecyl isooctadecanoate is
technically not feasible due to substance characteristics (Bogers,
1998).Acute testing inDaphnia magnawas performed by exposing organisms
to Water Accommodated Fractions (WAFs) (see NOTOX Project 227341 ‘Acute
toxicity study inDaphnia magnawith [trade name]‘). However, it is not
common practice to use this approach in a prolonged toxicity test. The
use of a column generator with the test substance coated on an inert
carrier (glass beads or celite) is not possible as the test substance is
a liquid. The testing in a flow-through system is also no possible
alternative, since the hydrophobic character of the test substance
hampers any way of mixing with the dilution water. Based on the high
hydrophobicity, there is no analytical method sensitive enough to detect
concentrations of the test substance in water samples. As a result, it
is not possible to give any analytical support to the reproduction test
with Daphnia magna. This analytical support is essential to meet the
acceptability criterion for evidence that the actual concentration had
been maintained within a 20% window during the total test period.
Owing to the fact that the test substance is a liquid with a water
solubility below detection (< 0.05 mg/L) and a log Kow of > 7, it is not
possible to prepare solutions that can be tested in a 21-day
reproduction test withDaphnia magna. Further, these characteristics
support the expectation that it will not be very likely that
bioavailable concentrations of the test substance will ever occur in the
water phase, i.e. concentrations high enough to induce any acute or
chronic effects in aquatic organisms.Based on the available result from
one structurally related read-across substance (in accordance to
Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a
similar ecotoxicological profile and comparable structure, it can be
concluded that the same result is expected when testing Fatty acids,
C16-18, 2-octyldodecyl esters.
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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