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EC number: 947-849-1
CAS number: -
There is only limited data available for the aquatic toxicity of
the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15
alcohol (linear and branched), esters. Therefore, the aquatic toxicity
of the target substance was assessed by means of a read-across approach,
through which additional data from a structurally and chemically closely
related source substance was compiled in order to fulfill the standard
information requirements laid down in Annex XI of REACh Regulation (EC)
No 1907/2006. Read-across was performed in accordance with Regulation
(EC) No 1907/2006 Annex XI, 1.5.
According to Article 13 of Regulation (EC) No 1907/2006 "General
Requirements for Generation of Information on Intrinsic Properties of
substances", information on intrinsic properties of substances may be
generated by means other than tests e.g. from information from
structurally related substances (grouping or read-across), provided that
conditions set out in Annex XI are met. In Annex XI, "General rules for
adaptation of this standard testing regime set out in Annexes VII to X”,
it is stated that “substances whose physicochemical, toxicological and
ecotoxicological properties are likely to be similar or follow a regular
pattern as a result of structural similarity may be considered as a
group, or ‘category’ of substances. This avoids the need to test every
substance for every endpoint and avoids unnecessary animal testing”.
The target substanceFatty acids, C16, C18 and C18-unsaturated,
C12-15 alcohol (linear and branched), estersis a UVCB substance
consisting of four main constituents which are long-chain aliphatic
esters with fatty acid chain lengths ranging from 16 to 18 (unsaturated
and branched) and C12 – C15 alcohol components. In the present dossier,
the target substance will be assessed on the basis of aquatic toxicity
data compiled from the source substance Dodecyl oleate (CAS 36078-10-1).
The source substance was selected on the basis of structural
similarities and similarities in properties and/or activities to the
target substance, with due regard of the requirements for adequacy and
reliability of data. The source substance is a UVCB substance and is
characterized by similar fatty acid chain lengths (C18:1) and alcohol
components (C12) as the target substance. Therefore, the source
substance is considered a suitable representative for the assessment of
the aquatic toxicity of the target substance. Based on the high degree
of similarity between the structural and physico-chemical properties of
the target and source substance, it is assumed that the target substance
will exhibit a similar ecotoxicological profile as the selected source
substance. Where applicable, environmental and human health effects of
the target substance are predicted by interpolation or extrapolation
from source substance data in accordance with Annex XI, Item 1.5, of
Regulation (EC) No 1907/2006. A detailed read-across justification is
provided in IUCLID section 13.
By means of the read-across approach, guideline studies are
available for the short-term toxicity of the target substance to aquatic
algae and fish as well as for the long-term toxicity to aquatic
invertebrates and algae. All the available aquatic toxicity studies were
performed with the source substance Dodecyl oleate (CAS 36078-10-1) and
in compliance with GLP. Due to the extremely low water solubility of the
target substance (< 6.57 µg/L, OECD 105), long-term testing on aquatic
invertebrates was considered necessary to fully assess the potential
aquatic hazard. In addition, one experimental study is available for the
toxicity to microorganisms.
The study on the short-term toxicity to fish was conducted
according to OECD guideline 203. After 96 h of exposure of the model
organism Danio rerio to a Water Accommodated Fraction of the test item
(limit test), no mortality was observed and chemical analysis of the
test solution resulted in concentrations below the analytical detection
limit of 0.005 mg/L, reflecting the very low water solubility of the
test item. Thus, it was concluded that the test item does not cause
short-term toxic effects to fish up to the limit of water solubility.
The study on the long-term toxicity to aquatic invertebrates was
conducted according to OECD guideline 211. After 21 d of exposure of the
model organism Daphnia magna to five testing levels prepared as Water
Accommodated Fractions no effects on reproduction were observed and the
chemical analysis of test solutions resulted in concentrations below the
analytical detection limit of 0.005 mg/L reflecting the very low water
solubility of the test item. Thus, it was concluded that the test item
does not cause chronic effects to aquatic invertebrates up to the limit
of water solubility.
The study on the toxicity to aquatic algae was performed according
to OECD 201. After 72 h of exposure of the model organism Desmodesmus
subspicatus to five exposure levels prepared as Water Accommodated
Fractions, no effects on growth rate and yield were observed and the
measured test item concentrations in the test solutions were below the
limit of quantification (< 0.005 mg/L). Thus, it is concluded that the
test item does not cause toxic effects to aquatic algae up to the limit
of water solubility.
The study on the toxicity to activated sludge microorganisms was
conducted according to OECD 209.
After a 3 h incubation of the activated sludge with the test item,
no inhibition of the respiration rate was observed and it was concluded
that the test item does not cause toxicity to aquatic microorganisms.
In summary, the compiled data for short-term toxicity to two
trophic levels (fish and aquatic algae) and long-term toxicity to two
trophic levels (aquatic invertebrates and algae) neither indicate any
short-term nor long-term toxicity to aquatic organisms up to the limit
of water solubility. Furthermore, no inhibitory effects towards aquatic
microorganisms of activated sludge were recorded.
Due to the ready biodegradability (89.9% in 28 d, OECD 301 B) and
the high adsorption potential (log Koc > 5.0, KOCWIN v.2.00) of the
target substance, the substance is expected to be eliminated from sewage
treatment plants to a high extent. Release to the aquatic environment
and subsequent exposure of sediment is therefore very unlikely.
Furthermore, the substance is a long-chain aliphatic ester. Therefore,
in the unexpected event where absorption of the substance by aquatic
organisms should occur, it is expected to be rapidly metabolized via
enzymatic hydrolysis into its corresponding fatty acids and fatty
alcohols, which are known from literature to metabolize well in aquatic
organisms. Against this background, the overall potential for chronic
exposure and for bioaccumulation in aquatic organisms is judged to be
Therefore, it can be concluded that the target substance Fatty
acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and
branched), esters presumably does not cause short-term or long-term
toxicity to aquatic organisms up to the limit of water solubility (<
6.57 µg/L at 20 °C, pH 6.3, OECD 105) and is not expected to affect the
degradation process in commercial sewage treatment plants.
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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