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EC number: 286-283-3 | CAS number: 85203-92-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- 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 and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Additional information
There are no data available investigating the aquatic toxicity of Octadecanoic acid, C16-20-branched alkyl esters (CAS 85203-92-5). In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
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 aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (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.
The target substance is characterized as an ester of linear fatty acids and linear alcohols with different compositions of C16-C20 fatty acids and C16-C18 fatty alcohols (C18 fatty acid, C16 alcohol; C16 fatty acid, C18 alcohol; C18 fatty acid, C18 alcohol; C20 fatty acid, C16 alcohol). The source substances are structurally very similar to the target substance. The source substance 2-octyldodecyl isooctanoate (CAS 93803-87-3) is and ester of isooctanoate (C18 iso) and 2-octyldodecanol (C20 branched). Lauryl Oleate (CAS 36078-10-1) is specified as an ester of C18 unsaturated fatty acid and C12 fatty alcohol whereas the source substance 9-Octadecenoic acid (Z)-, 9-octadecenyl ester, (Z)- (CAS 3687-45-4) is an ester of C18 unsaturated fatty acid and C18 unsaturated alcohol.
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
All available experimental studies on the source substances,
performed according to internationally accepted guidelines, indicate no
evidence of acute and chronic toxicity to aquatic organisms up to the
limit of water solubility. The water solubility of the target substance
was determined to be <10 µg/L at 20 °C, pH=6.3.
No
inhibition of reproduction of Daphnia magna and no inhibition of growth
of aquatic algae were observed in experimental studies according to OECD
guidelines up to the limit of water solubility. Due to the low water
solubility, long-term testing to aquatic invertebrates was considered to
be more relevant compared to short-term testing in order to assess the
aquatic toxicity. The available studies performed with suitable source
substances resulted in a NOELR (21 d) ≥ 100 mg/L indicating no effects
on reproduction up to the limit of water solubility. Moreover, an expert
statement from a laboratory is available indicating that a chronic
toxicity study with Daphnia magna is technically not feasible due to
substance characteristics. 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 source
substance is a liquid with water solubility below detection limit (<
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 with Daphnia 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 results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Octadecanoic acid, C16-20-branched alkyl esters (CAS 85203-92-5) exhibits no toxic effects on freshwater organisms up to the limit of the water solubility. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the target and the source substances support the read-across by showing a consistent pattern of results.
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.
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