Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 297-443-7 | CAS number: 93572-14-6
- 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
Data investigating the aquatic toxicity of Fatty acids, soya,
2-ethylhexyl esters (CAS 93572-14-6) are not available. In order to
fulfil the standard information requirements set out in Annex VII, 8.5,
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).
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 state
that 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 and source substances show structural similarities
and are characterised by similar physio-chemical properties. The target
substance and source substances are monoesters of primary and secondary
(isopropanol) alcohols C2-C8 and fatty acids (saturated and unsaturated)
with the chain length C8-C18. A detailed analogue approach justification
is provided in the technical dossier (see IUCLID Section 13).
Experimental data for the target substance Fatty acids, soya,
2-ethylhexyl esters (CAS 93572-14-6) are not available. Therefore, the
source substances Fatty acids, C8-16, 2-ethylhexyl esters (CAS
135800-37-2) and 2-ethylhexyl oleate (CAS 26399-02-0) and Fatty acids,
C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS 85049-37-2) were
selected to cover the aquatic toxicity endpoints.
In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping
and read-across, the target substance and all source substances are not
considered to be harmful to aquatic organisms based on the results from
short-term studies with fish, aquatic invertebrates and aquatic algae.
Moreover, long-term studies with aquatic invertebrates did not result in
any long-term effects on reproduction. The available short-term toxicity
studies (fish, Daphnia, algae) did not demonstrate any toxicity of the
analogue substances to aquatic organisms up to the limit of water
solubility.
The assessment of the acute toxicity of the target substance Fatty
acids, soya, 2-ethylhexyl esters (CAS 93572-14-6) to fish is based on a
read across the structurally most similar analogue source substances
Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS
85049-37-2) and Fatty acids, C8-16, 2-ethylhexyl esters (CAS
135800-37-2). Mortality or symptoms of intoxication of fish were not
observed and thus a LC50 (96h) > 10000 mg/L based on the nominal
substance concentration was reported in both read across studies.
The assessment of the acute toxicity of Fatty acids, soya, 2-ethylhexyl
esters (CAS 93572-14-6) to aquatic invertebrates is therefore based on a
read across the structurally analogue source substances 2-ethylhexyl
oleate (CAS 26399-02-0) and Fatty acids, C8-16, 2-ethylhexyl esters (CAS
135800-37-2). Both studies determined no effect up to the limit of water
solubility of the test substances and an EC50 (48h) > 100 mg/L was
reported.
Short-term toxicity to aquatic algae: The assessment of the acute
toxicity of Fatty acids, soya, 2-ethylhexyl esters (CAS 93572-14-6) is
based on a read across the structurally similar analogue source
substances 2-ethylhexyl oleate (CAS 26399-02-0) and Fatty acids, C8-16,
2-ethylhexyl esters (CAS 135800-37-2) . Both studies were conducted with
Scenedesmus subspicatus and reported no toxicological effects on aquatic
algae up to the limit of water solubility of the substances and an
ErC50(72 h) of > 100 mg/L was determined.
Data on the long-term toxicity to fish are not available for any of the
analogue substances. However, short-term studies available for fish,
daphnia and algae, all indicate a low potential for aquatic toxicity.
Moreover, the reliable NOECs obtained from twoa daphnia reproduction
studies are above the limit of water solubility. Additionally, the
aquatic concentrations of the target and source substances are expected
to be very low. This assumption is based primarily on the lack of water
solubility, the ready biodegradability and high adsorption potential
(log Koc > 3, MCI method, KOCWIN v2.00). The substances are thus
expected to be eliminated in sewage treatment plants to a high extent.
In the aquatic environment, the concentration in the water phase will be
reduced by biodegradation and adsorption to solid particles and to
sediment. If exposure would occur, food ingestion is likely to be the
main uptake route of the analogue substances in fish, since the
substances will be adsorbed to solid particles potentially ingested by
fish. In the case of ingestion, the analogue substances are predicted to
undergo metabolism. Studies on rats demonstrated that esters of primary
alcohols, containing from 1 to 18 carbon atoms, with fatty acids,
containing from 2 to 18 carbon atoms, are hydrolysed by pancreatic
lipases. Measured rates of enzyme catalysed hydrolysis varied between 2
and 5 µeq/min/mg enzyme for the different chain lengths (Mattson and
Volpenhein, 1972; and references therein). The esters are thus expected
to be hydrolysed by lipases. The resulting free fatty acids and alcohols
are absorbed from the intestine into the blood stream. The alcohols are
metabolised primarily in the liver through a series of oxidative steps,
finally yielding carbon dioxide (Berg et al., 2001; HSDB). Fatty acids
are either metabolised via the beta-oxidation pathway in order to
generate energy for the cell or reconstituted into glyceride esters and
stored in the fat depots in the body (Berg et al., 2001). Metabolic
pathways in fish are generally similar to those in mammals. Lipids and
their constituents, fatty acids, are in particularly a major organic
constituent of fish and play major roles as sources of metabolic energy
(Tocher, 2003).
In conclusion, the analogue substances will be mainly taken up by
ingestion and digested through common metabolic pathways, providing a
valuable energy source for the organism, as dietary fats. Long-term
toxic effects on fish are therefore not to be expected.
The assessment of long-term toxicity of Fatty acids, soya, 2-ethylhexyl
esters (CAS 93572-14-6) to aquatic invertebrates is based on a study
conducted with the analogue substances 2-ethylhexyl oleate (CAS
26399-02-0) and Fatty acids, C8-16, 2-ethylhexyl esters (CAS
135800-37-2). The studies reported no effect of the test substances on
the reproduction or mortality of the test organisms. Therefore, a
NOEC(21 d) > 1 mg/L (nominal) based on reproduction was determined in
both studies.
The assessment of the toxicity of Fatty acids, soya, 2-ethylhexyl esters
(CAS 93572-14-6) is based on a read across to the analogue substance
Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS
85049-37-2). The test substance did not affect the respiration rate and
thus an EC50(3h) value of >100 mg/L was determined.
Overall, it can be concluded that the target substance Fatty acids,
soya, 2-ethylhexyl esters (CAS 93572-14-6) is not toxic to aquatic
organisms up to the limit of water solubility, based on the results from
a suitable source substance.
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.