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EC number: 246-625-4 | CAS number: 25111-05-1
- 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 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1). 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 available information on the source substances is used to
predict the same endpoints for 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl
dioleate (CAS 25111-05-1). The target substance is characterized by C18
unsaturated fatty acid esterified trimethylolpropane (TMP) (mainly di-
and triester). The selected source substances are structurally very
similar to the target substance and are thus adequate for the assessment
of aquatic toxicity. Fatty acids, C16-18 even numbered and C18-unsatd.
triesters with propylidynetrimethanol (former CAS 57675-44-2) is
characterized by C18, C18 unsatd fatty acids triesterified with TMP.
Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd.,
triesters with trimethylolpropane (former CAS 85186-89-6) mainly
consists of C18:1 FA triesterified with TMP. The third source substance
Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and
linear, di- and triesters with trimethylolpropane (former CAS
85005-23-8) is characterized as a triester of TMP and C16-C18 and C18
unsatd. branched and linear fatty acids. The fourth source substance
Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane
(CAS 68002-78-8) is characterized by C18 unsatd fatty acids
triesterified with TMP.
A detailed analogue approach justification is provided in the technical
dossier (see IUCLID Section 13).
All available experimental data on the source substances performed
according to internationally accepted guidelines indicate no evidence of
acute and chronic toxicity to aquatic organisms. Data for all three
trophic levels are available. No toxicity was observed up to the limit
of water solubility in all available experimental studies. The water
solubility of the target substance was determined to be 1.26 µg/L -
13.54 µg/L at 20 °C, pH=6.3 (OECD 105), mean: 7.40 µg/L.
The short-term toxicity to fish was determined in standard OECD guideline studies with freshwater and marine fish (from the source substances Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2), Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) and Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8)). No mortality was observed after 96 h up to the limit of water solubility. The same was recorded for the short-term toxicity to aquatic invertebrates and to aquatic algae. No immobilization 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 (from the source substances Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2) and Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6).
Due to the low water solubility, long-term testing with aquatic invertebrates was considered to be necessary to assess the aquatic toxicity. The available study performed with the suitable source substance Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane (CAS 68002-78-8) resulted in a NOELR (21 d) ≥ 0.11 g/L indicating no effects on reproduction up to the limit of water solubility.
Long-term toxicity testing to fish was not considered to be necessary since there was no evidence from the available data that fish are more sensitive compared to aquatic invertebrates. No toxicity to fish was observed in the available acute tests. Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.
The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. The experimental studies with the source substances Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2, Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) and Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) did not indicate inhibition of respiration of activated sludge microorganisms.
Based on the result from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate 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 suitable 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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