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Diss Factsheets
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EC number: 286-061-6 | CAS number: 85186-76-1
- 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
Acute Toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read Across Category Endpoint Specific Report
Data source
Materials and methods
- Test type:
- standard acute method
Test material
- Test material form:
- liquid
Constituent 1
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Table 1: Results from key studies on source chemicals of the category for acute oral toxicity tests
ID# |
CAS |
Acute oralToxicity |
Fatty acids, C8-16, 2- |
135800-37-2 |
Experimental result: |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
Experimental result: |
2-Ethylhexyl palmitate |
29806-73-3 |
No data |
Fatty acids, C16-18 and C18-unsatd., 2- |
85049-37-2 |
Experimental result: LD50 > |
Fatty acids, C16-18, 2-ethylhexyl esters |
91031-48-0 |
LD50 > 4300 mg/kgbw |
2-Ethylhexyloleate |
26399-02-0 |
Experimental result: |
2-Ethylhexylstearate |
22047-49-0 |
Experimental result: |
Similar toxicokinetic behavior and toxicity profile
All category members are subject to enzymatic hydrolysis by pancreatic lipases resulting in free acids and alcohol. Based on current literature, when absorbed from intestines and carried through blood stream, fatty acids are oxidized by beta-oxydation pathway in order to provide energy for cell and stored as glycerides esters in fat deposit. The alcohols are primarily metabolized in the liver.
Hence, it can be stated that the members of the category have the same toxicity due to the same metabolic pathways when absorbed in the organisms.
Several studies were performed in members of the category for acute oral toxicity. For acute oral toxicity studies, results showed an LD50 value greater than 2000 mg/kgbw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results from experimental study performed on the substances of the LCAE Category, the LD50 value for the Isostearate Ethyl Hexyl was defined higher than 2000 mg/kg bw. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Acute Oral Hazard (or Category 5 according to GHS criteria).
- Executive summary:
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category for Long Chain Fatty Acid was performed in order to provide informations on the Isostearate Ethyl Hexyl.
This category was based on common and shared physico-chemical and structural properties as:
- common functional group,
- common precursors and the likehood of common impurities as well as common breakdown products via biological processes, which are chemically structurally similar, and
- constant pattern in the changing of the potency of the properties across the category.
The fatty acids linked with 2-ethylhexyl esters have a common metabolic fate in organisms as glycolytic and fatty acid pathways after first hydrolysis step which led in breakdown products. The common toxicokinetic properties and behavior are expected due to the constant pattern (ethylhexyl esters and the fatty acid chain). The toxicological profiles between the members of the category are expected to be the same.
Several reliable studies were available (GLP, accordingly to OECD 401 guideline method). The experimental studies were performed in rodents (rat and mouse) which were treated orally (gavage) by single dose. Lethal Dose 50 (LD50 ) values were found to be greater than 2000 mg/kg bw, or 4300 mg/kg bw and 10 0000 mg/kg bw in the differents test performed.
According to the results from experimental study performed on the substances of the LCAE Category, the LD50 value for the Isostearate Ethyl Hexyl was defined higher than 2000 mg/kg bw. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Acute Oral Hazard (or Category 5 according to GHS criteria).
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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