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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
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Genetic toxicity: in vitro
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Materials and methods
Test material
- Test material form:
- liquid
Constituent 1
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, 1537, 102, 100, 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results from key studies on source chemicals of the category for in vitro mutagenicity tests.
ID# |
CAS |
In vitro gene mutation study in bacteria (Ames test) |
Fatty acids, C8-16, 2- |
135800-37-2 |
Experimental result: |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
No data |
2-Ethylhexyl palmitate |
29806-73-3 |
No data |
Fatty acids, C16-18 and C18-unsatd., 2- |
85049-37-2 |
No data |
Fatty acids, C16-18, 2-ethylhexyl esters |
91031-48-0 |
Experimental result: Negative |
2-Ethylhexyl oleate |
26399-02-0 |
No data |
2-Ethyl hexyl stearate |
22047-49-0 |
No data |
Similar toxicokinetic behavior and toxicity profile
None of the tested source substances of the category were positive to Ames test (OECD TG 471). They were not mutagenic for bacteria strains.
Based on the structural similarities between source and target chemicals and their common toxicokinetic behavior, the target substance was considered as not mutagenic in in vitro system.
Applicant's summary and conclusion
- Conclusions:
- Based on the available datas for in vitro bacteria reverse mutation of the members of the category substances, nogenotoxicity was observed for both the tested substances. Hence, the registered substance 2-ethylhexyl isostearate could be considered as not mutagenic for bacteria strain using this category approach and according to the CLP 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 studies were performed on substances Fatty acids, C16-18, 2-ethylhexyl esters, 2-ethylhexyl oleate and Fatty acids, C8-16, 2-ethylhexyl ester in order to investigate the mutagenicity potential properties in bacteria. None of these experimental studies showed positive effect. Hence, the members of the category can be considered to have no mutagenic effects on bacteria strain.
Based on the structural similarities betweensource and target chemicals and their common toxicokinetic behavior, the target substance was considered as not mutagenic ini n vitro system using bacterias strain.
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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