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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
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 Target Substance Endpoint Record
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Test material
- Test material form:
- liquid
Constituent 1
Results and discussion
In vivo
Results
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1: Results from key studies on source chemicals of the category for skin irritation and corrosion tests
ID# |
CAS |
Skin irritation or skin corrosion |
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 |
Experimental result: Not irritating |
Fatty acids, C16-18 and C18-unsatd., 2- |
85049-37-2 |
No data |
Fatty acids, C16-18, 2-ethylhexyl esters |
91031-48-0 |
No data |
2-Ethylhexyloleate |
26399-02-0 |
Experimental result: |
2-Ethylhexylstearate |
22047-49-0 |
Experimental result: |
According to the current literature, esterase enzymes were present into the skin of different mammalian species (as human, rodents or minpigs). These enzymes, as carboxylesterase, hydrolyzed different substrates as xenobiotic or different ester as fatty acids esters (C. Jewell, 2007; J.J. Prusakiewicz, 2006). Based on this principle, when applied on skin, the source and the target substances are expected to be substrates of these carboxylesterase. They are hydrolyzed into fatty acids and alcohols. In the case that the products of hydrolysis could across the dermal barrier to reach systemic system, they have the same behavior as oral ingestion. The potential toxicity should be bring by these hydrolyzed products.
According to their very low solubility in water and their log Kow values, these substances are not expected to be strong acid or basic substances. However, based on the probable pH values of these substances, acid reserve value is necessary to assess potential irritation/corrosion effect (Young J.R and M.J. How, 1994). Despite no acid reserve value, and regarding the potential nonacid or basic pH of these substances, no local adverse effect, as irritation or corrosion, is expected in skin for the target substance..
Based on the available key studies, the members of the category were considered as not irritating when applied on skin. Hence, the target substance was not classified for skin irritation according to CLP criteria and the category approach.
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 category substances did not led to irritation when applied on rabbit skin. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Skin Irritation.
- 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 to assess skin irritation for members of the category. They are considered as reliable (GLP compliant, method equivalent or similar to OECD 404 guideline method). Rabbits were used for these experimental studies. Shaved or clipped skin were treated under semi occlusive condition for 72 hours and observations were performed at differents timepoints (24, 48 and 72 hours) according to Draize scheme. No reaction or slight reaction was observed (recovery within 24 hours).
According to the results from experimental study performed on the substances of the LCAE Category, the category substances did not led to irritation when applied on rabbit skin. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Skin Irritation.
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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