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Diss Factsheets
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EC number: 946-968-6 | CAS number: -
- 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
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 15 - August 7, 2018
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP compliance certification included in full study report
Test material
- Reference substance name:
- [ω-hydroxy-C16 (saturated and unsaturated) and C16 (unsaturated)] fatty acids
- EC Number:
- 946-968-6
- IUPAC Name:
- [ω-hydroxy-C16 (saturated and unsaturated) and C16 (unsaturated)] fatty acids
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Identification: [ω-hydroxy-C16 (saturated and unsaturated) and C16 (unsaturated)] fatty acids
Appearance: Brown semi-solid gel (at 20°C)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm™ tissues, Lot No. 28368 Kit D, were received from MatTek Corporation (Ashland, MA) on 22 May 2018 and refrigerated at 2-8°C. Before use, tissues were incubated (37±1°C, 5±1% CO2) with assay medium (MatTek) for a one-hour equilibration. Equilibration medium was replaced with fresh medium before dosing.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μl of the test article were applied to the top of each EpiDerm™ tissue. Nylon mesh was then placed on top to facilitate even distribution of the test article.
- Duration of treatment / exposure:
- The test article remained in contact with the EpiDerm™ tissue for 3 minutes at room temperature and 60 minutes at 37±1°C, 5±1% CO2.
- Duration of post-treatment incubation (if applicable):
- At the end of the exposure period, each EpiDerm™ tissue was rinsed with phosphate buffered saline (PBS) and transferred to a 24-well microplate containing 300 μl of MTT solution (1 mg/ml MTT in DMEM). The tissues were then returned to the incubator for a three-hour MTT incubation period. Following the MTT incubation period, each EpiDerm™ tissue was rinsed with PBS and then treated overnight at room temperature with 2.0 ml of extractant solution (isopropanol) per well.
- Number of replicates:
- Each treatment with test article or control was conducted in duplicate.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 92.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% mean tissue viability
- Positive controls validity:
- valid
- Remarks:
- 2% mean tissue viability
- Remarks on result:
- other: no indication of corrosion
- Other effects / acceptance of results:
- Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 0.7% to 8.8%. Viability differences between the two identically treated tissues at 60 minutes were 0.1% to 2.3%. Inter-tissue viability differences at both time points met the acceptance criterion (≤30%).
Any other information on results incl. tables
The summarized results and corrosion classifications are as follows:
Test and Control Article Identity |
Mean Tissue Viability (3 min.) |
Mean Tissue Viability (3 min.) |
Predicted Corrosivity |
[ω-hydroxy-C16 (saturated and unsaturated) and C16 (unsaturated)] fatty acids |
105.5% |
92.6% |
Not corrosive |
Tissue culture water (Negative Control) |
100.0% |
100.0% |
Not corrosive |
8.0N Potassium hydroxide solution (Positive Control) |
24.0% |
2.0% |
Corrosive |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vitro skin corrosion test was conducted according to OECD 431 guideline and GLP principles. It is concluded that this test is valid and that the test substance is not corrosive in the in vitro skin corrosion test.
- Executive summary:
In an in vitro skin corrosion test using a human skin model (MatTek EpiDerm™ human epidermis) performed according to OECD 431 guideline and GLP principles, the influence of the test substance on the viability of human skin was tested. The test substance was applied directly to cultured tissue (50 μL/ tissue, n=2). After 3-minute and 60-minute treatments the substance was removed and the viability of the cells was tested by reduction of MTT. The realtive mean tissue viability obtained after 3-minute and 1-hour treatments with the test substance was 105.5% and 92.6%, respectively. The positive control had a mean cell viability of 2.0% after 1 -hour exposure.
Since the mean relative tissue viability was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment, it is concluded that the test substance is not corrosive in the in vitro skin corrosion test.
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