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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: 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)
- Rationale for reliability incl. deficiencies:
- guideline study
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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP cokpliance certificate 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
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- EpiOcular™ tissues, Lot No. 27430 Kit E, were received from MatTek on 22 May 2018 and refrigerated at 2-8°C. Before use, the 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 for an additional overnight equilibration of 16 to 24 hours. After the overnight incubation, the tissues were moistened with 20 μl of phosphate-buffered saline (PBS) and incubated at 37±1°C, 5±1% CO2 for 30±2 minutes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 μl of the test article were applied to duplicate EpiOcular™ tissues. Each treatment with test article or control was conducted in duplicate.
- Duration of treatment / exposure:
- The tissues were incubated at 37±1°C, 5±1% CO2 for 30±2 minutes.
- Duration of post- treatment incubation (in vitro):
- After dosing and incubation, the tissues were rinsed with phosphate-buffered saline (PBS) and soaked in 5 ml of room-temperature assay medium in a 12-well plate for 12 minutes. The soaked tissues were then incubated in fresh assay medium at 37±1°C, 5±1% CO2 for 120 minutes. At the end of the incubation period, each EpiOcular™ tissue was transferred to a 24-well plate containing 300 μl of MTT solution (1 mg/ml MTT in Dulbecco's Modified Eagle's Medium). The tissues were then returned to the incubator for a three-hour MTT incubation period. Following the MTT incubation period, each EpiOcular™ tissue was rinsed with PBS, and then treated with 2.0 ml of extractant solution (isopropanol) overnight at room temperature.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Tissue viability
- Run / experiment:
- Mean tissue viability of two treated tissues.
- Value:
- 45.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- The test item is determined to be an irritant based on a mean tissue viability less than or equal to 60% according to the OECD Test Guideline No. 492, “Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage”.
- Other effects / acceptance of results:
- The mean OD570 of the negative control tissues was 2.022, which met the acceptance criteria of greater than 0.8 and less than 2.5. The mean relative viability of the positive control tissues was 35.3%, which met the acceptance criterion of less than 50%. The differences in viability between identically treated tissues were 0.21% to 8.33%, which met the acceptance criterion of less than 20%. All controls passed the acceptance criteria for a valid study.
Any other information on results incl. tables
The summarized results and irritation classifications are as follows:
Test and Control Article Identity |
Mean Tissue Viability |
Tissue Viability Std. Deviation |
Irritancy Classification |
GHS Calssification |
[ω-hydroxy-C16 (saturated and unsaturated) and C16 (unsaturated)] fatty acids | 45.8% | 8.3% | Irritant | Eye Irritation Category 1 or 2 |
Tissue culture water (Negative Control) | 100% | 0.2% | Non-Irritant | Not classified |
Methyl acetate (Positive Control) | 35.3% | 1.3% | Irritant | Eye Irritation Category 1 or 2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the outcome of a Reconstructed Human Cornea-like Epithelium (RhCE) Test Method performed according to OECD 492 guideline and GLP principles, it is concluded that the substance is irritanting to the eye.
- Executive summary:
A Reconstructed Human Cornea-like Epithelium (RhCE) Test Method was performed with the substance according to OECD guideline 492 and GLP principles. The substance was applied undiluted (50 μL/ tissue, n=2). The mean in vitro tissue viability of the positive control was 35.3%, and the mean in vitro tissue viability of the negative control (tissue culture water) was 100%. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The mean viability of tissue exposued to the test substance was 45.8%. Since the mean tissue viability of the treated tissues was ≤60%, the substance is considered an eye irritant and should be classified as either Category 1 or 2 according to Regulation (EC) No 1272/2008.
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