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EC number: 288-309-9 | CAS number: 85711-49-5
- 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
- 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
Test material
- Reference substance name:
- Fatty acids, coco, esters with oxybis(propanediol)
- EC Number:
- 288-309-9
- EC Name:
- Fatty acids, coco, esters with oxybis(propanediol)
- Cas Number:
- 85711-49-5
- Molecular formula:
- Not possible for UVCB
- IUPAC Name:
- Fatty acids, coco, esters with oxybis(propanediol)
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
- Description of the cell system used: After receipt of the SkinEthicTM HCE kit, all of the corneal epithelium units used in the study were pre-incubated in maintenance medium (provided by kit supplier) at 37 ± 2°C, 5 ± 1 % CO2, ≥ 90% humidity for at least overnight before dosing. Before application, the 2 corneal epithelium units for test substance, negative control substance and positive control substance were transferred to fresh pre-warmed maintenance medium, respectively. The application was conducted by gently spreading each substance on the epithelium without touching it to ensure the substance cover all the tissue surface, 2 units per substance. A nylon mesh was used if the test substance was sticky or viscous. The incubation was made at 37 ± 2°C, 5 ± 1 % CO2, ≥ 90% humidity for 30 ± 2 minutes.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 10 ± 1 µl 0.01M PBS pH = 7.4 and 30 ± 2 µl test item
- Duration of treatment / exposure:
- 30 ± 2 min
- Duration of post- treatment incubation (in vitro):
- After treatment, each treated corneal epithelium unit was rinsed with 20 ml sterile 0.01M PBS pH 7.4 (approximately 10 ml per push) to remove the residue of test chemicals from the epithelium surface. After rinsing, remaining PBS was removed by energized reversal; a cotton-swabs was used to sweep the surface carefully when necessary. The rinsed unit was transferred to 750 µl fresh pre-warmed maintenance medium. The unit was then immerged with another 750 µl fresh pre-warmed maintenance medium by applying the medium topically on the tissue. The incubation was made at 37 ± 2 °C, 5 ± 1 % CO2, ≥ 90% humidity for 30 ± 2 minutes. At the end of incubation, each unit was removed from the maintenance medium. The medium was decanted off by turning over the insert. The bottom of the insert was dried carefully by gently taping on a dry absorbent paper and cotton swab. Each corneal epithelium unit was then transferred into 300 µl MTT solution (1 mg/ml in maintenance medium protected from light) and incubated at 37 ± 2 °C, 5 ± 1 % CO2, ≥ 90% humidity for 3 hours ± 15 minutes.
After incubation, each unit was rinsed in 300 µl PBS to remove excess MTT solution or maintenance medium and then dried on absorbent paper. The unit was then transferred to a new plate with 750 µl isopropanol per well, another 750 µl isopropanol was added topically onto each tissue insert. The plate was sealed and stored in fridge overnight protected from light. After the incubation period, the plate was shaken at least for 30 minutes (~120 rpm) at room temperature to ensure the plate recover at room temperature.
The inserts were perforated using a tip on a micropipette. The extraction solution was homogenized vigorously until a homogenous solution was generated. The empty inserts were removed. Two 200 µl of solution from each well was transferred into a 96-well plate. The absorbance (OD) at 570 nm was read using microplate reader. Isopropanol was used as blank. - Number of animals or in vitro replicates:
- 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: viability (%)
- Run / experiment:
- mean
- Value:
- 90.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the SkinEthicTM HCE EIT (for the liquid’s protocol) Validated Reference Method (VRM) and associated with UN GHS classification system, the test item - Fatty acids, coco, esters with oxybis(propanediol), Lot No: 80118 is considered No Category.
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