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EC number: 941-810-2 | 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:
- 2022-03-04 to 2022-03-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
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)
- Version / remarks:
- Adopted June 18, 2019
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sophorolipids: fermentation products of glucose and fatty acids, C18 (unsaturated), glycerol esters with yeast Candida Bombicola
- EC Number:
- 941-810-2
- IUPAC Name:
- Sophorolipids: fermentation products of glucose and fatty acids, C18 (unsaturated), glycerol esters with yeast Candida Bombicola
- Test material form:
- solid
- Details on test material:
- 59.0% dry matter
Constituent 1
Test animals / tissue source
- Species:
- other: Reconstructed Human Cornea-like Epithelium (RhCE)
- Details on test animals or tissues and environmental conditions:
- The EpiOcular tissue construct is a nonkeratinized epithelium prepared from normal human keratinocytes. It models the cornea epithelium with progressively stratified, but not cornified cells. A cell suspension is seeded into the insert in specialized medium. After an initial period of submerged culture, the medium is removed from the top of the tissue so that the epithelial surface is in direct contact with the air. This allows the test material to be directly applied to the epithelial surface in a fashion similar to how the corneal epithelium would be exposed in vivo.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
The viscous liquid test material was applied undiluted (50 µL) directly on top of the tissue. - Duration of treatment / exposure:
- 30 minutes
- Observation period (in vivo):
- 120 minutes
- Number of animals or in vitro replicates:
- The test was performed on a total of 2 tissues per test material together with a negative control and positive control. Two tissues were treated with 50 µL Milli-Q water (negative control) and 2 tissues with 50 µL Methyl Acetate (positive control) respectively.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
After an initial period of submerged culture, the medium is removed from the top of the tissue so that the epithelial surface is in direct contact with the air. This allows the test material to be directly applied to the epithelial surface in a fashion similar to how the corneal epithelium would be exposed in vivo.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- mean of 2 replicates
- Value:
- ca. 11
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Difference between two tissues (percentage): 3.4. Acceptability criteria fulfilled.
- Irritation parameter:
- mean percent tissue viability
- Run / experiment:
- mean of 2 replicates
- Value:
- ca. 21
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Difference between two tissues (percentage): 29. Since the difference was above the maximum of 20%, the experiment was repeated.
- Other effects / acceptance of results:
- OTHER EFFECTS:
- non
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for solvent control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Interference of the Test Material with the MTT Endpoint:
The test material was checked for possible direct MTT reduction by adding the test material to MTT medium. Because no color changes were observed it was concluded that the test material did not interact with the MTT endpoint.
The test material was checked for color interference in aqueous conditions. Addition of the test material to Milli-Q and isopropanol resulted after subtraction of the blank in an OD of
-0.0002 and 0.0049, respectively. Therefore it was concluded that the test material did not induce color interference.
Main Assay:
The mean absorption at 570 nm measured after treatment with the test material and controls are presented in Table 1.
The individual OD570 measurements are presented in Table 3.
Table 2 shows the mean tissue viability obtained after 30 ± 2 minutes treatment with the test material compared to the negative control tissues. Eye hazard potential is expressed as the remaining cell viability after exposure to the test material. The relative mean tissue viability obtained after 30 ± 2 minutes treatment with the test material compared to the negative control tissues was 21%. The difference between the percentage of viability of two tissues treated with the test material was 29%. Since the difference was above the maximum of 20%, the experiment was repeated.
In the repeat experiment, the relative mean tissue viability obtained after 30 ± 2 minutes treatment with the test material compared to the negative control tissues was 11%. The difference between the percentage of viability of two tissues treated identically was 9.2%, indicating that the test system functioned properly.
The positive control had a mean cell viability of 20% and 37% after 30 ± 2 minutes exposure, in the initial and repeat experiment, respectively. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range (See Table 4).
Since the mean relative tissue viability for the test material in both experiments was below 60% after 30 ± 2 minutes treatment it is considered to be potentially irritant or corrosive to the eye.
Mean Absorption in the EpiOcular™ Test with PC-2021-999
First experiment
| A (OD570) | B (OD570) | Mean (OD570) |
| SD |
Negative control | 1.204 | 1.121 | 1.163 | ± | 0.058 |
Test material | 0.080 | 0.418 | 0.249 | ± | 0.239 |
Positive control | 0.244 | 0.228 | 0.236 | ± | 0.011 |
OD = optical density
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.041). Isopropanol was used to measure the background absorption.
Second experiment
| A (OD570) | B (OD570) | Mean (OD570) |
| SD |
Negative control | 1.754 | 1.923 | 1.838 | ± | 0.119 |
Test material | 0.237 | 0.175 | 0.206 | ± | 0.044 |
Positive control | 0.729 | 0.616 | 0.672 | ± | 0.080 |
OD = optical density
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.041). Isopropanol was used to measure the background absorption.
Mean Tissue Viability in the EpiOcular™ Test with PC-2021-999
First experiment
| Mean tissue viability (percentage of control) | Difference between two tissues |
Negative control | 100 | 7.1 |
Test material | 21 | 29 |
Positive control | 20 | 1.4 |
Second experiment
| Mean tissue viability (percentage of control) | Difference between two tissues |
Negative control | 100 | 9.2 |
Test material | 11 | 3.4 |
Positive control | 37 | 6.2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Expert judgement: not Category 1
- Conclusions:
- In conclusion, the test material is identified as no prediction can be made regarding the classification in the EpiOcular™ test under the experimental conditions described in this report.
- Executive summary:
In an in vitro eye irritation guideline study (EpiOcular™ Cornea Epithelial Model) according to OECD 492 under GLP conditions, undiluted “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola” was applied to the models for 30 min at 37 °C. The test was performed in duplicates.
Physiological saline was used as negative control, Methyl Acetate as positive control. Both controls confirmed the validity of the study.
In this study, the mean tissue viability was 21% in the first experiment, and 11% in the second experiment. According to the guideline, no prediction can be made using this values. For precautionary measures, “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola” is classified voluntarily as irritating to eyes (GHS Category 2).
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