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EC number: 206-031-8 | CAS number: 292-64-8
- 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:
- weight of evidence
- Study period:
- 2021-08-31 to 2021-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40bis IN VITRO SKIN CORROSION: RECONSTRUCTED HUMAN EPIDERMIS (RhE) TEST METHOD
- Version / remarks:
- 2019-07-31
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2019-06-14
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cyclooctane
- EC Number:
- 206-031-8
- EC Name:
- Cyclooctane
- Cas Number:
- 292-64-8
- Molecular formula:
- C8H16
- IUPAC Name:
- cyclooctane
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Justification for test system used:
- The reconstructed human epidermis model in vitro method is an accepted in vitro method to replace animal testing. The human skin RHE™ model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic™ RHE-model RHE/S/17 (Episkin/SkinEthic Laboratories, Lyon, France)
- Tissue batch number: 21-RHE-104
- Expiry date: 2021-09-06
- Date of initiation of testing: 2021-08-31
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: minimum volume of 20 mL DPBS, gentle rinsing
- Observable damage in the tissue due to washing: Not specified
- Modifications to validated SOP: No.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours (± 15 minutes)
- Spectrophotometer: ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany
- Wavelength: 570 nm
- Filter: Not specified
- Linear OD range of spectrophotometer: Not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Please refer to “Any other information on materials”.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Pre-tests for MTT-reducing capacity and colorant properties of the test item were conducted. No such properties were detected and therefore, no additional controls were needed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15 %.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is greater than or equal to 15 %.- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 40 ± 3 µL per tissue
- Duration of treatment / exposure:
- test item and negative control: 3 min and 1 h
positive control: 1 h - Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- 2 per substance and time point
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean 1 h exposure
- Value:
- 90.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean 3 min exposure
- Value:
- 102
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Not specified.
- Direct-MTT reduction: No.
- Colour interference with MTT: No.
ACCEPTANCE OF RESULTS:
Please refer to “Any other information on results”.
Any other information on results incl. tables
The results of the reconstructed human epidermis model:
Group | Tissue 1 | Tissue 2 | Mean | CV | ||||
OD | Viability | OD | Viability | OD | Viability | Viability | ||
Negative Control | 3 min | 1.697 | 100.8 % | 1.668 | 99.1 % | 1.683 | 100.0 % | 1.2 % |
1 hour | 1.561 | 101.5 % | 1.515 | 98.5 % | 1.538 | 100.0 % | 2.1 % | |
Positive Control | 1 hour | 0.009 | 0.6 % | 0.008 | 0.5 % | 0.009 | 0.6 % | 16.7 % |
Test item | 3 min | 1.653 | 98.2 % | 1.779 | 105.7 % | 1.716 | 102.0 % | 5.2 % |
1 hour | 1.362 | 88.6 % | 1.413 | 91.9 % | 1.388 | 90.3 % | 2.5 % |
Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
| Acceptance Criterion | Result |
Negative control OD | ≥0.8 and ≤3.0 | 1.515 to 1.697 |
Acceptance Criteria stated by Episkin/SkinEthic Laboratories:
| Acceptance Criterion | Result |
Mean OD negative control | ≥0.8 and ≤3.0 | 1.683 (3 min) 1.538 (1 hour) |
Mean viability positive control | < 15 % after 1-hour exposure | 0.6 % |
Range between identically treated tissues with test item | < 30 % | 7.6 % (3 min) 3.7 % (1 hour) |
Acceptability of the Positive and Negative Control based on Historical Data of the Testing Laboratory:
| Acceptance Criterion | Result |
Mean OD negative control | ≥1.605 (3 min) ≥1.408 (1 hour) | 1.683 (3 min) 1.538 (1 hour) |
Mean viability positive control | ≤1.01 % | 0.6 % |
Negative Control, Positive Control and Test Substance Data Acceptance Criteria stated by the Testing Laboratory:
| Group | Acceptance Criterion | Result |
Range between identically treated tissues | Negative control | < 30 % | 1.7 % (3 min) 3.0 % (1 hour) |
Positive control | < 30 % | 20.0 % (1 hour) | |
Test substance | < 30 % | 7.6 % (3 min) 3.7 % (1 hour) |
The study met all acceptance criteria.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not considered as corrosive to skin.
- Executive summary:
The objective of the study conducted according to OECD TG 431 was to investigate the potential of the test item to induce skin corrosion in an in vitro human skin model. The test item was applied topically to a human reconstructed skin model followed by determination of the cell viability. Cell viability was determined by enzymatic conversion of vital dye MTT into a blue formazan salt and measurement of the formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the skin corrosion potential. Duplicates of the human skin RHE-model were treated with the test item or the negative control for 3 minutes and additional 1 hour. Duplicates with the positive control were only treated for 1 hour. 40 ± 3 µL of the liquid test item, the negative control (deionised water) or the positive control (potassium hydroxide, 8N) were applied to the tissues. After treatment with the positive control the mean viability value was 0.6 % and, thus, lower than the historically established threshold of 1.01 %. After treatment with the negative control the mean ODs were 1.683 (3 minutes exposure) and 1.538 (1 hour exposure) and, thus , higher than the historically established thresholds of 1.605 and 1.408, respectively. Thus, the acceptance criteria were met. Following treatment with the test item, the tissue viability was ≥50 % after 3 minutes exposure (mean viability: 102.0 %) and ≥15 % after 1 hour exposure (mean viability: 90.3 %). Therefore, under the conditions of the present study, the test item is not considered to possess a corrosive potential to skin.
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