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EC number: 203-569-5 | CAS number: 108-29-2
- 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:
- 2020-07-13 to 2020-12-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 31 July 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- γ-valerolactone
- EC Number:
- 203-569-5
- EC Name:
- γ-valerolactone
- Cas Number:
- 108-29-2
- Molecular formula:
- C5H8O2
- IUPAC Name:
- 5-methyloxolan-2-one
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch number of test material: Grosss 542
- Expiration date of the batch: 04 June 2022
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not indicated
- Justification for test system used:
- OECD accepted in vitro model system as part of a turnkey test strategy to assess the skin irritation potential of chemicals
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ 200 kit (MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia)
- Tissue batch number: 30881
- Date of initiation of testing: 2020-07-22 (Date of quality check)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature (for the 3-minutes incubation period) or at 37°C (for 1-hour incubation period)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were washed with sterile PBS (number and volume not indicated)
- Observable damage in the tissue due to washing: Not indicated
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mL of a 1.0 mg/mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability and barrier function: MatTek determines the ET50 value following exposure to Triton X-100 (1%) for each EpiDermTM batch. The ET50 must fall within an established range based on a historical database of results (table 1)
NUMBER OF REPLICATE TISSUES: 2 tissues per incubation time
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
No direct MTT interference occured, thus no freeze-killed control tissues were used.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: One test sequence was conduced using 2 replicate tissues per time point
PREDICTION MODEL / DECISION CRITERIA
- 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:
- TEST MATERIAL
- Amount applied: 30 µL
NEGATIVE CONTROL
- Amount applied: 50 µL deionized water
POSITIVE CONTROL
- Amount applied: 50 µL 8 N potassium hydroxide solution
- Concentration: 8 N - Duration of treatment / exposure:
- 3 min and 1 hour treatments
- Duration of post-treatment incubation (if applicable):
- No post-incubation period
- Number of replicates:
- 2 tissue replicates per time point
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1 (1 hour incubation time, 2 tissue replicates)
- Value:
- 21
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1 (3 minutes incubation time, 2 tissue replicates)
- Value:
- 86.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not indicated
- Direct-MTT reduction: No
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes (see table 2-4)
- Acceptance criteria met for positive control: Yes (see table 2-4)
- Acceptance criteria met for variability between replicate measurements: Yes (see table 2-4)
- Range of historical values if different from the ones specified in the test guideline: No
Any other information on results incl. tables
Table 3: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficients of variation (exposure period 3 min)
Test substance identification |
| tissue 1 | tissue 2 | mean | SD | CV [%] |
NC | mean OD570 | 2.085 | 2.131 | 2.108 |
|
|
Viability [% of NC] | 98.9 | 101.1 | 100.0 | 1.5 | 1.5 | |
Test item | mean OD570 | 1.735 | 1.916 | 1.825 |
|
|
Viability [% of NC] | 82.3 | 90.9 | 86.6 | 6.1 | 7.0 | |
PC | mean OD570 | 0.171 | 0.192 | 0.181 |
|
|
Viability [% of NC] | 8.1 | 9.1 | 8.6 | 0.7 | 8.0 |
Table 4: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficients of variation (exposure period 1 hour)
Test substance identification |
| tissue 1 | tissue 2 | mean | SD | CV [%] |
NC | mean OD570 | 2.083 | 1.936 | 2.010 |
|
|
Viability [% of NC] | 103.6 | 96.4 | 100.0 | 5.2 | 5.2 | |
Test item | mean OD570 | 0.440 | 0.403 | 0.421 |
|
|
Viability [% of NC] | 21.9 | 20.0 | 21.0 | 1.3 | 6.2 | |
PC | mean OD570 | 0.061 | 0.063 | 0.062 |
|
|
Viability [% of NC] | 3.0 | 3.1 | 3.1 | 0.1 | 2.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The Skin Corrosion Test according to OECD guideline 431 showed no skin corrosive potential of gamma-Valerolacton.
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