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EC number: 922-963-4 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-03-20 and 2015-06-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of trans-5-hexyldihydro-4-methylfuran-2(3H)-one and cis-5-hexyldihydro-4-methylfuran-2(3H)-one
- EC Number:
- 922-963-4
- Molecular formula:
- C11H20O2
- IUPAC Name:
- Reaction mass of trans-5-hexyldihydro-4-methylfuran-2(3H)-one and cis-5-hexyldihydro-4-methylfuran-2(3H)-one
Constituent 1
Test animals
- Species:
- other: EPISKIN Standard Model
- Strain:
- other: EPISKIN Standard Model
Test system
- Type of coverage:
- other: 30 µL (47 µL/cm2) of the undiluted test item was dispensed directly on top the skin surface.
- Preparation of test site:
- other: The epidemis in the upper wells were preincubated for 60 minutes (37 ± 1.5°C, 5 ± 1% CO2, 95 ± 5% RH). The inserts were transferred from upper wells into the lower wells and preincubation was continued for 4.25 hours (37 ± 1.5°C, 5 ± 1% CO2, 95 ± 5% RH).
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 5% Sodium Lauryl Sulphate in deionised water (positive control) and Dulbecco's Phosphate Buffered Saline (negative control) were used.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL (47 µL/cm2) - Duration of treatment / exposure:
- The complete exposure period of the skin equivalents was 60 minutes. According to the protocol of the test kit supplier, the 6-well plates were put into the incubator for 35 minutes at 37 ± 1.5 °C, 5 ± 0.5 % CO2 within 60 minutes. Outside the incubator the 6-well plates were placed in a sterile bench at room temperature for 25 minutes in sum.
- Observation period:
- not applicable
- Number of animals:
- Three replicates per test, negative control and positive control respectively were used.
- Details on study design:
- TEST SITE
- Area of exposure: surface of epidermis 0.6 cm2
REMOVAL OF TEST SUBSTANCE
- Washing: Tissues were gently rinsed with DPBS at least 15 times and afterwards submerged in DPBS at least three times. Subsequently, the tissue was once again rinsed with sterile DPBS from the inside and the outside. Excess DPBS was removed by gently shaking the tissues and blotting the bottom with sterile blotting paper. The tissues were carefully dried using sterile cotton tipped swap.
- Time after start of exposure: 60 min after exposure
SCORING SYSTEM: Cell viability by using the MTT test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (test item)
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min treatment + 42 h post exposure. Remarks: 25.5% relative absorbance (to negative control). (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (positive control)
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 min treatment + 42 h post exposure. Remarks: 6.8% relative absorbance (to negative control). (migrated information)
In vivo
- Irritant / corrosive response data:
- Cell viability: negative control
No. 1: 110.3%
No. 2: 98.8%
No. 3: 90.8%
Mean: 100%
Mean absorbance: 1.532
The absorbance value obtained for the positive control was 0.104 and this result corresponds to 6.8% viability when compared to the results obtained from the negative controls.
Each calculated standard deviation value (SD) for the % viability was below 18. All validity criteria were within acceptable limits and therefore the study can be considered as valid.
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 25.5% (threshold for irritancy: ≤ 50%), consequently the test item was irritant to skin. - Other effects:
- The test item did not reduce MTT (test for direct MTT reduction), and it did not change colour when mixed with deionised water (test for colour interference). Also its intrinsic colour was not intensive. Consequently, additional tests with freeze-killed or viable tissues were not necessary.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test substance is irritant to skin.
- Executive summary:
The irritation potential of the test substance was investigated by using the in vitro Human Skin Model Test (OECD 439, EU B.46). Each three tissues of the human skin model EpiDerm were treated with 30 µL of the test item, the negative (Dulbecco's Phosphate Buffered Saline) or the positive control (5% sodium lauryl sulfate) for 60 minutes. Cell viability was determined using the MTT assay. The absorbance value obtained for the positive control was 0.104 and this result corresponds to 6.8% viability when compared to the results obtained from the negative controls. After treatment with the test item Aprifloren the mean relative absorbance value decreased to 25.5% compared to the relative absorbance value of the negative control. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential. Thus, the test substance was considered to be irritant to skin under the test conditions chosen.
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