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EC number: 906-089-0 | 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:
- 19 October 2020 - 23 November 2020
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Geranyl propionate
- EC Number:
- 203-344-1
- EC Name:
- Geranyl propionate
- Cas Number:
- 105-90-8
- Molecular formula:
- C13H22-O2
- IUPAC Name:
- (2E)‐3,7‐dimethylocta‐2,6‐dien‐1‐yl propanoate
- Test material form:
- liquid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 20 EKIN 043 and 20 EKIN 047)
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Adult human donors
- Absence verified of HIV1 and 2 antibodies, hepatitis C antibodies, hepatitis B antigen HBs, bacteria, fungus and mycoplasma.
- This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Expiration date: 26 October 2020 (20 EKIN 043) and 23 November 2020 (20 EKIN 047)
TEMPERATURE USED FOR TEST SYSTEM
- All incubations, with the exception of the test item incubation of 15 minutes at room temperature, were carried out in a controlled environment, at 37.0 ± 1.0°C (actual range 35.9 - 37.3°C).
- Humid atmosphere of 80-100% (actual range 80-95%), containing 5.0 +/- 0.5% CO2 in air in the dark.
REMOVAL OF TEST MATERIAL AND CONTROLS
- After the exposure period of 15 ± 0.5 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test item.
TEST FOR COLOR INTERFERENCE BY THE TEST ITEM
- To assess the color interference, 50 μL of the test item or 50 μL sterile Milli-Q water as a negative control was added to 1.0 mL Milli-Q water.
- The mixture was incubated for at least 1 hour at 37.0 ± 1.0°C in the dark.
- 50 μL of the test item or 50 μL sterile Milli-Q water as a negative control was added to 2.0 mL isopropanol.
- The mixture was incubated for 2 - 3 hours at room temperature with gentle shaking.
- If after subtraction of the negative control, the OD for the test item solution is >0.08, the test item is considered as possibly interacting with the MTT measurement.
TEST FOR REDUCTION OF MTT BY THE TEST ITEM
- 50 μL of the test item was added to 1 mL MTT solution (1 mg/mL MTT in phosphate buffered saline).
- The mixture was incubated for approximately 3 hours at 37.0 ± 1.0°C in the dark.
- A negative control, 50 μL sterile Milli-Q water was tested concurrently.
- If the MTT solution color turned blue / purple or if a blue / purple precipitate was observed the test item interacts with MTT.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours at 37.0+/-1.0 C in the dark; negative control milli-Q water
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3 tissues per test item together with negative and positive
controls.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 runs
ACCEPTABILITY CRITERIA
The in vitro skin irritation test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the acceptance limits of OECD439 (lower acceptance limit ≥0.6 and upper acceptance limit ≤1.5) and the Standard Deviation value (SD) of the % viability should be ≤18.
b) The mean relative tissue viability of the positive control should be ≤40% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18.
c) The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18.
INTERPRETATION (See Table 1)
A test item is considered irritant in the skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
A test item is considered non-irritant in the in vitro skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Twenty-five μL of the undiluted test item on top of the skin tissues - Duration of treatment / exposure:
- 15 ± 0.5 minutes at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C.
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- First experiment
- Value:
- 49
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Second experiment
- Value:
- 29
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- FIRST EXPERIMENT
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 49% ± 59%. Since the mean relative tissue viability for the test item was below or equal to 50% after 15 ± 0.5 minutes treatment it is considered to be irritant. However, since the individual viabilities (16%, 16% and 117%) were spread over two categories, the experiment was
repeated.
SECOND EXPERIMENT
In the repeat experiment, the relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 29% ± 16% (individual viabilities of 21%, 48% and 19%). Since the treated tissues had an individual cell viability after exposure to the test item below 50% and the mean relative tissue viability for the test item in the repeat experiment was well below 50% after 15 ± 0.5 minutes treatment, the test item is considered to be irritant.
ACCEPTANCE OF RESULTS
The positive control had a mean cell viability of 3.7% ± 1.1 and 5.2% ± 22.9 (experiment 1 and 2 respectively) after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 16%, indicating that the test system functioned properly. Except for the three tissues treated with test item in experiment 1, which had a standard deviation of 59%. Therefore, the repeat experiment was performed.
Any other information on results incl. tables
Table 2. Mean Absorption in the In Vitro Skin Irritation Test with Geranyl Propionate
First experiment:
| A (OD570) | B (OD570) | C (OD570) | Mean (OD570) |
| SD |
Negative control | 1.037 | 1.054 | 1.127 | 1.072 | ± | 0.048 |
Test item | 0.167 | 0.166 | 1.255 | 0.529 | ± | 0.628 |
Positive control | 0.047 | 0.027 | 0.046 | 0.040 | ± | 0.011 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.04373). Isopropanol was used to measure the background absorption.
Repeat experiment:
| A (OD570) | B (OD570) | C (OD570) | Mean (OD570) |
| SD |
Negative control | 1.091 | 1.131 | 0.933 | 1.052 | ± | 0.104 |
Test item | 0.220 | 0.506 | 0.203 | 0.310 | ± | 0.170 |
Positive control | 0.037 | 0.038 | 0.090 | 0.055 | ± | 0.030 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.04345). Isopropanol was used to measure the background absorption.
Table 3. Mean Tissue Viability in the In Vitro Skin Irritation Test with Geranyl Propionate
First experiment:
| Mean tissue viability (percentage of control) | Standard deviation (percentage) |
Negative control | 100 | 4.4 |
Test item | 49 | 59 |
Positive control | 3.7 | 1.1 |
Second experiment:
| Mean tissue viability (percentage of control) | Standard deviation (percentage) |
Negative control | 100 | 9.9 |
Test item | 29 | 16 |
Positive control | 5.2 | 2.9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance causes skin irritation in the in vitro skin irritation test (OECD guideline 439).
- Executive summary:
An in vitro skin irritation test according to OECD guideline 439 and in accordance with GLP principles was performed. The test item was applied undiluted (25 μL), directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 49%. Since the mean relative tissue viability for the test item was below or equal to 50% after 15 ± 0.5 minutes treatment it is considered to be irritant. However, since the individual viabilities (16%, 16% and 117%) were spread over two categories, the experiment was repeated. In the repeat experiment, the relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 29% (individual viabilities of 21%, 48% and 19%). Since the treated tissues had an individual cell viability after exposure to the test item below 50% and the mean relative tissue viability for the test item in the repeat experiment was well below 50% after 15 ± 0.5 minutes treatment, the test item is considered to be irritant. The positive control had a mean cell viability of 3.7% and 5.2% (experiment 1 and 2 respectively) after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 16%, indicating that the test system functioned properly. Except for the three tissues treated with test item in experiment 1, which had a standard deviation of 59%. Therefore, the repeat experiment was performed. In conclusion, the test substance causes skin irritation in the in vitro skin irritation test (OECD guideline 439).
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