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EC number: 939-728-7 | 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
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-16 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with generally accepted scientific standards and described in sufficient details
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Evaluation of the primary ocular irritation after application of test item on a reconstructed human corneal epithelium model by quantification of cellular viability by MTT reduction test (Mosmann, T. 1983) and determination of exposure time that causes 50% of cell mortality (T50).
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1r,4r)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; (1s,4s)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; 2-[(1r,4r)-4-methylcyclohexyl]propan-2-yl acetate; 2-[(1s,4s)-4-methylcyclohexyl]propan-2-yl acetate
- EC Number:
- 939-728-7
- Molecular formula:
- C12H22O2
- IUPAC Name:
- (1r,4r)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; (1s,4s)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; 2-[(1r,4r)-4-methylcyclohexyl]propan-2-yl acetate; 2-[(1s,4s)-4-methylcyclohexyl]propan-2-yl acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Menthanyl acetate multiconstituent
- Physical state: Colourless to slightly amber liquid
- Analytical purity: 98.4 %
- Composition of test material (%):Trans para menthanyl 1 (17.0 %), trans para menthanyl 8 (28.9 %), cis para menthanyl 8 (32.5 %), cis para menthanyl 1 (20.0 %) and others (1.6 %)
- Lot/batch No.: 120922
- Purity test date: 05 July 2011
- Date of receipt: 16 April 2012
- Expiration date of the lot/batch: 04 July 2012
- Storage condition of test material: Stored at 6 ± 3 °C in darkness
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: sodium chloride (0.9 % w/v) in sterile water; positive control: 1.5 % (w/w) SDS in sterile water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
- Concentration: Test material: undiluted; negative control: sodium chloride (0.9 % w/v); positive control: 1.5 % (w/w) SDS solution - Duration of treatment / exposure:
- - Test item: 10 ± 2 min, 1 h ± 10 min and 3 h ± 30 min
- Positive control: 10 ± 2 min and 1 h ± 10 min
- Negative control: 3 h ± 30 min - Observation period (in vivo):
- Post-exposure period: approximately 2 h
- Number of animals or in vitro replicates:
- Test item, negative control and positive control were tested in duplicate
- Details on study design:
- TEST SYSTEM:
- Cell system used: Human reconstructed corneal epithelium model of 0.5 cm² (5 days of culture), from immortalized human corneal epithelial cells from the cell line HCE (Human Corneal Epithelial cells), cultivated in chemically defined medium
- Source: SKINETHIC Laboratories (Lyon, France)
METHODOLOGY:
- Non-specific MTT reduction: 10 µL of the test item was added to each well of a 12-wells plate containing 2 mL of MTT solution (0.3 mg/mL) and colour of the solution was checked after incubation for 3 h ± 5 min at 37 ± 1 °C, 5 ± 1 % CO2, 95 ± 5 % humidity (CO2 incubator).
- MTT conversion assay: The epithelial units were transferred from the kit into maintenance medium filled wells and pre-incubated at 37 ± 1 °C until the following day. After pre-incubation, 30 µL of test material, in duplicate, were applied to the epithelium model for 10 ± 2 min, 1 h ± 10 min and 3 h ± 30 min at room temperature. Contact timepoint for negative control was 3 h ± 30 min and for positive controls were 10 ± 2 min and 1 h ± 10 min. At the end of each incubation period, each epithelium was rinsed under a jet of PBS+ (10 mL), transferred into a new well containing MTT solution and incubated for 1 h ± 10 min in CO2 incubator. Each epithelium was then transferred into a new 24 wells plate containing isopropanol (1 mL). After agitating for 1 h ± 10 min, each extract (200 μL/well) was transferred into a 96 wells microplate and optical density was recorded at 570 nm with a plates reader (blank = isopropanol). For each treated tissue the viability was expressed as mean percentage of cellular viability relative to the negative control and the exposure time that causes 50% of cell mortality (T50) was determined by linear regression analysis.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: T50
- Basis:
- mean
- Time point:
- other: 173.11 min
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Negative control:
- Mean OD: 1.152
T50 values:
- Positive control: 33.49 min
- Test material: 173.11 min
- See table 7.3.2/2 for more data - Other effects:
- - Non-specific MTT reduction: MENTHANYL ACETATE MULTICONSTITUENT did not interact with MTT
Any other information on results incl. tables
Table 7.3.2/2: Optical density readings and % viability
|
Contact Timepoint (min.) |
O.D. 1 |
O.D. 2 |
Mean O.D. |
% viability |
Negative control |
180 |
1.179 |
1.125 |
1.152 |
100 % |
Positive control |
10 |
1.093 |
1.000 |
1.047 |
91 % |
60 |
0.054 |
0.030 |
0.042 |
4 % |
|
Test item |
10 |
1.195 |
1.244 |
1.220 |
106 % |
60 |
1.063 |
1.041 |
1.052 |
91 % |
|
180 |
0.560 |
0.524 |
0.542 |
47 % |
O.D.: Optical density
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: See table 7.3.2/1
- Conclusions:
- Under the test conditions, the T50 value of the test item, MENTHANYL ACETATE MULTICONSTITUENT, was between 60 and 180 min therefore it was considered as slightly irritant when applied on a human reconstructed corneal epithelium.
- Executive summary:
In an in vitro eye irritation study performed in compliance with GLP, 30 µL of the test item, MENTHANYL ACETATE MULTICONSTITUENT was applied to the human reconstructed corneal epithelium model (in duplicate) for 10 ± 2 min, 1 h ± 10 min and 3 h ± 30 min at room temperature. Contact timepoint for negative control (sodium chloride 0.9 % w/v) was 3 h ± 30 min and 10 ± 2 min and 1 h ± 10 min for positive control (SDS 1.5% w/w). At the end of each incubation period, each epithelium was rinsed, transferred to new well containing MTT solution and incubated for 1 h ± 10 min in CO2 incubator. Each epithelium was then transferred into a new well plate containing isopropanol (1 mL). After agitating for 1 h ± 10 min, the extract (200 μL/well) was transferred into a 96 wells microplate and optical density was recorded at 570 nm with a plates reader. For each treated tissue the viability was expressed as mean percentage of cellular viability relative to the negative control and the exposure time that causes 50% of cell mortality (T50) was determined by linear regression analysis.
T50 value for the test item was 173.11 min. Optical density value for the negative control was 1.152 and T50 value for positive control was 33.49 min and thus confirmed the validity of the test.
Under the test conditions, the T50 value of the test item, MENTHANYL ACETATE MULTICONSTITUENT, was between 60 and 180 min therefore it was considered as slightly irritant when applied on a human reconstructed corneal epithelium.
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