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EC number: 263-336-9 | CAS number: 61931-80-4
- 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
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- Flash point
- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- Environmental data
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- 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:
- 21-01-2014 until 24-01-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,5-dimethyl-1-vinylhept-4-enyl acetate
- EC Number:
- 263-336-9
- EC Name:
- 1,5-dimethyl-1-vinylhept-4-enyl acetate
- Cas Number:
- 61931-80-4
- Molecular formula:
- C13H22O2
- IUPAC Name:
- (6E)-3,7-dimethylnona-1,6-dien-3-yl acetate
- 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: SkinEthic Laboratories, Lyon, France
- Source strain:
- other: Not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Skin Ethic RHE / S / 17
- Tissue batch number(s): 14 RHE 0101
- Production date: 20 January 2014
- Shipping date: 21 January 2014
- Delivery date: 21 January 2014
- Date of initiation of testing: 21 january 2014
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1 mL PBS, 25 times
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: SpectraMax M5 (Molecular Devices)
- Wavelength: 570 nm
- Filter / Filter bandwidth / Linear OD range of spectrophotometer: No data
NUMBER OF REPLICATE TISSUES: Test was performed in triplicate
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the mean tissue viability after exposure is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the mean tissue viability after exposure is more than 50%.
ACCEPTABIILITY CRITERIA
- The absolute absorbance at 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean absorbance of the three negative controls is ≥ 1.2 and ≤2.5
- An assay is meeting the acceptance criterion if the mean relative tissue viability of the positive control is < 40%.
- The standard deviations (calculated from individual precental tissue viabilities) among tissues of the same treatment group should be ≤18%.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Cell viability at day 17 is 1.475 +/- 0.021 where an O.D. of > 0.7 is accepted
- Barrier function: Exposure time inducing 50% viability (using Triton X-100 1%) is 4.8h where 4-10h is accepted
- Morphology / contamination: The culture and histology of the skin is found to be conform (sufficient cell layers and good cell growth and sterility
- Reproducibility: The system is fully reproducible as it is commercially being sold by SkinEthic. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 16 µL
NEGATIVE CONTROL
- Amount(s) applied: 16µL
POSITIVE CONTROL
- Amount(s) applied: 16 µL
- Concentration: 5% in deionised water - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 9.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: not reported
- Direct-MTT reduction: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: No data
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Summary of results
Dose group |
Absorbance 570 nm |
Mean Absorbance of 3 tissues** |
Relative viability [%] Tissue 1, 2, 3** |
Relative viability [% of negative control]** |
Standard deviation [%]** |
||
Tissue 1* |
Tissue 2* |
Tissue 3* |
|||||
Negative control (PBS) |
2.091 |
2.178 |
2.127 |
2.132 |
98.1 |
100.0 |
2.0 |
102.2 |
|||||||
99.8 |
|||||||
Positive control (5% w/v SDS) |
0.013 |
0.016 |
0.015 |
0.015 |
0.6 |
0.7 |
0.1 |
0.7 |
|||||||
0.7 |
|||||||
Test substance |
0.237 |
0.152 |
0.190 |
0.193 |
11.1 |
9.1 |
2.0 |
7.2 |
|||||||
8.9 |
*Mean of three replicate wells (per tissue) after blank correction
**Calculation based on exact means
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritant)
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of this test, the relative mean tissue viability for the test item determined to be 9.1%. This value is below the threshold for irritancy of ≤50%. Based on the results obtained, it can be concluded that Ethyllinalyl acetate is at least an irritant to skin and further research is needed to be able to assign a classification in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The test substance was tested according to OECD 439 (non-GLP) with the in vitro reconstructed human epidermis model. 16µL test substance was applied and the tissues were exposed for 42 minutes at room temperature, in triplicate. After exposure the tissues were rinsed with PBS. After 42 hours post-incubation a MTT assay was performed to determine the cell viability. Negative and positive controls were run in parallel and acceptance criteria were met. Under the conditions of this test, the relative mean tissue viability for the test item determined to be 9.1%. This value is below the threshold for irritancy of ≤50%. Based on the results obtained, it can be concluded that Ethyllinalyl acetate is at least an irritant to skin and further research is needed to be able to assign a classification in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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