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EC number: 203-761-9 | CAS number: 110-38-3
- 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:
- From 24 November 2017 to 14 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- No analysis certificate of the episkin model was given.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl decanoate
- EC Number:
- 203-761-9
- EC Name:
- Ethyl decanoate
- Cas Number:
- 110-38-3
- Molecular formula:
- C12H24O2
- IUPAC Name:
- ethyl decanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: From the sponsor, batch : 16090585
- Expiration date of the lot/batch: 19 september 2018
- Purity test date: 22 September 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions:at least 6 months from the manufacture date
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable, the test item was used pure
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material)
In vitro test system
- Test system:
- artificial membrane barrier model
- Remarks:
- Reconstructed human epidermis
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not applicable
- Source strain:
- other: not applicable
- Justification for test system used:
- The present test is proposed as an alternative in vitro approach to assess the skin irritant potential of chemicals or cosmetic ingredient.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM
- Tissue batch number(s): lot 17-EKIN-047
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 21 November 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: thoroughly rinsed with PBS
- Observable damage in the tissue due to washing: not specified
- Modifications to validated SOP:no modification
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: not specified
- Wavelength: 570nm
- Filter: not filter used
- Filter bandwidth: not applicable
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes
- Barrier function: yes
- Morphology: stratified differentiated epidermis derived from human keratinocytes
- Contamination: not specified
- Reproducibility:yes
NUMBER OF REPLICATE TISSUES: triplicates were used
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues (if applicable): Freezed-killed tissue
- N. of replicates : triplicates
- Method of calculation used: % viability = [OD mean of treated condition / OD mean of control condition] x 100
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 independant tests :pretest with interference and MTT reduction test and main test
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 30 minutes exposure and 42 hours post incubation is less than 50%.
- The test substance is considered to be non-irritant to skin if the viability after 30 minutes exposure and 42 hours post incubation is greater than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL/cm2 corresponding to 19 µL (0.38cm2)
- Concentration (if solution): pure
VEHICLE
Not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 19 µL
- Concentration (if solution): pure
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 19µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- triplicates were used
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Negative control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Test item
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Positive control
- Value:
- 17
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: the 5% SDS was used as positive control and showed proficiency of the test system to detect cellular cytotoxicity
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: conform
- Acceptance criteria met for positive control: conform
- Acceptance criteria met for variability between replicate measurements: conform
- Range of historical values if different from the ones specified in the test guideline: Historical values of positive control : 14±4% ; Positive control values in the test : 17%. Conform
Any other information on results incl. tables
Table 1 :Results
Condtion |
Optical Density Mean |
Cellular viability |
Negative control |
1.522 ± 0.012 |
100 |
Positive control |
0.257 ± 0.015 |
17 |
Test item |
1.523 ± 0.016 |
100 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, the test item when applied on the EpiSkin model for 15 minutes did not induce a decrease of cellular viability. Hence, according to the CLP criteria, the test item, caprate ethyl, was not classified for skin irritation.
- Executive summary:
This GLP compliant study was performed in order to assess the potential skin irritation potential of the test item, caprate ethyl. This study was performed according to the OECD TG 439 method.
EpiSkinTM was used as test system in this study. 19 µL of caprate ethyl was applied on the EpiSkinTM for 15 minutes. Buffered saline solution (PBS) was used as negative control and 5% Sodium dodecyl sulfate (SDS) was used as positive control. Triplicates were used for each condition. The 15 minutes exposure period was followed by a 42 hours post incubation period. After this step, the viability of the EpiSkinTM model was measured by a MTT assay.
The postive control induceda decrease of cellular viability (17% of viability). The negative control did not induced a viability decrease. The viability of the test system was 100% when exposed to the test item.
The acceptance criteria of the assay was considered as validated.
Based on the result of this study, the test item whan applied on the EpiSkin model for 15 minutes did not induce a decrease of cellular viability. Hence, according to the CLP criteria, the test item, caprate ethyl, was not classified for skin irritation.
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