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EC number: 854-058-4 | CAS number: 58625-89-1
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 December 2020 - 18 December 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (Z)‐ethyl 2‐methylpent‐3‐enoate
- EC Number:
- 854-058-4
- Cas Number:
- 58625-89-1
- Molecular formula:
- C8H14O2
- IUPAC Name:
- (Z)‐ethyl 2‐methylpent‐3‐enoate
- Test material form:
- liquid
Constituent 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:
- EpiDerm Skin Model (EPI-200, Lot no.: 33783 Kit F)
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- All cells used to produce Epiderm™ are purchased or derived from tissue obtained by MatTek
Corporation from accredited institutions.
- Cells are screened for potential biological contaminants (HIV-1, Hepatitis B, Hepatitis C, bacteria, yeast and fungi)
- Surface: 0.6 cm²
- The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: All incubations, with the exception of the test item incubation of 3 minutes at room temperature, were carried out in a controlled environment at 37.0 ± 1.0°C (actual range 35.9 - 37.3°C)
REMOVAL OF TEST MATERIAL AND CONTROLS
- After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test item.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2 replicates per exposure duration, two negative controls per exposure duration and two positive controls per exposure duration
ACCEPTABILITY CRITERIA
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be within the laboratory historical control data range and the acceptance limits of OECD431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8).
b) The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%.
INTERPRETATION (See table 1)
A test item is considered corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability ≥ 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Fifty μL of the undiluted test item was added into the 6-well plates on top of the skin tissues.
- Duration of treatment / exposure:
- 3 minutes or 1 hour
- Number of replicates:
- 2 replicates per exposure duration
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute treatment
- Value:
- 98
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1-hour treatment
- Value:
- 65
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- MTT INTERFERENCE
- The test item was checked for color interference in aqueous conditions. Addition of the test item to Milli-Q and isopropanol resulted after subtraction of the blank in an OD of -0.0027 and 0.0001, respectively. Therefore it was concluded that the test item did not induce color interference.
In addition, because no color change was observed in the presence of MTT it was concluded that the test item did not interact with the MTT endpoint.
RESULTS
- Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 98% and 65% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive.
ACCEPTABILITY OF RESULTS
- The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. The mean relative tissue viability following the 1-hour exposure to the positive control was 7.2%.
- In the range of 20 - 100% viability the Coefficient of Variation between replicates of the negative control tissues was ≤ 14%, indicating that the test system functioned properly.
- The Coefficient of Variation between replicates of the test item tissues was 33% for the 1-hour procedure. Although this value exceeds the acceptability criteria of 30%, all individual viabilities were in the same classification category, therefore the test outcome was considered to be valid.
Any other information on results incl. tables
Table 2. Mean Absorption in the in vitro Skin Corrosion Test with Ethyl 2-methyl-3-pentenoate
| 3-minute application | 1-hour application | ||||||||
A (OD570) | B (OD570) | Mean (OD570) | SD | A (OD570) | B (OD570) | Mean (OD570) | SD | |||
Negative control | 1.784 | 1.776 | 1.780 | ± | 0.006 | 1.863 | 1.600 | 1.732 | ± | 0.186 |
Test item | 1.647 | 1.832 | 1.739 | ± | 0.131 | 1.340 | 0.898 | 1.119 | ± | 0.313 |
Positive control | 0.111 | 0.130 | 0.120 | ± | 0.013 | 0.144 | 0.105 | 0.125 | ± | 0.027 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In table 1 the values are corrected for background absorption (0.0434). Isopropanol was used to measure the background absorption.
Table 3. Mean Tissue Viability in the in vitro Skin Corrosion Test with Ethyl 2-methyl-3-pentenoate
| 3-minute application viability (percentage of control) | 1-hour application viability (percentage of control) |
Negative control | 100 | 100 |
Test item | 98 | 65 |
Positive control | 6.8 | 7.2 |
Table 4. Coefficient of Variation between Tissue Replicates
| 3 minute | 1 hour |
Negative control | 0.4 | 14 |
Test item | 10 | 33 |
Positive control | 14 | 27 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Applicant's summary and conclusion
- Interpretation of results:
- other: Not skin corrosive in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The substance is not corrosive to the skin.
- Executive summary:
In an in vitro skin corrosion test using a human skin model (EpiDerm Skin Model) performed according to OECD TG 431 and GLP principles, the influence of the test substance on the viability of human skin was tested. The test item was applied undiluted (50 μL) was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability of 7.2% after the 1-hour exposure.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between replicates of the negative control tissues was ≤ 14%, indicating that the test system functioned properly.
The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 98% and 65%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive.In conclusion, the test substance is not corrosive to the skin in accordance with EU CLP (EC no1272/2008 and its amendments).
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