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EC number: 807-159-2 | CAS number: 69701-99-1
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Apr 2017 - 02 Jun 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS
- Version / remarks:
- published 2003, last (6th) revision 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- EC Number:
- 807-159-2
- Cas Number:
- 69701-99-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch: 09892701
- Purity: 99.9%
- Appearance: Colourless liquid
- Expiry Date: 06 March 2018
- Storage Conditions: At room temperature, under protection of sunlight
- Stability in Solvent: Not indicated by the Sponsor
- Purpose of Use: Industrial chemical
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The EpiSkin™ tissue consists of NHEK, which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Source strain:
- not specified
- Details on animal used as source of test system:
- N/A
- Justification for test system used:
- Because systemic reactions play a minor role in modulating local skin toxicity potential of chemicals, skin irritation potential may be predicted by in vitro systems, provided they are sufficiently complex to mimic human skin barrier and cell reactivity. In an international validation study performed by ECVAM, the in vitro skin irritation test using the human skin models EpiSkin™ and EpiDerm™ and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt have turned out as a sufficiently promising predictor for skin irritancy potential .
The test consists of a topical exposure of the neat test item to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl-tetrazoliumbromide], in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison with untreated negative controls is used to predict skin irritation potential (see OECD TG 439) and is used for the purpose of classification as irritating or non-irritating according to chemicals law (EU CLP, UN GHS). The test chemical is considered to be irritant to skin in accordance with UN GHS and EU CLP Category 2 if the tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiSkin™ Kit Components Needed for the Assay
EpiSkin™ Kit Lot No.: 17-EKIN-022
1 Sealed 12-well plate; Contains 12 inserts with EpiSkin™ tissues on agarose
1 12-well plate; For MTT viability assay
1 bottle; Assay Medium; Basic medium for use in MTT assays
1 bottle; EpiSkin™ Maintenance Medium; Basic medium for incubations
MTT-Solution
The MTT-solution was prepared freshly on day of use with assay medium (concentration: 0.3 mg/mL).
Cell Culture
EpiSkin™ kits are purchased from SkinEthic Laboratories (69007 Lyon, France). The EpiSkin™ tissue consists of NHEK, which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiSkin™ tissues (surface 0.38 cm²) are cultured on specially prepared cell culture inserts.
EpiSkin™ tissues were shipped at ambient temperature on medium-supplemented agarose gels in a 12-well plate and reached Envigo CRS GmbH on 30 May 2017. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 µL
NEGATIVE CONTROL
- Amount(s) applied: 10 µL
POSITIVE CONTROL
- Amount(s) applied: 10 µL
TEST ITEM PREPARATION
10 µL (26.3 µL/cm^2) of the undiluted test item were applied to each of the triplicate tissues - Duration of treatment / exposure:
- 15 minutes
- Number of replicates:
- 3, triplicate tissues were treated with test substance, positive control or negative control.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Relative absorbance
- Run / experiment:
- 15 Minute exposure
- Value:
- 7.1
- Negative controls validity:
- valid
- Remarks:
- Set to 100%
- Positive controls validity:
- valid
- Remarks:
- 5.3
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Results after treatment with MEDOL-10 and the controls
Dose Group |
Absorbance 570nm Well 1 |
Absorbance 570 nm Well 2 |
Mean Absorbance 570nm |
Mean Absorbance 570 nm * |
Mean Absorbance (%) of 3 Tissues |
Relative Absorbance [%] Tissue 1, 2 + 3 ** |
Relative Standard Deviation |
Rel. Absorbance [% of Negative Control]** |
Blank | 0.038 | 0.038 | 0..38 | 0.000 | ||||
Negative Control | 0.945 | 0.905 | 0.925 | 0.887 | 0.880 | 100.8 | 6.6 | 100.0 |
0.983 | 0.960 | 0.972 | 0.934 | 106.2 | ||||
0.872 | 0.840 | 0.856 | 0.818 | 93.0 | ||||
Positive Control | 0.073 | 0.083 | 0.078 | 0.040 | 0.046 | 4.5 | 12.7 | 5.3 |
0.091 | 0.080 | 0.086 | 0.048 | 5.4 | ||||
0.087 | 0.091 | 0.089 | 0.051 | 5.8 | ||||
Test Item | 0.098 | 0.096 | 0.097 | 0.059 | 0.062 | 6.7 | 6.4 | 7.1 |
0.102 | 0.096 | 0.099 | 0.061 | 6.9 | ||||
0.102 | 0.107 | 0.105 | 0.067 | 7.6 |
* Mean of two replicate wells after blank correction
** relative absorbance per tissue [rounded values]:
*** relative absorbance per treatment group [rounded values]:
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did not lead to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 3 hour incubation with MTT-reagent did not show blue colour.
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 7.1% (threshold for irritancy: ≤ 50%), consequently the test item was irritant to skin.
The acceptance criteria were met:
• the mean OD of the three negative control exposed tissues is ≥ 0.6 till ≤ 1.5 (range: 0.856 to 0.972).
• the rel. standard deviations between tissues of the same treatment group was ≤ 18% (range: 6.4 to 12.7%).
• the mean relative tissue viability of the positive control was ≤ 40% (5.3%).
• the acceptance limit of the IC50 of the respective EpiSkin™ lot was between 1.5 and 3.0 mg/mL after 18 hours treatment with SLS (1.7 mg/mL).
• the results for the positive control and negative control (deionized water; data for PBS are in process) are within the historical data (means, rel. standard deviation, and ranges) of Envigo CRS GmbH
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the experimental conditions reported, MEDOL-10 is irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the irritation potential of MEDOL-10 by means of the Human Skin Model Test according to OECD TG 439.
The test item did not reduce MTT (pre-test for direct MTT reduction), and it did not dye water, when mixed with it (pre-test for colour interference). Consequently, additional tests with freeze-killed tissues or viable tissues (without MTT addition) were not necessary.
Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative control (PBS) or the positive control (5% sodium lauryl sulfate) for 15 minutes.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD ≥ 0.6 till ≤ 1.5 thus showing the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control thus ensuring the validity of the test system.
After treatment with the test item the mean relative absorbance value decreased to 7.1%. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential.In conclusion, it can be stated that in this study and under the experimental conditions reported, MEDOL-10 is irritant to skin according to UN GHS and EU CLP regulation.
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