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EC number: 229-114-0 | CAS number: 6413-10-1
- 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:
- 10 July 2013 to 15 July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl 2-methyl-1,3-dioxolane-2-acetate
- EC Number:
- 229-114-0
- EC Name:
- Ethyl 2-methyl-1,3-dioxolane-2-acetate
- Cas Number:
- 6413-10-1
- Molecular formula:
- C8H14O4
- IUPAC Name:
- ethyl 2-(2-methyl-1,3-dioxolan-2-yl)acetate
- Details on test material:
- - Name of test material (as cited in study report): Methyl Dioxolan
- Appearance: Clear colourless liquid
- Storage condition of test material: Room temperature in the dark
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN™
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: collagen type I matrix coated with type IV collagen
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 10 µL of test material was applied to the epidermis surface.
- Duration of treatment / exposure:
- 15 minutes.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 95.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 83
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 103.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - Direct MTT Reduction
The MTT solution containing the test material did not turn blue which indicated that the test material did not directly reduce MTT.
- Test Material, Positive Control Item and Negative Control Item
The individual and mean OD562 values, standard deviations and tissue viabilities for the test material, negative control and positive control are given in Table 1. The mean viabilities and standard deviations of the test material and positive control, relative to the negative control are also given in Table 1.
The relative mean viability of the test material treated tissues was 94.0 % after a 15-minute exposure period and 42 hours post-exposure incubation period.
It was considered unnecessary to perform IL-1α analysis as the results of the MTT test were unequivocal.
Any other information on results incl. tables
Table 1: Mean OD562 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item, and Test Material
Substance |
OD562 of Tissues |
Mean OD562 of Triplicate Tissues |
± SD of OD562 |
Relative Individual Tissue Viability (%) |
Relative Mean Viability (%) |
± SD of Mean Relative Viability (%) |
Negative Control Item |
1.006 |
0.842 |
0.144 |
119.5 |
100* |
17.1 |
0.787 |
93.5 |
|||||
0.734 |
87.2 |
|||||
Positive Control Item |
0.113 |
0.080 |
0.028 |
13.4 |
9.5 |
3.4 |
0.067 |
8.0 |
|||||
0.061 |
7.2 |
|||||
Test material |
0.804 |
0.792 |
0.087 |
95.5 |
94.0 |
10.4 |
0.699 |
83.0 |
|||||
0.872 |
103.6 |
* = The mean viability of the negative control tissue is set at 100 %
SD = Standard Deviation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test the test material was considered to be a non-irritant.
- Executive summary:
A test was carried out to evaluate the skin irritation potential of the test material in vitro, using the EPISKIN™ reconstructed human epidermis model. The study was conducted under GLP conditions and in accordance with the standardised guidelines OECD 439 and EU Method B.46.
The test consisted of a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay is based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt to a blue formazan salt (with the mitochondria of viable cells) in the test material treated tissues relative to the negative controls.
The relative mean viability of the test material treated tissues was 94.0 % after the 15-minute exposure period and 42 hour post-exposure incubation period.
As a result of this, the test material is not considered to be classified as a skin irritant according to EU criteria.
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