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EC number: 810-292-9 | CAS number: 1072-70-4
- 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
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) 640/2012
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-methyl-1,3-oxazolidin-2-one
- EC Number:
- 810-292-9
- Cas Number:
- 1072-70-4
- Molecular formula:
- C4H7NO2
- IUPAC Name:
- 5-methyl-1,3-oxazolidin-2-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 5-methyl oxazolidin-2-one
- Physical state: liquid, colorless, clear
- Analytical purity: 98.0 area-%
- Lot/batch No.: EWALD-00441
Constituent 1
Test animals
- Species:
- other: in vitro
- Strain:
- other: in vitro
Test system
- Type of coverage:
- other: in vitro
- Preparation of test site:
- other: in vitro
- Vehicle:
- other: in vitro
- Duration of treatment / exposure:
- 3 min and 1 hour(s)
- Details on study design:
- TEST SYSTEM
The EpiDerm TM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in viva. The EpiDerm TM tissues (surface 0.6 cm2)
are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm 0) and commercially available as kits (EpiDerm TM 200), containing 24 tissues on shipping agarose.
Skin model: Epi-200
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
TEST PROCEDURE
Corrosion test: Two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator, as a rule) and test group (test material, negative control and positive control; 12 tissues per test) were used. In addition, two killed control tissues per exposure time were treated with the test
substance and NC, respectively, in order to detect direct MTT reduction. Fifty microliter (50 μL) of the undiluted liquid test substance was applied using a pipette. Control tissues were concurrently treated with 50 μL of de-ionized water (NC, NC KC) or with 50 μL of 8 N potassium hydroxide (PC) or test substance (KC). The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment.
Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
- Irritation test: Three tissues were treated with the test substance, the PC and NC, respectively. In addition three killed control tissues were used for the test substance and NC, respectively, in order to detect direct MTT reduction. Thirty microliter (30 μL) of the undiluted liquid test substance was applied using a pipette. A nylon mesh was placed carefully onto the tissue surface afterwards. Control tissues were concurrently treated with 30 μL of sterile PBS (NC, NC KC) or with 30 μL of 5% SDS (PC) or test substance (KC). A nylon mesh was placed carefully onto the tissue surface afterwards.
The tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator.
The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the surface of each tissue was carefully dried with a sterile cotton swab. Subsequently, the tissues were placed into the incubator at 37°C for 24 ± 2 hours. After 24 ± 2 hours the tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period. After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca.
- Vehicle controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Corrosion test
Exposure period: 3 min |
|||||||
Test substance |
|
|
tissue 1 |
tissue 2 |
mean |
SD |
CV [%] |
NC |
viable tissues |
mean OD570 |
2.229 |
2.145 |
2.187 |
0.059 |
|
Viability [% of NC] |
101.9 |
98.1 |
100.0 |
2.7 |
2.7 |
||
KC tissues |
mean OD570 |
0.124 |
0.193 |
0.158 |
0.048 |
|
|
Viability [% of NC] |
5.7 |
8.8 |
7.2 |
2.2 |
30.6 |
||
15/0112-1 |
viable tissues |
mean OD570 |
1.928 |
1.724 |
1.826 |
0.145 |
|
Viability [% of NC] |
88.2 |
78.8 |
83.5 |
6.6 |
7.9 |
||
KC tissues* |
mean OD570KC NC corrected |
0.000 |
0.000 |
0.000 |
0.000 |
|
|
Viability [% of NC] |
0.0 |
0.0 |
0.0 |
0.0 |
|
||
Mean viability of tissues after KC correction [% of NC]: |
83.5 |
||||||
PC |
viable tissues |
mean OD570 |
0.249 |
0.261 |
0.255 |
0.008 |
|
Viability [% of NC] |
11.4 |
11.9 |
11.7 |
0.4 |
3.3 |
Exposure period: 1 h |
|||||||
Test substance |
|
|
tissue 1 |
tissue 2 |
mean |
SD |
CV [%] |
NC |
viable tissues |
mean OD570 |
2.226 |
2.078 |
2.152 |
0.104 |
|
Viability [% of NC] |
103.4 |
96.6 |
100.0 |
4.8 |
4.8 |
||
KC tissues |
mean OD570 |
0.089 |
0.081 |
0.085 |
0.005 |
|
|
Viability [% of NC] |
4.1 |
3.8 |
3.9 |
0.2 |
6.3 |
||
15/0112-1 |
viable tissues |
mean OD570 |
1.836 |
1.778 |
1.807 |
0.041 |
|
Viability [% of NC] |
85.3 |
82.6 |
84.0 |
1.9 |
2.3 |
||
KC tissues* |
mean OD570KC NC corrected |
0.000 |
0.000 |
0.000 |
0.000 |
|
|
Viability [% of NC] |
0.0 |
0.0 |
0.0 |
0.0 |
|
||
Mean viability of tissues after KC correction [% of NC]: |
84.0 |
||||||
PC |
viable tissues |
mean OD570 |
0.132 |
0.132 |
0.132 |
0.000 |
|
Viability [% of NC] |
6.1 |
6.1 |
6.1 |
0.0 |
0.0 |
* Negative values are set to zero for further calculation
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. However, the results of the KC tissues did not indicate an increased MTT reduction. Thus the KC was not used for viability calculation.
Irritation test
|
Exposure period: 1 h |
||||||||
Test substance |
|
|
tissue 1 |
tissue 2 |
tissue 3 |
mean |
SD |
CV [%] |
|
NC |
viable tissues |
mean OD570 |
2.454 |
2.313 |
2.320 |
2.362 |
0.080 |
|
|
Viability [% of NC] |
103.9 |
97.9 |
98.2 |
100.0 |
3.4 |
3.4 |
|||
KC tissues |
mean OD570 |
0.055 |
0.059 |
0.061 |
0.058 |
0.003 |
|
||
Viability [% of NC] |
2.3 |
2.5 |
2.6 |
2.5 |
0.1 |
5.6 |
|||
15/0112-1 |
viable tissues |
mean OD570 |
2.338 |
2.327 |
2.393 |
2.353 |
0.035 |
|
|
Viability [% of NC] |
99.0 |
98.5 |
101.3 |
99.6 |
1.5 |
1.5 |
|||
KC tissues* |
mean OD570KC NC corrected |
0.010 |
0.009 |
0.003 |
0.007 |
0.004 |
|
||
Viability [% of NC] |
0.4 |
0.4 |
0.1 |
0.3 |
0.2 |
51.6 |
|||
Mean viability of tissues after KC correction [% of NC]: |
99.3 |
||||||||
PC |
viable tissues |
mean OD570 |
0.057 |
0.068 |
0.065 |
0.063 |
0.006 |
|
|
Viability [% of NC] |
2.4 |
2.9 |
2.7 |
2.7 |
0.2 |
8.9 |
|||
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. The results of the KC tissues indicate an increased MTT reduction (mean viability 0.3 % of NC). Thus for the test substance the final mean viability is given after KC correction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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