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EC number: 809-852-5 | CAS number: 3395-98-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-05-20 - 2014-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (adopted 17 Dec 2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (adopted 30 May 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted Dec 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3-ethenyl-5-methyl-1,3-oxazolidin-2-one
- EC Number:
- 809-852-5
- Cas Number:
- 3395-98-0
- Molecular formula:
- C6H9NO2
- IUPAC Name:
- 3-ethenyl-5-methyl-1,3-oxazolidin-2-one
- Details on test material:
- - Name of test material (as cited in study report): 5-Methyl-3-vinyloxazolidin-2-on
- Physical state: liquid / colorless to yellowish
- Test item No.: 14/0031-2
- Lot/batch No.: DEIMLIB 2014/2
- Analytical purity: 98.7 corr. area %
- Stability under test conditions: The stability of the test item under storage conditions over the test period was guaranteed by the sponsor.
- Storage condition of test material: Room temperature
- Expire date: October 01, 2014
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 8 - 12 weeks (nulliparous, non-pregnant females)
- Weight at study initiation: 183 - 190 g
- Housing: single housing in Makrolon cage, type III
- Diet: VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 15 g /100 mL
- Amount of vehicle (if gavage): 2 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw
CLASS METHOD (if applicable)
- By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals.
As all animals died, 300 mg/kg bw were administered to 3 female rats in the second step. Because no mortality occurred, 300 mg/kg bw were
administered to another group of 3 female animals in the third step. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- Group 1 (300 mg/kg): 3 females
Group 2 (300 mg/kg) : 3 females
Group 3 (2000 mg/kg undiluted): 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the day of death
or sacrifice moribung starting with study day 1.
Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: Necropsy with gross-pathology examination was performed on the last day of the observation period after
sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations. Necropsy of all animals that died as early as possible after death.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two animals of the 2000 mg/kg test group were found dead at hour 4. One animal of this test group was sacrificed in a moribund state at hour 5.
No mortality occurred in both 300 mg/kg bw test groups. - Clinical signs:
- other: All animals of the 2000 mg/kg bw test group showed poor general state, dyspnea, apathy and abdominal position from hour 0 until hour 3 or hour 4. In two animals atonia was noted from hour 0 until hour 3 and in the third animal from hour 1 until hour 2. I
- Gross pathology:
- The following macroscopic pathologic findings were observed in the animals that died or in the single moribund sacrificed animal in the 2000 mg/kg bw test group (3 females): Yellowish discoloration of the stomach contents, red discoloration of the glandular stomach and red discoloration of the small intestine. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (300 mg/kg bw: 6 females).
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the median lethal dose of 5-Methyl-3-vinyloxazolidin-2-on after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item 5-Methyl-3-vinyloxazolidin-2-on (undiluted or preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females).
The following test substance-related clinical observations were recorded, clinical signs occurred within one day after administration:
2000 mg/kg (single test group):
Mortality in all animals (two animals died, one animal was sacrificed in a moribund state). Poor general state, Dyspnea, Apathy, Atonia and Abdominal position in all animals
Macroscopic pathological findings in the animals that died/ that was sacrificed moribund:
Yellowish discoloration of the stomach contents. Red discoloration of the glandular stomach. Red discoloration of the small intestine.
300 mg/kg (first and second test group):
No mortality occurred. Impaired general state, Piloerectio and Cowering posiotion in all animals. Dyspnea in all animals in the first test group. Abdominal position in one animal in the second test group.
The mean body weight of the animals increased within the normal range throughout the study period.
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
The acute oral LD50 was calculated to be: LD50, oral, rat >300 < 2000 mg/kg bw
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