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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-07-23 - 2014-08-18
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (adopted 30 May 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (adopted Aug 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: - Japan MAFF Testing Guideline of 12 Nosan No. 8147 402.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg
- Test type:
- standard acute method
- Limit test:
- yes
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
- Analytical purity: 98.7 corr. area-%
- Test item No.: 14/0031-2
- Lot/batch No.: DEIMLIB 2014/2
- Expiration date of the lot/batch: Oct 01, 2014
- Homogeneity: The test item was homogeneouos by visual inspection
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks nulliparous and non-pregnant
- Weight at study initiation: males: 226-239 g, females:203-220 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
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 40 cm² clipped skin of the dorsal and dorsolateral parts of the trunk
- % coverage: at least 10% of the body surface
- Type of wrap if used: The test item was covered with an air-permeable dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.82 mL/ kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weight shortly before administration (day 0), weekly thereafter and on the last day of observation. 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: yes
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly therafter and on the last day of observation. Scoring was performed according to Draize.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred within the study period.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination within the study period. No local effects were observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of 5-Methyl-3-vinyloxazolidin after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of 5-Methyl-3-vinyloxazolidin-2-on (undiluted) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.
Neither mortality, nor signs of systemic toxicity or skin effects were observed in the animals.
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
The mean body weight of the male animals increased within the normal range throughout the study period. In the female group three females marginally lost weight and another animal did not gain weight during the first week, but body weights were within the normal range during the second week. In the remaining fifth female the body weight increased within the normal range throughout the study period.
This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. Due to the fact that stagnation of body weight is commonly known for females dermally applied, this stagnation is considered to be unspecific.
No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be
LD50, dermal, rat > 2000 mg/kg bw.
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