Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
LD50 oral: >300 - < 2000 mg/kg
LD50 dermal: > 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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 - 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. - 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).
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423; BASF SE 2014), doses of 2000 and 300 mg/kg bw of 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 >300 < 2000 mg/kg bw.
In an acute dermal toxicity study (Limit Test; BASF SE 2014), 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. No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw.
Justification for classification or non-classification
5 -Methyl-3 -vinyl-1,3 -oxazolidin-2 -one is harmful after oral administration (cat. 4, H302) according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.