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EC number: 218-787-6 | CAS number: 2235-00-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1-vinylhexahydro-2H-azepin-2-one
- EC Number:
- 218-787-6
- EC Name:
- 1-vinylhexahydro-2H-azepin-2-one
- Cas Number:
- 2235-00-9
- Molecular formula:
- C8H13NO
- IUPAC Name:
- 1-vinylazepan-2-one
- Test material form:
- other: liquid
- Details on test material:
- Clear liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact. The dose was based on the sample weight as calculated from the specific gravity. The test article was applied to the prepared dermal site, one time, by syringe type applicator on a g/kg basis. The test site was covered with a gauze patch, secured with non-irritating tape and gentle pressure was applied to the gauze to aid the distribution of the test article over the area. The torso was wrapped with plastic which was secured with non-irritating tape. At 24 hours, the patches were removed. The residual test article was gently washed off with distilled water prior to dermal observations.
- Duration of exposure:
- 24 hours
- Doses:
- 1000, 1600, 2000, 2500 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The test sites were scored for dermal irritation at 24 hours post dose and on days 7 and 14 using the numerical Draize scale. Additional signs were described. The animals were observed 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for 14 days for mortality. Body weights were recorded pretest, weekly and at death or termination. All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.
- Statistics:
- The LD 50, 95% Confidence Limits, dose response curve and slope were calculated by the method of
Litchfield, J.T., Jr., & Wilcoxon, F., JPET 96:99, 1949.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 700 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 300 - < 2 200
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 300 - < 2 500
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 700 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 300 - < 2 200
- Mortality:
- 1000 mg/kg bw: 0/5 males, 0/5 females
1600 mg/kg bw: 3/5 males, 3/5 females
2000 mg/kg bw: 3/5 males, 2/5 females
2500 mg/kg bw: 4/5 males, 4/5 females - Clinical signs:
- other: The deaths occurred by day 4 and were preceded by physical signs of diarrhea, lethargy, ptosis, dyspnea, negative righting reflex, ataxia, few feces, yellow nasal discharge, red discharge and soiling of the anogenital area, convulsions and mucoid diarrhea
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The LD50 was determined to be 1700 mg/kg bw (males/females combined)
- Executive summary:
Five healthy male and five healthy female New Zealand Albino rabbits were dosed dermally with the test substance at 1000, 1600, 2000 and 2500 mg/kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded on days 1, 7 and 14. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 hours post dose and once daily for 14 days. All animals were observed twice a day for mortality. Body weights were recorded pretest, weekly and at death or termination in the survivors. All animals were examined for gross pathology. The deaths occurred by day 4 and were preceded by physical signs of diarrhea, lethargy, ptosis, dyspnea, negative righting reflex, ataxia, few feces, yellow nasal discharge, red discharge and soiling of the anogenital area, convulsions and mucoid diarrhea. Necropsy of the dead animals revealed abnormalities of the lungs, liver, spleen, pleural cavity, eyes, treated skin, kidneys, heart and gastrointestinal tract, as well as soiling of the anogenital area, wetness of the nose/mouth area, wetness of the anogenital area and red staining of the anogenital area. Physical signs noted in survivors included lethargy, ptosis, yellow nasal discharge, diarrhea, ataxia, dyspnea, few feces, emaciation, soiling of the anogenital area, red discharge, ocular discharge, red staining of the anogenital and mucoid diarrhea. Body weight changes of survivors were generally normal, although instances of weight loss were noted in survivors of all groups. Necropsy results of survivors revealed abnormalities of the treated skin, gastrointestinal tract, lungs, liver and kidneys. The LD 50's and 95 Confidence Limits are: males · 1700 (1300 · 2200) mg/kg; females · 1800 (1300 · 2500) mg/kg; and males & females combined · 1700 (1300 - 2200) mg/kg.
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