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EC number: 231-810-4 | CAS number: 7747-35-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit interpretation of study results
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The eye irritation test was performed using 9 rabbits. The eye irritation test was performed using 9 rabbits, determined to be free of eye defects and irritation. A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The eyelids were held closed for 1-2 seconds. The left eye served as the untreated control. The eyes were examined at 24, 48, and 72 hours post-treatment.
- GLP compliance:
- no
Test material
- Reference substance name:
- 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole
- EC Number:
- 231-810-4
- EC Name:
- 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole
- Cas Number:
- 7747-35-5
- Molecular formula:
- C7H13NO2
- IUPAC Name:
- 7a-ethyl-tetrahydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole
- Details on test material:
- - Name of test material (as cited in study report): P-1601 (Oxazolidine E, BIOBANTMCS-1246 Antimicrobial)
- Physical state: Light yellow colored liquid
- Analytical purity: 94.52%
- Lot/batch No.: M4590
- Stability under test conditions: Not reported assumed to be stable under normal storage conditions
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 3.0 ± 0.5 kg
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS: Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The left eye served as the untreated control.
- Duration of treatment / exposure:
- The eyelids were held closed for 1-2 seconds. The eyes of the first six rabbits were not treated further after the instillation of the test material, but the eyes of the three remaining rabbits were irrigated with 50mL of lukewarm tap water after a 20-30 second exposure to the test material.
- Observation period (in vivo):
- 24, 48, and 72 hours post-treatment and on the 7th day.
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- The eye irritation test was performed using 9 rabbits, determined to be free of eye defects and irritation. A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The eyelids were held closed for 1-2 seconds. The left eye served as the untreated control.
The eyes of the first six rabbits were not treated further after the instillation of the test material, but the eyes of the three remaining rabbits were irrigated with 50mL of lukewarm tap water after a 20-30 second exposure to the test material.
The eyes were examined at 24, 48, and 72 hours post-treatment. At 72 hours and on the 7th day, a drop of sodium fluorescein (0.24%) was placed on the cornea of each treated eye. The excess fluorescein was flushed with sterile saline, and the eye was examined under a UV light for corneal lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 68
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 44
- Remarks on result:
- other: Washed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 55
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 59
- Remarks on result:
- other: Washed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 55
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 59
- Remarks on result:
- other: Washed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 29
- Remarks on result:
- other: Unwashed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 46
- Remarks on result:
- other: Washed
- Irritant / corrosive response data:
- Cornea:
Time Treatment Opacity Area
24hr Unwashed 1.5 4
24hr Washed 2.7 4
48hr Unwashed 1.8 3.3
48hr Washed 2.0 4
72hr Unwashed 1.8 3.3
72hr Washed 2.0 4
7day Unwashed 1.0 2.0
7day Washed 1.7 2.7
Iris:
Time Treatment Score
24hr Unwashed 1
24hr Washed 1
48hr Unwashed 0.8
48hr Washed 1
72hr Unwashed 0.8
72hr Washed 1
7day Unwashed 0.7
7day Washed 1
Conjunctiva:
Time Treatment Discharge
24hr Unwashed 1
24hr Washed 1
48hr Unwashed 0.8
48hr Washed 1
72hr Unwashed 0.8
72hr Washed 1
7day Unwashed 0.7
7day Washed 0.7
Redness:
Time Treatment Redness
24hr Unwashed 1.7
24hr Washed 1.7
48hr Unwashed 1.8
48hr Washed 3.0
72hr Unwashed 1.8
72hr Washed 3.0
7day Unwashed 0.8
7day Washed 1.3
Chemosis:
Time Treatment Chemosis
24hr Unwashed 1.3
24hr Washed 2.3
48hr Unwashed 1.8
48hr Washed 3.0
72hr Unwashed 1.8
72hr Washed 3.0
7day Unwashed 1.5
7day Washed 1.7 - Other effects:
- On the 7th day, the irritation was still present in 3/6 unwashed and 2/3 washed eyes.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the eye irritation scores, the material was considered to be an eye irritant.
- Executive summary:
The eye irritation test was performed using 9 rabbits, determined to be free of eye defects and irritation. A 0.1mL aliquot of test material was instilled into the lower conjunctival sac of the right eye. The eyelids were held closed for 1-2 seconds. The left eye served as the untreated control.
The eyes of the first six rabbits were not treated further after the instillation of the test material, but the eyes of the three remaining rabbits were irrigated with 50mL of lukewarm tap water after a 20-30 second exposure to the test material.
The eyes were examined at 24, 48, and 72 hours post-treatment. At 72 hours and on the 7thday, a drop of sodium fluorescein (0.24%) was placed on the cornea of each treated eye. The excess fluorescein was flushed with sterile saline, and the eye was examined under a UV light for corneal lesionsWithin the first 24 hours, the test material had produced irritation to the cornea, iris, and conjunctiva of washed and unwashed eyes. The severity of the irritation persisted up to 72 hours in 5/6 unwashed and 3/3 washed eyes. On the 7th day, the irritation was still present in 3/6 unwashed and 2/3 washed eyes.
Based on the eye irritation scores, the material was considered to be an eye irritant.
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