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EC number: 247-415-5 | CAS number: 26021-57-8
- 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:
- from 5 May 1994 to 30th August 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24th February 1987
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,4-dihydro-2H-1,4-benzoxazin-6-ol
- EC Number:
- 247-415-5
- EC Name:
- 3,4-dihydro-2H-1,4-benzoxazin-6-ol
- Cas Number:
- 26021-57-8
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 3,4-dihydro-2H-1,4-benzoxazin-6-ol
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Pouzel, France
- Age at study initiation: not specified
- Weight at study initiation: 2.5 +/- 0.1 kg
- Housing: the animals were housed individually in polystyrene cages (35 x 55 x 32 cm) or (48.2 x 58 x 36.5 cm). Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): free access to 112 pelleted diet. Each batch of food was analysed by the supplier
- Water (e.g. ad libitum): drinking water filtered by a F.G. Millipore membrane (0.22 micron) and contained in bottles was provided ad libitum.
- Acclimation period: at least 5 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: 1 June 1994 To: 5 June 1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- A single introduction of 100 mg of the test substance in its original form was placed into the conjunctival sac of the left eye of 3 animals after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The right eye, which remained untreated, served as a control.
The eyes were not rinsed after administration of the test substance. - Observation period (in vivo):
- Date of treatment: 1.6.94 (day 1)
End of the observation period: 4.6.94 or 5.6.94.
The eye were examined approximately 1, 24, 48, 72 hours after administration of the test substance.
When there is persistent ocular irritation after 72h, the observation period is extended to a maximum of 21 days (unti day 22) in order to determine the progress of the lesions and their reversibility of irreversibility. Any change in the behaviour was noted. - Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 5 days
Any other information on results incl. tables
Table 1: Individual ocular examinations and mean score of the values recorded after 24, 48 and 72 hours for each animal
Rabbit number |
Ocular region |
Description of ocular reactions |
Scores |
Mean irritation scores (24, 48, 72h) |
Interpretation |
||||
1h (D1) |
24h (D2) |
48h (D3) |
72h (D4) |
96h (D5) |
|||||
01 |
Conjunctivae |
Chemosis |
3 |
3 |
1 |
0 |
|
1.3 |
Non-irritant |
Redness |
1 |
2 |
1 |
0 |
|
1.0 |
Non-irritant |
||
Discharge |
0 |
2 |
0 |
0 |
|
0.7 |
|
||
Iris |
|
0 |
0 |
0 |
0 |
|
0.0 |
Non-irritant |
|
Corneal opacity |
Intensity |
0 |
1 |
1 |
0 |
|
0.7 |
Non-irritant |
|
Area |
0 |
2 |
1 |
0 |
|
1.0 |
|
||
Other |
|
none |
none |
none |
none |
|
|
|
|
|
|
|
|||||||
02 |
Conjunctivae |
Chemosis |
2 |
0 |
0 |
0 |
|
0.0 |
Non-irritant |
Redness |
2 |
1 |
0 |
0 |
|
0.3 |
Non-irritant |
||
Discharge |
2 |
0 |
0 |
0 |
|
0.0 |
|
||
Iris |
|
0 |
0 |
0 |
0 |
|
0.0 |
Non-irritant |
|
Corneal opacity |
Intensity |
0 |
1 |
0 |
0 |
|
0.3 |
Non-irritant |
|
Area |
0 |
1 |
0 |
0 |
|
0.3 |
|
||
Other |
|
none |
none |
none |
none |
|
|
|
|
|
|
|
|||||||
03 |
Conjunctivae |
Chemosis |
3 |
1 |
0 |
0 |
0 |
0.3 |
Non-irritant |
Redness |
1 |
2 |
1 |
0 |
0 |
1.0 |
Non-irritant |
||
Discharge |
2 |
2 |
0 |
0 |
0 |
0.7 |
|
||
Iris |
|
0 |
1 |
0 |
0 |
0 |
0.3 |
Non-irritant |
|
Corneal opacity |
Intensity |
0 |
1 |
1 |
1 |
0 |
1.0 |
Non-irritant |
|
Area |
0 |
4 |
2 |
2 |
0 |
2.7 |
|
||
Other |
|
none |
none |
none |
none |
none |
|
|
D = day
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As the mean scores for chemosis, redness, iris, degree of corneal opacity for 2 out of the 3 animals did not reach the criteria values for irritation, under the experimental conditions of the test, Hydroxybenzomorpholine was considered as non-irritant when administered by ocular route in rabbits.
- Executive summary:
A 100 mg sample of neat hydroxybenzomorpholine was instilled into the conjunctival sac of the left eye of 3 male rabbits after gently pulling the lower lid away from the eye ball. The lids were then held together for about one second to avoid any loss of test substance, and the eyes were not rinsed after instillation. The untreated right eye served as control, and ocular reactions were assessed 1, 24, 48, 72 and 96 hours after instillation.
Results
Marked conjunctival reactions (marked chemosis, slight to moderate redness) were observed in all animals one hour after instillation. These conjunctival reactions fully disappeared within 72 hours of instillation. Moderate to marked corneal opacity was observed in all animals on the day after instillation and fully disappeared within 96 hours. Isolated ocular discharge and minimal iris lesions were also observed.Conclusion
Under the conditions of this study, hydroxybenzomorpholine was considered to be moderately irritating to rabbit eyes when tested undiluted.
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