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EC number: 257-048-2 | CAS number: 51200-87-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Federal Register, Title 21, Part 191
- Deviations:
- not specified
- Principles of method if other than guideline:
- - Principle of test:
Eye Irritation in Rabbits by introduction to the eye
- Short description of test conditions: 0.1 ml of the test material was introduced topically into a cup formed by retracting the lower eyelid of the right eye only of each of six albino rabbits. After introduction of the test substance (Oxazolidine-A, Lot. No. 575916, 87.4%), the eyelids were held closed for one second. The test animals were then maintained without further treatment and their eyes were examined at 24, 48 and 72 hours after treatment.
- Parameters analysed / observed: Visualization of the treated eyes was accomplished through use of a hand-held slit lamp and spectacle loupes. Because of the severe reactions observed and the consequent risk of exacerbation of the responses, fluorescein sodium solution was not instilled into the eyes to aid the observations. - GLP compliance:
- not specified
Test material
- Reference substance name:
- 4,4-dimethyloxazolidine
- EC Number:
- 257-048-2
- EC Name:
- 4,4-dimethyloxazolidine
- Cas Number:
- 51200-87-4
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 4,4-dimethyl-1,3-oxazolidine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Lot No.of test material:
575916
- Concentration: 87.4% w/w
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other:
- Remarks:
- Albino rabbits
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml of the test material - Duration of treatment / exposure:
- After induction of the test substance, were hold closed for one second.
- Observation period (in vivo):
- The test animals were then maintained without further treatment and their eyes were examined at 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 6 Albino Rabbits
- Details on study design:
- SCORING SYSTEM:
according to the method of Draize as described in the "Illustrated guide for grading eye irritation byhazardous substances" prepared by the U.S. Department of Health Education and Welfare, FDA
TOOL USED TO ASSESS SCORE: hand-slit lamp. Due to the severe reactions no fluorescein was instilled
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- inflamation
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- inflamation
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- inflamation
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- inflamation
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- inflamation
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- inflamation
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- > 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal:
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Remarks:
- Unable to observe the iris and bulbar conjunctivae because of corneal opacity and pronounced inflammation and edema
- Irritant / corrosive response data:
- Initial observation: All animals reacted with apparent pain within a few seconds after aplication of the test material. Excessive lacrymation of the treated eyes.
24-hour observation: Eyelids and palpebral conjunctivae edematous and inflamed; heavy, mucinous discharge. Corneas cloudy (evidence of corneal edema). Unable to observe the iris and bulbar conjunctivae because of corneal opacity and pronounced inflammation and edema.
48-hour observation: Increased severity of conjunctival edema and inflammation. Continued heavy, mucinous discharge
72-hour observation: Puriform discharge from treated eyes of all animals; increased degree of corneal opacity. Increase in edema and inflammation- conjunctivae pendulous; lid eversion in all animals.
No evidence of corneal ulceration at any observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Topical treatment of rabbit eyes with Oxazolidine-A elicited a strong, positive reaction in 100 % (6 of 6 rabbits) of the test animals.
- Executive summary:
The test procedure employed is discussed in The Federal Register, Title 21, Part 191, para. 191.12 amd was conducted as described briefly as follows: 0.1 ml of the test material was introduced topically into a cup formed by retracting the lower eyelid of the right eye only of each of six albino rabbits. After introduction of the test substance (Oxazolidine-A, Lot. No. 575916, 87.4%), the eyelids were held closed for one second. The test animals were then maintained without further treatment and their eyes were exaimned at 24, 48 and 72 hours after treatment.
Visualization of the treated eyes was accomplished through use of a hand-held split lamp and spectacle loupes. Because of the severe reactions observed and the consequent risk of excerbation of the responses, fluorescein sodium solution was not instilled into the eyes to aid the observations.
Initial observation: All animals reacted with apparent pain within a few seconds after aplication of the test material. Excessive lacrymation of the treated eyes.
24-hour observation: Eyelids and palpebral conjunctivae edematous and inflamed; heavy, mucinous discharge. Corneas cloudy (evidence of corneal edema). Unable to observe the iris and bulbar conjunctivae because of corneal opacity and pronounced inflammation and edema.
48-hour observation: Increased severity of conjunctival edema and inflammation. Continued heavy, mucinous discharge
72-hour observation: Puriform discharge from treated eyes of all animals; increased degree of corneal opacity. Increase in edema and inflammation- conjunctivae pendulous; lid eversion in all animals.
No evidence of corneal ulceration at any observation period.
Topical treatment of rabbit eyes with Oxazolidine-A elicited a strong, positive reaction in 100% (6 of 6 rabbits) of the test animals.
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