Registration Dossier
Registration Dossier
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EC number: 200-879-2 | CAS number: 75-56-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Dated study; not reported/performed according to basic scientific principles; dated scoring system.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chemical burns of the rabbit cornea.
- Author:
- Carpenter CP and Smyth HF Jr.
- Year:
- 1 946
- Bibliographic source:
- Amer. J. Ophthalmol. 29:1363-1372 .
Materials and methods
- Principles of method if other than guideline:
- Method preceding the OECD guidelines: Rabbits were used in which a pretest was performed to confirm absence of grossly visible abnormalities.
0.005 ml (0.02, 0.1 or 0.5 ml) of undiluted material was applied to the center of cornea while the lids if the cornea are retracted for about one minute.
Scores were noted 18-24 hours later. - GLP compliance:
- no
Test material
- Reference substance name:
- Methyloxirane
- EC Number:
- 200-879-2
- EC Name:
- Methyloxirane
- Cas Number:
- 75-56-9
- Molecular formula:
- C3H6O
- IUPAC Name:
- 2-methyloxirane
- Details on test material:
- no details
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No details
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.005 and 0.02 ml
- Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 18-24 hours
- Number of animals or in vitro replicates:
- not specified: 5 eyes were tested per test substance
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
After 24hours:
Symptoms visible before fluorescein staining Points Maximum
Cornea dull 2
Cornea opaque, less than half of area 4
Cornea opaque, more than half of area 6 6
Keratoconus 6
Iritis, slight corneal congestion 1
Iritis, marked internal congestion 2 2
Symptoms visible after fluorescein staining Points Maximum
(If necrosis is diffuse assign points
corresponding to half observed area)
Necrosis on less than 5% of cornea 1
Necrosis on 5-12% 2
Necrosis on 13-37% 3
Necrosis on 38-62% 4
Necrosis on 63-87% 5
Necrosis on 88-100% 6 6
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- other: injury grade
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Remarks on result:
- other: Injury grade 5 yields a score of over 5.0: meaning that 0.005 ml gives an injury of up to 5
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
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