Registration Dossier
Registration Dossier
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EC number: 700-400-1 | CAS number: 42831-50-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The eye irritation was determined according to the EU Method B.5 and OECD Guideline 405 (Acute Eye Irritation / Corrosion).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-methyl-1,2-oxazole-4-carboxylic acid
- EC Number:
- 700-400-1
- Cas Number:
- 42831-50-5
- Molecular formula:
- C5H5NO3
- IUPAC Name:
- 5-methyl-1,2-oxazole-4-carboxylic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animal weight: 2.5Kg
Age of animal: 3-5 Months
Animal housing: in fully air-conditionned rooms
Ambient temperature: 18+-3°C
Relative humidity: 50+-20%
Lighting time: 12 hours per day
Test system
- Vehicle:
- other: Directly into the conjonctival sac
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100mg was applied into the conjonctival sac of the left eye of one rabbit.
- Duration of treatment / exposure:
- One application of 100mg
- Observation period (in vivo):
- The eye was examined one hour after application of the substance. Due to several irritations the study was terminated one hour after application.
- Number of animals or in vitro replicates:
- One rabbit
- Details on study design:
- Note: About 24 hours before the start of the study the test eye of the animal was examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution.
Only one animal without ocula abnormalities was used for the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1hour
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Irritant / corrosive response data:
- Testing of 5-Methylisoxazole-4-carboxylic acid for primary eye irritation in the rabbit showed, that the substance is severely irritating to eye.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 5-Methylisoxazole-4-carboxylic acid can be classified Irritant on basis of this study.
The substance is severely irritating to eye.
This substance is classified : R41 (Risk of serious damage to eyes) according to reg.67/548/CE..
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