Registration Dossier

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:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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..