Registration Dossier
Registration Dossier
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EC number: 213-234-5 | CAS number: 931-36-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-ethyl-4-methylimidazole
- EC Number:
- 213-234-5
- EC Name:
- 2-ethyl-4-methylimidazole
- Cas Number:
- 931-36-2
- Molecular formula:
- C6H10N2
- IUPAC Name:
- 2-ethyl-4-methyl-1H-imidazole
- Details on test material:
- - Name of test material (as cited in study report): EMI-2,4 Fluessig
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Weight at study initiation: male, 3.17 kg; females, 2.93 kg
- Housing: singly in a stainless steel cage with wire mesh walk floors (floor area: 40 x 51 cm)
- Diet (e.g. ad libitum): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-43-3 Kaiseraugst, Switserland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Single application to the conjunctival sac of the right eyelid (not washed out)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 male, 1 female
- Details on study design:
- Readings: 1 hr, 24 hr, 48 hr, 72 hr after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: irritation index could not be read due to severe corneal opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Other effects:
- Other effects observed were contracted pupils (1, 24 h), discharge of blood (1, 24, 48 h), detachment of the cornea (1, 24 h), small retractions in the eyelids (24, 48, 72 h), suppuration (48, 72 h).
The study was discontinued after 72 h because of severe irritation.
Applicant's summary and conclusion
- Interpretation of results:
- other: highly irritating
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