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Registration Dossier
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EC number: 263-171-2 | CAS number: 61791-39-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 05 September 1990 and 06 September 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- EC Number:
- 263-171-2
- EC Name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Cas Number:
- 61791-39-7
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- 2-{2-[(8Z)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol; 2-{2-[(8Z)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethyl (9Z)-octadec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): EH & S 588
- Lot/batch No.: V0G188
- Other: Lab ID: 90-0156
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2.93 kg (one animal)
- Housing: Each animal was housed in a wire mesh cage.
- Diet: ad libitum; Agway ® ProLab Rabbit Formula (Agway, Inc., Syracuse, NY)
- Water: ad libitum; fresh tap water
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated.
- Humidity (%): Not stated.
- Air changes (per hr): Not stated.
- Photoperiod (hrs dark / hrs light): 12 hour light and dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 1 animal only due to severity of reaction.
- Details on study design:
- SCORING SYSTEM:
Primary eye irritation was evaluated at 1 and 24 hours after dose administration. The cornea, iris and conjunctiva were scored separately according to the Draize system.
TOOL USED TO ASSESS SCORE:
Examination for irritation was accomplished with a pen light. The eyes were then treated with sodium fluorescein and examined with a slit light equiped with a cobalt blue filter.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 57211 Male
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal: 57211 Male
- Time point:
- other: 24 hours
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Fluorescein assessment not possible due to extreme swelling.
- Irritation parameter:
- iris score
- Basis:
- animal: 57211 Male
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 57211 Male
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 57211 Male
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 57211 Male
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: The eye did not appear red but the conjunctiva exhibited severe bleaching.
- Irritation parameter:
- chemosis score
- Basis:
- animal: 57211 Male
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Conjunctiva appeared blistered.
- Irritation parameter:
- chemosis score
- Basis:
- animal: 57211 Male
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Conjunctiva appeared blistered.
- Irritant / corrosive response data:
- Test article instillation caused severe ocular irritation characterised by corneal opacity, iritis and conjunctival irritation with blistering. Twenty four hours after dose administration the treated eye was extremely swollen and the cornea could not be examined.
Due to the severe ocular irritation that was noted, the study was terminated after the 24 hour reading.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Due to the severe ocular irritation that was noted, this study was terminated after the 24 hour reading and as a result can be considered as corrosive.
- Executive summary:
The test material was evaluated for potential primary eye irritation using one New Zealand White rabbit. The rabbit was administered 0.1 mL of the test article to the conjunctival sac. The untreated contralateral eye served as a control. Both eyes were examined and ocular irritation was scored according to the Draize method at 1 and 24 hours after dose administration.
Test article instillation caused severe ocular irritation characterised by corneal opacity, iritis and conjunctival irritation with blistering. Twenty-four hours after dose administration, the treated eye was extremely swollen and the cornea could not be examined. The untreated eye appeared normal during the observation period.
Due to the severe ocular irritation that was noted, this study was terminated after the 24 hour reading.
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