Registration Dossier
Registration Dossier
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EC number: 203-093-8 | CAS number: 103-26-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- N/A
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented, available information is sufficient for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl cinnamate
- EC Number:
- 203-093-8
- EC Name:
- Methyl cinnamate
- Cas Number:
- 103-26-4
- Molecular formula:
- C10H10O2
- IUPAC Name:
- methyl 3-phenylacrylate
- Test material form:
- solid: crystalline
- Details on test material:
- Chemical name: Methyl cinnamate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand white rabbits of both sexes (weighing 2.3 to 3.4 kg.) were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes were used for control
- Amount / concentration applied:
- 3 mg
- Duration of treatment / exposure:
- N/A
- Observation period (in vivo):
- at 1, 4, 24, 48, 72 and 96 hours after dosing
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand albino rabbits, weighing 2.3 to 3.4 kg., were used to evaluate the irritating properties of each individual test material to the eye. Prior to application, the eyes were examined with the aid of fluorescein ophthalmic solution to confirm the absence of lesions in all eyes. One-tenth of one milliliter of the liquid or 3 mg. of the solid test material was instilled in one eye; the other eye, remaining untreated, served as control.
The ocular reactions to test materials were read post-treatment according to the Draize method at 1, 4, 24, 48, 72, and 96 hours and daily thereafter for a total of seven days (weekends excepted). At seven days, all eyes were reexamined with the aid of fluorescein ophthalmic solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Under the conditons of the study, the test material produced conjunctival redness in 1/6 animals at 1, 4 and 24 hours only. 3 mg eye effects, irritant effects, conjunctival redness was observed in 1/6 animals at 1, 4 and 24 hours only, which cleared by 72 hours. No eye irritation was observed in animals receiving any of the test compounds at two hours.
- Other effects:
- No systemic toxic effects occurred in rabbits following the instillation of test substance.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results in this study, the test article methyl cinnamate caused no irritation to rabbits' eyes.
- Executive summary:
This report was published to evaluate the primary irritation of test substance to rabbits' eyes. One-tenth of one milliliter of the liquid or 3 mg. of the solid test material was instilled in one eye; the other eye, remaining untreated, served as control. The ocular reactions to test materials were read post-treatment according to the Draize method at 1, 4, 24, 48, 72, and 96 hours and daily thereafter for a total of seven days (weekends excepted). At seven days, all eyes were reexamined with the aid of fluorescein ophthalmic solution. No systemic toxic effects occurred in rabbits following the instillation of test substance. Under the condiitons of the study, the test material produced conjunctival redness in 1/6 animals at 1,4 and 24 hours only. 3 mg eye effects, irritant effects, conjunctival redness was observed in 1/6 animals at 1, 4 and 24 hours only, which cleared by 72 hours.
Therefore, it is concluded that test substance caused no irritation to rabbit's eyes.
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