Registration Dossier
Registration Dossier
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EC number: 226-730-1 | CAS number: 5459-58-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-06-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Deviations:
- not specified
- Principles of method if other than guideline:
- Schleimhautreizwirkung Testung am Kaninchenauge aus: Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Cyanessigsäurebutylester
- IUPAC Name:
- Cyanessigsäurebutylester
- Test material form:
- other: liquid
- Details on test material:
- no data available
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Examination of the eyes was made after 24, 48 and 72 hours after instillation and after 8 days (8d findings are not included in the evaluation of the irritation index). Observation of the eyes was aided by the use of a ophthalmoscops.
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 6
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 5
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1.6
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 and 48 hours
- Score:
- 3.3
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.8
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 7.3
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 4
- Reversibility:
- fully reversible within: after 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3
- Reversibility:
- fully reversible within: after 72 hours
- Other effects:
- No corneal damage or iridial inflammation was seen throughout the observation period.
Conjunctival reddening and a slight swelling was noticed. Clear colorless eye defluxion was observed.
All reactions had resolved 72 hours after instillation.
Any other information on results incl. tables
Group mean score at 1h: --- Maximum mean score: 17
Group mean score at 24h: 17 Group mean score at 72h > 0
Group mean score at 48h: 12
Group mean score at 72h: 6
Group mean score at 7d: 0
Result: moderate irritant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the rabbit eye.
- Executive summary:
The study was performed 1981, following the Code of Federal Regulations, Title 16, Section 1500.42, before GLP- and OECD-testing guidelines were available and in force and amended in year 1993 (Addendum to Lonza Report No. 0435).
Six New Zealand White strain albino rabbits were chosen in this test.
The test substance was administered unchanged in the conjunctival sac of the right eye.
Examination of the eyes were made after 24, 48 and 72 hours after instillation. No corneal damage or iridial inflammation was seen throughout the observation period. Conjunctival reddening and a slight swelling was noticed. Clear colorless eye defluxion was observed. All reactions had resolved 72 hours after instillation.In conclusion, the test item is not irritating to the rabbit eye.
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