Registration Dossier
Registration Dossier
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EC number: 291-443-0 | CAS number: 90411-66-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Version / remarks:
- 27 September 1973
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP guidelines and regulations.
Test material
- Reference substance name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- EC Number:
- 291-443-0
- EC Name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- Cas Number:
- 90411-66-8
- IUPAC Name:
- Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals free from visible ocular defects.
Test system
- Vehicle:
- other: Corn oil
- Controls:
- other: Only one eye in each animal was treated, the untreated eye served as the control.
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The test article is not an ocular irritant to rabbits under the conditions of the test.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test articles was not considered an ocular irritant to rabbits under the conditions of the test.
- Executive summary:
Siz New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 ml the test article in one eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment, and at 4 and 7 days if irritation persisted. The test article was used as a 25% gravimetric corn oil suspension.
This test article is not an ocular irritant to rabbits under the conditions of the test.
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