Registration Dossier
Registration Dossier
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EC number: 224-931-9 | CAS number: 4560-68-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trihexadecyl citrate
- EC Number:
- 224-931-9
- EC Name:
- Trihexadecyl citrate
- Cas Number:
- 4560-68-3
- Molecular formula:
- C55H106O6
- IUPAC Name:
- trihexadecyl citrate
- 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:
- All animals were free from visible ocular defects at the start of the test.
Test system
- Vehicle:
- other: Corn oil
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml 25%
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 ml of 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, 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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test article is not an ocular irritant to rabbits under the conditions of this test.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article was determined not to be an eye irritant to rabbits.
- Executive summary:
In this guideline (EPA OPP 81-4) study the test article was determined not to be an eye irritant to rabbits. Six New Zealand white rabbits were tested with a single 25% suspension in cornoil dose (0.1 ml) in a single eye. The rabbits were observed daily for 72 hours and for up to 7 days for signs of irritation. No corneal opacity, iritis, or conjunctivitis were observed at any observation period.
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