Registration Dossier
Registration Dossier
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EC number: 947-975-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15/1/1996 to 18/1/1996
- 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:
- 1 996
- Report date:
- 1996
Materials and methods
- Principles of method if other than guideline:
- Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of one-tenth of one millilitre (0.1 ml) of the test article in one (1) eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. O
Observations of corneal opacity, irits and conjunctivitis were recorded 24, 48 and 72 hours after treatment, and at four (4) and seven (7) days if irritation persisted. The test article was used as a ten (10) percent dilution in corn oil. - GLP compliance:
- not specified
Test material
- Reference substance name:
- tridecyl 2-hydroxybenzoate
- EC Number:
- 947-975-7
- Molecular formula:
- C20H32O3
- IUPAC Name:
- tridecyl 2-hydroxybenzoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not specified
Test system
- Vehicle:
- other: Corn oil
- Amount / concentration applied:
- 0.1 ml in one eye
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 24/48/72 hours and 4 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of one-tenth of one millilitre (0.1 ml) of the test article in one (1) eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. O
Observations of corneal opacity, irits and conjunctivitis were recorded 24, 48 and 72 hours after treatment, and at four (4) and seven (7) days if irritation persisted. The test article was used as a ten (10) percent dilution in corn oil.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 2.3
- Reversibility:
- not specified
- Remarks on result:
- other: Substance not an irritant
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- other: Substance not an irritant
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- other: Substance not an irritant
Any other information on results incl. tables
| Average Draize Scores | |||||
| Hours | Days | ||||
| Group | 24 | 48 | 72 | 4 | 7 |
| Unwashed | 2.3 | 0 | 0 | - | - |
Applicant's summary and conclusion
- Conclusions:
- This laboratory finds that this test article is practically non-irritating to rabbits, under the conditions of this test. According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.42), this test article is not an ocular irritant.
- Executive summary:
Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of one-tenth of one millilitre (0.1 ml) of the test article in one (1) eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours. O
Observations of corneal opacity, irits and conjunctivitis were recorded 24, 48 and 72 hours after treatment, and at four (4) and seven (7) days if irritation persisted. The test article was used as a ten (10) percent dilution in corn oil.
Average Draize Scores Hours Days Group 24 48 72 4 7 Unwashed 2.3 0 0 - - Conclusion
This laboratory finds that this test article is practically non-irritating to rabbits, under the conditions of this test. According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.42), this test article is not an ocular irritant.
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