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EC number: 600-198-4 | CAS number: 101377-47-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- GLP compliance:
- yes
Test material
- Reference substance name:
- bis(4-fluorophenyl)methyl(4H-1,2,4-triazol-4yl-methyl)silane
- EC Number:
- 600-198-4
- Cas Number:
- 101377-47-3
- Molecular formula:
- C16H15N3F2Si
- IUPAC Name:
- bis(4-fluorophenyl)methyl(4H-1,2,4-triazol-4yl-methyl)silane
- Details on test material:
- - Purity: R7623 Technical, solid
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:
- 14 days
- Observation period (in vivo):
- Immediately after instillation, 65 minutes, 24, 48, and 72 hours, 7 and 14 days
- Number of animals or in vitro replicates:
- 3 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: range
- Time point:
- other: 65 minutes to 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score of 3 rabbits
- Irritation parameter:
- iris score
- Basis:
- other: range
- Time point:
- other: 65 minutes to 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean score of 3 rabbits
- Irritation parameter:
- other: conjunctivae score: redness
- Basis:
- other: range
- Time point:
- other: 65 minutes to 72 hours
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean score of 3 rabbits
- Irritation parameter:
- other: conjunctivae score: edema
- Basis:
- other: range
- Time point:
- other: 65 minutes to 72 hours
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean score of 3 rabbits
Any other information on results incl. tables
The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours, and 7 and 14 days following administration. Under the conditions of this study, the test substance was mildly irritating. All ocular irritation reversed by 14 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: mildly irritating
- Remarks:
- Criteria used for interpretation of results: other: Draize score and scheme of Kay and Calandra
- Conclusions:
- Test substance was scored as mildly irritating.
According to the EEC criteria for classification and labeling of dangerous substances, the test substance need not be labeled as an eye irritant. - Executive summary:
The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours, and 7 and 14 days following administration. Under the conditions of this study, the test substance was mildly irritating. All ocular irritation reversed by 14 days.
According to the EEC criteria for classification and labeling of dangerous substances, the test substance need not be classified as an eye irritant.
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