Registration Dossier
Registration Dossier
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EC number: 210-412-4 | CAS number: 615-16-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-04-22 to 1986-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-hydroxybenzimidazole
- EC Number:
- 210-412-4
- EC Name:
- 2-hydroxybenzimidazole
- Cas Number:
- 615-16-7
- Molecular formula:
- C7H6N2O
- IUPAC Name:
- 2-hydroxybenzimidazole
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3, the right eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3, the left eye was treated with the test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24h, 48h, 72h
- Score:
- 0
- Irritation parameter:
- other: Fluorescein
- Basis:
- animal: all animals
- Time point:
- other: mean of 24h and 48h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- With reference to the present study the test item is not an eye irritant.
- Executive summary:
With reference to the present study the test item is not an eye irritant.
The judgement is based on the mean (of 24, 48 and 72 h) eye irritation scores tabulated below:
Cornea (animal # 1/2/3): 0.0/0.0/0.0
Iris (animal # 1/2/3): 0.0/0.0/0.0
Conjunctivae redness (animal # 1/2/3): 0.3/0.3/1.3
Conjunctivae chemosis (animal # 1/2/3): 0.0/0.0/0.0
Effects fully reversible within 72 h.
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