Registration Dossier
Registration Dossier
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EC number: 247-384-8 | CAS number: 25973-55-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but with restrictions (no data on test substance purity, no GLP)
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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted: March 1987
- Deviations:
- yes
- Remarks:
- (no data on test substance purity)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
- EC Number:
- 247-384-8
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
- Cas Number:
- 25973-55-1
- Molecular formula:
- C22H29N3O
- IUPAC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)phenol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: individually in metal cages, identified with individually numbered ear tags
- Diet (ad libitum): standard rabbit pellet (Nafag No. 814, Gossau, Switzerland)
- Water (ad libitum): fresh
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml (63 mg) - Duration of treatment / exposure:
- single treatment
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to Draize
TOOL USED TO ASSESS SCORE: Slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: Chemosis grade 1 was noted in 2 out of 3 animals after 1 hour. The effect was reversible within 24 h.
Any other information on results incl. tables
Animals gained body weight as expected.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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