Registration Dossier
Registration Dossier
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EC number: 223-445-4 | CAS number: 3896-11-5
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US FDA, Federal Register 191.12, 17 September 1964
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (Computing of draize scores for the evaluation of conjunctivae effects combines redness, swelling and discharge to give one conjunctivae score, - lacking detailed information on test animals and test material).
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
Test material
- Reference substance name:
- Bumetrizole
- EC Number:
- 223-445-4
- EC Name:
- Bumetrizole
- Cas Number:
- 3896-11-5
- Molecular formula:
- C17 H18 Cl N3 O
- IUPAC Name:
- 2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TK 10048
- Physical state: solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Information on strain: Albino rabbits
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 40 mg
- Duration of treatment / exposure:
- single application, eyes are not washed after instillation
- Observation period (in vivo):
- 72 hours
- grading of ocular reactlon is performed 24, 48 and 72 hours after instillation - Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Scored according to the Draize system
TOOL USED TO ASSESS SCORE: fluorescein (applied after the 24 hour observation)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 5 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: conjunctivae score in this study = redness + chemosis + discharge
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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