Registration Dossier
Registration Dossier
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EC number: 204-881-4 | CAS number: 128-37-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Draize test according to Draize and Kelly (1952)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study with acceptable restrictions; short observation periode (up to 72 h).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
- Principles of method if other than guideline:
- Method: other: Draize test according to Draize and Kelly (1952), Drug Cosmet. Industr. 71, 36 and FDA (1963), Fed. Reg. 28, 119, 5582
- GLP compliance:
- not specified
Test material
- Details on test material:
- other TS: Compound WTR 15 Nonox TBC (corresponding to Vulkanox KB)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
Amount applied: 100 other: mg - Duration of treatment / exposure:
- whole observation period
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- see text field materials and methods
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no ulceration or opacity
- Remarks on result:
- other: no ulceration or opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: fully reversible
- Irritant / corrosive response data:
- see text field results
- Other effects:
- no data
Any other information on results incl. tables
6 of 6 rabbits showed slight conjunctivitis after 24 hours.
Symptoms were completely reversible after 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
- Executive summary:
Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
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