Registration Dossier
Registration Dossier
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EC number: 270-109-8 | CAS number: 68411-20-1
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: scientifically acceptable and sufficient documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- One male and one female New Zealand white rabbit, 50 mg of the test substance/rabbit was applied into the conjunctival sac of one eye of each rabbit. The observation time was 7 days. Evaluation of effects according to Draize.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Butanal, reaction products with aniline
- EC Number:
- 270-109-8
- EC Name:
- Butanal, reaction products with aniline
- Cas Number:
- 68411-20-1
- IUPAC Name:
- aniline; butanal
- Details on test material:
- Vulkacit 576 = Butanal, reaction products with aniline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals (1 male + 1 female)
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: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Other effects:
- no data
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
One male and one female New Zealand white rabbit, 50 mg of the test substance/rabbit was applied into the conjunctival sac of one eye of each rabbit. The observation time was 7 days. Evaluation erythema and edma according to Draize.
The cornea and iris score was 0 at any time point. The conjunctiva and chemosis score was 0.2 out of 3 and 4, respectively.
Therefore a classification is not justified.
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