Registration Dossier
Registration Dossier
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EC number: 604-384-6 | CAS number: 14384-34-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Glp guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,3,4,9-tetrahydro-1H-carbazol-3-ol
- EC Number:
- 604-384-6
- Cas Number:
- 14384-34-0
- Molecular formula:
- C12H13NO
- IUPAC Name:
- 2,3,4,9-tetrahydro-1H-carbazol-3-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye
- Observation period (in vivo):
- 3 days after instillation
- Number of animals or in vitro replicates:
- 3 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Cornea and Iris
- Basis:
- mean
- Time point:
- other: 1 hours to 3 days after instillation
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days after instillation
- Irritation parameter:
- overall irritation score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days after instillation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of the TS into the rabbit eye elicited transient very slight to well definded conjunctival irritation only.
The TS will not require labelling.
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