Registration Dossier
Registration Dossier
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EC number: 420-680-6 | CAS number: 134127-48-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 420-680-6
- EC Name:
- -
- Cas Number:
- 134127-48-3
- Molecular formula:
- C47 H47 Cl N2 O3 S
- IUPAC Name:
- 2-{2-[2-chloro-3-(2-{1,3,3-trimethyl-1H,2H,3H-benzo[g]indol-2-ylidene}ethylidene)cyclohex-1-en-1-yl]ethenyl}-1,1,3-trimethyl-1H-benzo[e]indol-3-ium 4-methylbenzene-1-sulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: No separate control animals were included. Only one eye was treated per animal and the other eye remaining untreated, serves as reference control.
- Amount / concentration applied:
- 49mg (a volume of approximately 0.1ml)
- Duration of treatment / exposure:
- about one second
- Observation period (in vivo):
- Observations were made:
- mortality: twice daily
- toxicity: at least once daily
- body weight: day of treatment prior to instillation
- irritation: 1, 24, 48 and 72h after instillation. - Number of animals or in vitro replicates:
- 3 of one sex
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Irritation of the conjunctivae was seen as redness, chemosis and discharge.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Treatment with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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