Registration Dossier
Registration Dossier
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EC number: 805-731-6 | CAS number: 198480-21-6
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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
- Cas Number:
- 198480-21-6
- Molecular formula:
- C44 H46 N2 O3
- IUPAC Name:
- 1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- Scoring of irritation effects was performed app. 1, 24, 48, 72 hours after test item application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting tatal by the number of data points. The primay eye irritation score was 0.11 (max 13).
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:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
The instillation of TSE 8 into the eye resulted in mild, early-onsed and transient oculare changes, such as swelling and reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident 48 hours after treatment.
No abnormal findings were observed in the cornea or iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not induce significant or irreversible damage to the rabbit eye. TSE 8 is considered to be not irritating to the rabbit eye.
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