Registration Dossier
Registration Dossier
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EC number: 444-850-4 | CAS number: 1235390-87-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No deviation from OECD-405 guideline, GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP Certificate as an annexe in the study report.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- yes
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1h, 24h, 48h and 72h; + day 4 and day 21 for reversibility
- Number of animals or in vitro replicates:
- 3 per group
- Details on study design:
- 0,1 ml instilled in one eye of each rabbit, after being heated at 80°C, the other eye serving as control.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- chemosis + lacrymation + redness + iris + cornea degree of clouding+ cornea extent of opacity
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 5 - <= 43.7
- Max. score:
- 43.7
- Reversibility:
- fully reversible within: 9 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The Appyclean-6505 is irritating for the eyes with a specific concentration limit of 10%.
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