Registration Dossier
Registration Dossier
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EC number: 936-795-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate in study report
Test material
- Reference substance name:
- 864970-33-2
- Cas Number:
- 864970-33-2
- IUPAC Name:
- 864970-33-2
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 68 milligrams
- Duration of treatment / exposure:
- Eye closed with test material in the conjunctival sac of the right eye during 1 second.
- Observation period (in vivo):
- 1 hour, 24 hours, 48 hours , 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes at the 24-hour observation and in one treated eye at the 48-hour observation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The organic part of PACTT, 2 Na is not classified as irritant for eyes. As the mineral part of PACTT, 2 Na, Sodium Bromide, is not either classified as irritant for eyes, it can be concluded that the multi-constituent substance has not to be classified as irritant for eyes.
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