Registration Dossier
Registration Dossier
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EC number: 265-409-0 | CAS number: 65104-06-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vitro study not performed since in vivo study available.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- In vitro study not performed since in vivo study available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- One-tenth milliliter of the test material was placed into the right conjuctival sac of each of two albino rats. After 20 seconds, one treated eye was washed with tap water for one minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris and conjuctivae were made with hand-slit lamp at one and four hours, and at one, two and three days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)
- EC Number:
- 265-409-0
- EC Name:
- Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)
- Cas Number:
- 65104-06-5
- Molecular formula:
- C6H18N2O8Ti
- IUPAC Name:
- Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- 50% solution of test item
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- albino
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 20 sec
- Observation period (in vivo):
- At one, four hours, one, two and three days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- One-tenth milliliter of the undiluted test material was placed into the right conjuctival sac of each of two albino rats.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- Mild redness was observed after 24 and 48 h.
Slight swelling was obseved after 24 h.
Moderate purulent discharge was observed after 24 h.
No ocular effects were observed after 72 h.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Tyzor LA is moderately or mildly irritating to rabbit eyes. There was no involvement of the cornea or iris and eyes were normal within 3 days.
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