Registration Dossier
Registration Dossier
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EC number: 432-240-0 | CAS number: 12056-51-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 July 1999 to 18 July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 432-240-0
- EC Name:
- -
- Cas Number:
- 12056-51-8
- Molecular formula:
- K2Ti6O13
- IUPAC Name:
- hydrate potassium hydride titanium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 91 mg (equivalent to 0.1 mL) - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- No corneal or iridial effects were noted during the study.
Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation.
All eyes appeared normal at the 72-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the test material was determined to be non-irritating to the eyes.
- Executive summary:
The eye irritation potential of the test material was investigated in a study which was conducted under GLP conditions.
During the study 91 mg of test material was instilled in the eyes of 3 New Zealand White rabbits. Signs of ocular irritation were observed over a period of 72 hours.
No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. All eyes appeared normal at the 72-hour observation.
Under the conditions of the study the test material was determined to be non-irritating to the eyes.
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