Registration Dossier
Registration Dossier
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EC number: 421-450-8 | CAS number: 154702-15-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Information from migrated NONS file, as per inquiry number 06-2120017060-79-0000, permission to refer granted by ECHA
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- 2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- conjunctivae score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration : 24 hours. Max. value at end of observation period : 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 0
- Remarks on result:
- other: Max. value at end of observation period : 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. value at end of observation period : 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. value at end of observation period : 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect : Changes fully reversible within 1 day.
- Other effects:
- At the application site, slight reversible ocular changes were evident in two out of the three treated rabbits at 1 hour after treatment and lasting up to 24 hours in one animal. No signs were evident 48 hours after the test article application in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test substance when administered by the ocular route to rabbits under the experimental conditions adopted was considered to be not irritating for the eye.
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