Registration Dossier

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:
1996
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

Constituent 1
Chemical structure
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

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.