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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Nature of substance: Powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
66 mg (equivalent to 0.1 ml of bulk substance)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
7 days
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 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
Mean score 1
Time point:
24/48/72 h
Score:
1.7
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
Mean score 3
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
72 h
Max. score:
2
Remarks on result:
other: 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:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
Mean score 2
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
Mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Max. score:
1
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 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
Mean score 2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
Mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
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 1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Max. score:
1
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 7 days
Other effects:
Following fluorescein application to the eyes of all three animals at 24 hours, 30% of the total cornea area in animal number 2 was stained indicating epithelial damage. A repeat of fluorescein treatment at 72 hours yielded negative findings. Immediately after fluorescein examination at 24 hours, both eyes of all three animals were rinsed with water. Residual test substance remained in the eye of animal no. 3.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The overall scores at 24, 48 and 72 hours for the three animals were 0, 1.7 and 0.3 for conjunctivae (redness), 0, 0.3 and 0 for chemosis, 0 for all animals for cornea and 0, 0.3 and 0 for iris. A maximum score of 2 was observed at 72 hours for conjunctivae (redness) and a maximum score of 1 was observed at 24 hours for chemosis and iris.
Executive summary:

The test item was analysed for eye irritation effects on New Zealand White rabbits according to EU Annex V guidelines. Three rabbits were exposed to 66 mg of the test item in powder form (corresponding to 0.1 mL of bulk substance). The overall scores at 24, 48 and 72 hours for the three animals were 0, 1.7 and 0.3 for conjunctivae (redness), 0, 0.3 and 0 for chemosis, 0 for all animals for cornea and 0, 0.3 and 0 for iris. A maximum score of 2 was observed at 72 hours for conjunctivae (redness) and a maximum score of 1 was observed at 24 hours for chemosis and iris. Following fluorescein application to the eyes of all three animals at 24 hours, 30% of the total cornea area in animal number 2 was stained indicating epithelial damage. A repeat of fluorescein treatment at 72 hours yielded negative findings. Changes were fully reversible within 7 days. The test item is not classified for eye irritation.

The study is a GLP compliant, guideline experimental study and is acceptable for assessment with restrictions.