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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:
weight of evidence
Study period:
April-August 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with Good Laboratory Practices.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize, J.H. (1965), The appraisal of the safety of chemicals in food, drugs and cosmetics-dermal toxicity, Assoc. of Food and Drug Officials of the United States, Topeka, Kansas, pp.46-59.
Principles of method if other than guideline:
The study following Draize, J.H. (1965), The appraisal of the safety of chemicals in food, drugs and cosmetics-dermal toxicity, Assoc. of Food and Drug Officials of the United States, Topeka, Kansas, pp.46-59.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
yes
Observation period (in vivo):
0; 24; 48; 72 hours
Number of animals or in vitro replicates:
12

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Reversibility:
fully reversible within: 48 hour
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 48 hour
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 48 hour
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 48 hour
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Iodixanol was considered non-irritating
Executive summary:

The potential acute eye irritation of iodixanol was tested in rabbits in the "Draize test". Twelve New Zealand White rabbits (6 males and 6 females) were administered 0.1 ml iodixanol into the conjunctival sac of the right eye. The treated eyes of 6 rabbits (3 males and 3 females) were irrigated with 20 ml lukewarm water 4 seconds after instillation. The eyes of the 6 other rabbits were not irrigated. The left eye of all 12 rabbits was untreated and served as a control. Both eyes of all 12 rabbits were examined visually one day before testing and 24, 48 and 72 hours after iodixanol instillation. In addition, one day prior to, and again 24 hours after iodixanol instillation, both eyes were examined for corneal damage using a Fluoro-I-Strip. The eye irritation was evaluated using the Draize-scoring system. No irritation was observed in the 6 non-irrigated eyes. Among the 6 irrigated eyes, a small area of corneal opacity was detected (with fluorescein staining) in 1 eye after 24 hours, but this was normal again after 48 hours. A similar opacity was noted in a control eye.

It was concluded that iodixanol was essentially non-irritating to rabbit eyes.

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