Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed using commercial product according to international guidelines and GLPs.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Reference Type:
publication
Title:
Not stated
Author:
Draize, J et al.
Year:
1944
Bibliographic source:
J Pharm Exp Ther 82: 377-390
Reference Type:
publication
Title:
Appraisal of chemicals in foods, drugs and cosmetics, pg 36-45
Author:
Draize J
Year:
1959
Bibliographic source:
Association of Food and Drug Officials of the U.S., Austin, TX
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Separate isolation by test system. Light cycle: 12 hr light, 12 hr dark. Temperature/humidity: maintained at 22°C ± 3°C and 30 to 70% humidity. Housed individually in cages sized in accordance with “Guide for the Care and Use of Laboratory Animals” of the Institute of Laboratory Resources, National Research Council. Waste material removed twice weekly. Cages and feeder sanitized every 2 weeks. Wayne Rabbit Ratiobn, ad libitum, checked daily and added or replaced as needed. Fresh tap water ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal served as its own control.
Amount / concentration applied:
100 mg/eye
Duration of treatment / exposure:
Instilled once in conjunctival sac of one eye of each animal
Observation period (in vivo):
1, 24, 48 and 72 hr after treatment
Number of animals or in vitro replicates:
3M/3F

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
0
Time point:
other: 1 hr
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
0
Time point:
other: 24 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
0
Time point:
other: 48 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
0
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
iris score
Basis:
mean
Remarks:
0
Time point:
other: 1 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
iris score
Basis:
mean
Remarks:
0
Time point:
other: 24 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
iris score
Basis:
mean
Remarks:
0
Time point:
other: 48 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
iris score
Basis:
mean
Remarks:
0
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1.16
Time point:
other: 1 hr
Score:
1 - 2
Max. score:
2
Reversibility:
fully reversible within: 24 to 48 hr
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
0.16
Time point:
other: 24 hr
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible within: 24 hr to 48 hr
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
0.16
Time point:
other: 48 hr
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
0
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
0.33
Time point:
other: 1 hr
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
0
Time point:
other: 24 hr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
0
Time point:
other: 48 hr
Score:
0
Max. score:
0
Reversibility:
other: does not applty
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
0
Time point:
other: 72 hjr
Score:
0
Max. score:
0
Reversibility:
other: does not apply
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article was not an eye irritant.
Executive summary:

The test article (100 mg/eye) was instilled into the right eye of each of six New Zealand White rabbits (3 males and 3 females). Observations were recorded at 1, 24, 48 and 72 hours after treatment and scored according to the method of Draize. One positive ocular score (due to redness of the conjunctiva in one animal) was recorded at the 1 hour observation period. No other positive scores were recorded at the 1, 24, 48 or 72 hour observation periods. All scores were normal at the 72 hour observation period and the study was terminated. The test article was not an eye irritant.