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)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: corn oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
A 50% dilution of SAIB in corn oil was prepared. After warming to 32 degrees C, a 0.1 mL aliquot was instilled into each treated eye.
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
All animals were identified by metal ear tags/cage number. The physical characteristics of the test material, as received, made it unsuitable for dosing in this study. A solution was prepared by dissolving 1.0 gram of the test article in 1.0 mL of corn oil and warming the solution to 32° C. The solution was administered at a volume of 0.1 mL/eye, to each of the six eyes (3 unwashed, 3 washed) utilized in this study. An additional eye (unwashed) was dosed with 0.1 mL of corn oil to serve as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed after administration
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed after administration
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hr
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
washed and unwashed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 hr
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
washed and not washed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
washed and not washed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
washed and not washed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
washed and not washed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
washed and not washed
Irritation parameter:
cornea opacity score
Basis:
animal: 3 washed and not washed eyes eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
3 washed and unwashed eyes
Irritation parameter:
iris score
Basis:
animal: 3 washed and unwashed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Remarks:
No effects
Remarks on result:
no indication of irritation
Remarks:
3 washed and 3 unwashed eyes
Irritation parameter:
chemosis score
Basis:
animal: 3 washed and unwashed
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not measured
Remarks:
other parameters were observed
Remarks on result:
not determinable
Remarks:
Not measured
Irritation parameter:
conjunctivae score
Basis:
animal: 3 washed and unwashed eyes
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: slight
Remarks:
slight effects
Irritant / corrosive response data:
In the control eye, no signs of irritation were observed during the 72-hour observation period. When tested with fluorescein dye 24 hours after dosing, no adnexal or corneal staining was noted.

In unwashed eyes, signs of irritation were limited to moderate erythema of the conjunctivae and nictitating membranes one hour after administration of the test material. At the 24-hour observation period, one of three unwashed eyes appeared normal and slight erythema of the conjunctivae and nictitating membranes were noted in the remaining two eyes. When tested with fluorescein dye 24 hours after dosing, there was no adnexal or corneal staining in the unwashed eyes. By 48 hours, two of three eyes were normal and by 72 hours, all unwashed eyes appeared clinically normal.
Immediate washing was palliative. In washed eyes, signs of irritation were restricted to slight (2/3) to moderate (1/3) erythema of the conjunctivae and nictitating membranes at the one-hour observation period, At 24 hours, all washed eyes appeared normal and no corneal or adnexal staining was observed when the eyes were tested with fluorescein dye.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test article, Sucrose Acetate Isobutyrate (SAIB) produced mild, reversible ocular irritation in rabbits, when instilled as a 50% dilution in corn oil.
Executive summary:

The test article, sucrose acetate isobutyrate (SAIB) was evaluated for its potential to induce ocular irritation in rabbits. The physical characteristics of SAIB, as received, made it unsuitable for dosing in this study. A solution was prepared by dissolving 1.0 gram of the test article in 1.0 mL of corn oil and warming the solution to 32° C. The solution was administered at a volume of 0.1 mL/eye, to each of the six eyes (3 unwashed, 3 washed) utilized in this study. An additional eye (unwashed) was dosed with 0.1 mL of corn oil to serve as a control. In the control eye, no signs of irritation were observed during the 72-hour observation period. When tested with fluorescein dye 24 hours after dosing, no adnexal or corneal staining was noted. The test ardcle was a slight eye irritant when administered as a 50% solution in corn oil. In unwashed eyes, signs of irritation were limited to moderate erythema of the conjunctivae and nictitating membranes one hour after administration of the test material. At the 24-hour observation period, one of three unwashed eyes appeared normal and slight erythema of the conjunctivae and nictitating membranes were noted in the remaining two eyes. When tested with fluorescein dye 24 hours after dosing, there was no adnexal or corneal staining in the unwashed eyes. By 48 hours, two of three eyes were normal and by 72 hours, all unwashed eyes appeared clinically normal. Immediate washing reduced the duration of irritation were restricted to slight erythema of the conjunctivae and nictitating membranes at the one-hour observation period. At 24 hours, all washed eyes appeared normal and no corneal or adnexal staining was observed when the eyes were tested with fluorescein dye.