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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:
other: Guideline study. Study was not conducted in conformance to GLP, but study was conducted on the basis of Federal Registry guidelines. 43:37359-60

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal register, August 22, 1978, 43:37359-60
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sucrose, propoxylated
EC Number:
500-029-3
EC Name:
Sucrose, propoxylated
Cas Number:
9049-71-2
Molecular formula:
C12H14O11-(C3H6O)nH8 sum of n: >1 - <16.5 mol PO
IUPAC Name:
Sucrose, propoxylated
Details on test material:
Test substance: Sucrose, propoxylated (Supplier: DOW Texas Division in Freeport, Texas)
Lot TB 04239-350
Composition: Mixture of random polymers from the reaction products of sucrose and propylene oxide and of glycerine and propylene oxide.
Composition and Mol. weight not mentioned in the report however provided by the test matirial supplier for the purpose of the study summary:
70.4% Sucrose+PO and 29.6% Glycerol+PO
Average molecular weight: 720 g/mol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ray Nicols Rabbitry, Lumberton, Texas

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as a control.
Amount / concentration applied:
TEST MATERIAL
1) Group A: 0.1 ml of the undiluted test substance was instilled into the conjunctival sac of the right eye of 6 rabbits
- 2) Group B: 0.1 ml of the undiluted test substance was instilled into the conjunctival sac of the right eye of 3 additional rabbits. Following 30-second exposure period these eyes were washed for 1 minute with tepid, flowing tape water.
Duration of treatment / exposure:
30 sec exposure
Observation period (in vivo):
7 days post-instillation
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed and unwashed groups


SCORING SYSTEM:
Scoring system time points: 1, 2, 3, 4, and 7 days following instillation

TOOL USED TO ASSESS SCORE: penlight

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #1
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #2
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #3
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #4
Time point:
other: 24 hour
Score:
2
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #5
Time point:
other: 24 hour
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #6
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #1
Time point:
other: 48 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #2
Time point:
other: 48 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #3
Time point:
other: 48 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #4
Time point:
other: 48 hour
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #5
Time point:
other: 48 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal #6
Time point:
other: 48 hour
Score:
0
Max. score:
110
Remarks on result:
other: Unwashed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal: 7
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Washed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal: 8
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Washed eyes
Irritation parameter:
other: Primary Irritation Score
Basis:
animal: 9
Time point:
other: 24 hour
Score:
0
Max. score:
110
Remarks on result:
other: Washed eyes
Irritant / corrosive response data:
Group A (unwashed): slight redness of conjunctiva was observed 2/6 rabbits at 24 hours (group average score = 0.67) and 1/6 rabbits at 48 hours (group averaqge score = 0.33). No corneal injury was observed.
Group B (washed): no irritation and injury observed
Other effects:
Upon instillation of test substance rabbits experienced slight to moderate discomfort, characterized by blinking and/or rubbing the eye with a paw. No irritation was observed 3 days post-instillation.

Any other information on results incl. tables

The report references the scoring method as Federal Register, August 22, 1978, 43:37359 -60. A review of this reference states the grading and scoring of irritation is performed in accordance to Draize, J. H. et al. (1965). The maximum individual animal score for corenea, iris, conjunctivae and chemosis is 4, 2, 3, and 4, respectively. The report does not specify the breakdown of the scores. The scores given are out of a possible 110 (sum of all scores obtained for the cornea, iris and conjunctivae including redness, chemosis and discharge).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is slightly irritating to the eye. The findings do not warrant classification.