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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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
other: Draize eye test
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
other: Corn oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Undiluted and 50% in corn oil
Observation period (in vivo):
2 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Not specified.
Other effects:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
Glyceryl oleate was found to be minimally irritating in the eyes of rabbits.
Executive summary:

Glyceryl oleate was assessed in 6 rabbits. The test substance, glyceryl oleate, was applied undiluted and 50% in corn oil to the eyes of 6 rabbits, and rabbits were observed for 2 days. Glyceryl oleate was found to be minimally irritating with irritation scores ranging from 0 to 1.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Glyceryl Oleate
Author:
Cosmetic Ingredient Review
Year:
1986
Bibliographic source:
Journal of the American College of Toxicology

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Draize eye test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.

Test system

Vehicle:
other: Corn oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Undiluted and 50% in corn oil
Observation period (in vivo):
2 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Not specified.
Other effects:
Not specified.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Glyceryl oleate was found to be minimally irritating in the eyes of rabbits.
Executive summary:

Glyceryl oleate was assessed in 6 rabbits. The test substance, glyceryl oleate, was applied undiluted and 50% in corn oil to the eyes of 6 rabbits, and rabbits were observed for 2 days. Glyceryl oleate was found to be minimally irritating with irritation scores ranging from 0 to 1.