Triglycerides, C16 and C18 (unsaturated)

Eye irritation

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 for cross-reference:

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 for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

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

Guideline:

other: Draize eye test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid

EC Number:

204-007-1

EC Name:

Oleic acid

Cas Number:

112-80-1

Molecular formula:

C18H34O2

IUPAC Name:

octadec-9-enoic acid

Constituent 2

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

glycerol

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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

1

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

1

Remarks on result:

probability of mild irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 6

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.