Registration Dossier
Registration Dossier
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EC number: 947-787-5 | CAS number: -
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:
- 1 986
- 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
- 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
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
Constituent 1
Constituent 2
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.
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