Registration Dossier
Registration Dossier
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EC number: 268-084-3 | CAS number: 68002-71-1 This substance is identified by SDA Substance Name: C16-C18 trialkyl glyceride and SDA Reporting Number: 19-001-00.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Principles of method if other than guideline:
- A primary ocular irritation study was conducted in rabbits to evaluate eye irritation potential of a formulation containing fully hydrogenated cottonseed oil.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16-18
- EC Number:
- 268-084-3
- EC Name:
- Glycerides, C16-18
- Cas Number:
- 68002-71-1
- Molecular formula:
- C55H98O6
- IUPAC Name:
- Glycerides, C16-18
- Details on test material:
- - Name of test material (as cited in study report): Formulation containing 3.4, 8, 10 or 12.3% fully hydrogenated cottonseed oil (CAS N° 68334-00-9, EC N° 269-804-9); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18 ’
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- other: formulation base
- Controls:
- not specified
- Amount / concentration applied:
- 3.4, 8, 10 or 12.3% fully hydrogenated cottonseed oil
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- Cornea, iris, and conjunctiva were evaluated at Days 1, 2, 3, 4, and 7 after instillation
- Number of animals or in vitro replicates:
- Six
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritant / corrosive response data:
- Mildly irritating
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, 3.4 - 12.3% of the substance was found to be mildly irritating to rabbit eye.
- Executive summary:
A study was conducted to determine the eye irritation potential of 3.4 -12.3 of the constituent 'glycerides, C16-18' (as fully hydrogenated cottonseed oil) in six rabbits. Cornea, iris, and conjunctiva were evaluated at Days 1, 2, 3, 4, and 7 after instillation.
Under the test conditions, the substance was found to be mildly irritating to rabbit eye (CIR, 2001).
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