Registration Dossier
Registration Dossier
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EC number: 268-083-8 | CAS number: 68002-70-0 This substance is identified by SDA Substance Name: C16-C22 trialkyl glyceride and SDA Reporting Number: 21-001-00.
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:
- other: Secondary literature source (documentation insufficient for assessment)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Eye irritation potential of fully hydrogenated coconut oil was determined in rabbits after single ocular administration.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd.
- IUPAC Name:
- Glycerides, C8-18 and C18-unsatd.
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd.
- EC Number:
- 266-946-3
- EC Name:
- Glycerides, C8-18 and C18-unsatd.
- IUPAC Name:
- 266-946-3
- Reference substance name:
- 67701-28-4
- Cas Number:
- 67701-28-4
- IUPAC Name:
- 67701-28-4
- Details on test material:
- - Name of test material (as cited in study report): Fully hydrogenated coconut oil (CAS N° 84836-98-6, EC N° 284-283-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18, C18 unsaturated’
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye acted as control
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- Single administration without eye wash
- Observation period (in vivo):
- Until reversal of effects
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- No data
Results and discussion
In vivo
Resultsopen allclose all
- 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
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: Until reversal of effects
- Score:
- ca. 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 d
- Irritant / corrosive response data:
- Mild irritation
- Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- other: mildly irritating
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- Under the test conditions, fully hydrogenated coconut oil was found to be mildly irritating to rabbit eyes.
- Executive summary:
In an ocular irritation test, fully hydrogenated coconut oil was instilled into eyes of six rabbits in a single dose without subsequent eye wash.
Mild irritation (score: 6/110) was observed. The eyes appeared normal by the fourth day.
Under the test conditions, fully hydrogenated coconut oil was found to be mildly irritating to rabbit eyes.
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