Registration Dossier
Registration Dossier
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EC number: 266-946-3 | CAS number: 67701-28-4 This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 01-001-00.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment)
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
- Principles of method if other than guideline:
- Eye irritation potential of castor oil was evaluated in rabbits after single ocular administration
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- IUPAC Name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- Details on test material:
- - Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- None
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- Reactions were scored 18 to 24 h after instillation
- Number of animals or in vitro replicates:
- Five
- Details on study design:
- SCORING SYSTEM: The individual numerical scores for each eye were added together and then divided by the number of eyes. An ocular injury score of 5.0 represents severe injury, and corresponds to necrosis (covering approximately three-fourths of the corneal surface) that is visible only after staining or a more severe necrosis covering a smaller area.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: ocular injury score
- Basis:
- mean
- Time point:
- other: 18-24 h
- Score:
- 1
- Max. score:
- 20
- Reversibility:
- not specified
- Irritant / corrosive response data:
- An injury grade of 1 (maximum score possible = 20) was reported for castor oil
- Other effects:
- No data
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under test conditions, castor oil was found to be slightly irritating to rabbit eyes.
- Executive summary:
In an ocular irritation study, 0.5 mL of undiluted castor oil was instilled into the eyes of five rabbits. The reactions were scored 18 to 24 h later.
An injury grade of 1 (maximum score possible = 20) was reported for castor oil.
Under the test conditions, castor oil was found to be slightly irritating to rabbit eyes.
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