Registration Dossier
Registration Dossier
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EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Unknown
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment), but used in the Cosmetic Ingredient Review (CIR) assessment report.
- 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:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Eye irritation potential of coconut oil was determined in rabbits after single ocular administration.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd.
- EC Number:
- 266-929-0
- EC Name:
- Fatty acids, C8-18 and C18-unsatd.
- Cas Number:
- 67701-05-7
- IUPAC Name:
- Fatty acids, C8-18 and C18-unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Coconut acid (CAS N° 61788-47-4 corresponding to EC N° 262-978-7 and EC name Fatty acids, coco); under the SDA nomenclature, the name of this substance is ‘Fatty acids, C8-18 and C18-unsatd.’
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:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye acted as control
- Amount / concentration applied:
- Undiluted
- Duration of treatment / exposure:
- Single administration without eye rinse
- Observation period (in vivo):
- Until reversal of effects
- Number of animals or in vitro replicates:
- Six animals
- Details on study design:
- No data
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: Until reversal of effects
- Score:
- 9
- Max. score:
- 110
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- Mild irritant
- Other effects:
- No data
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 conditions of the study, the test substance was found to be mildly irritating to rabbit eyes.
- Executive summary:
In an ocular irritation test, ‘fatty acids, C8 -18 and C18 -unsatd.’ (as coconut acid) was instilled into eyes of six rabbits in a single dose without subsequent eye wash.
Mild irritation (score: 9/110) was observed. The eyes appeared normal by the fourth day.
Under the conditions of the study, the test substance was found to be mildly irritating to rabbit eyes.
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