Registration Dossier
Registration Dossier
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EC number: 947-760-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 March 1984- March 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- EC Number:
- 249-793-7
- EC Name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- Cas Number:
- 29710-25-6
- Molecular formula:
- C26H52O3
- IUPAC Name:
- 2-ethylhexyl 12-hydroxyoctadecanoate
- Test material form:
- other: oil
- Details on test material:
- a-ethyl-hexyl-oxystearate
Constituent 1
- Specific details on test material used for the study:
- a-ethyl-hexyl-oxystearate
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1mL to one eye
- Duration of treatment / exposure:
- Eyes remained unwashed for 24 hours
- Observation period (in vivo):
- 24, 48, 72 hours,
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Draize Scores
| group | 24 hours | 48 hours | 72 hours | 4 days | 7 days |
| Unwashed | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating
- Executive summary:
The test item (0.1mL in 10% corn oil) was applied to one eye of each of 6 rabbits.All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded. No adverse effects were recorded accoring to the Draize system. The test item was not irritating to the eye under these conditions.
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