Registration Dossier
Registration Dossier
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EC number: 947-760-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May 1988
- 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:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 16, Part 1500.41
- Deviations:
- no
- GLP compliance:
- not specified
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-hexyloxystearate
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 2 animals received none of the test material
2 aniamls received 3.9 ml/kg BW
2 animals recieved 6ml/kg BW
2 animals recieved 9.4ml/kg BW - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and for the 2 weeks subsequent to treatment
- Number of animals:
- 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other:
- Remarks:
- mean results
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material failed to induce sufficient dermal irritation to be considered irritating to skin.
- Executive summary:
In this guideline (CFR 1500.41) study, the test material (unchanged) was administered topically to the intact skin of 8 rabbits. Results were measured at 24 hours using the draize scale. The test material produced a mild irritation which disappeared and failed to induce sufficient dermal irritation to be considered a dermal irritant.
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