Registration Dossier
Registration Dossier
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EC number: 453-200-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: method of Marzulli-Maibach
- Version / remarks:
- test with occlusive patch according to the method of Marzulli-Maibach.
- Principles of method if other than guideline:
- Assessment of sensitizing potential on adult volunteers, under an occlusive patch according to the method of Marzulli-Maibach.
- GLP compliance:
- yes
- Type of study:
- patch test
- Justification for non-LLNA method:
- An assessment of sensitizing potential on adult volunteer under an occlusive patch according to the method of Marzulli-Maibach was available and conclusive. The realization of LLNA method was considered as non necessary.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: whitish scales
In vivo test system
Test animals
- Species:
- other: human
- Details on test animals and environmental conditions:
- 57 adult volunteers
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- pure test item
- Day(s)/duration:
- 3 times a week during 48h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- pure test item
- Day(s)/duration:
- 48h
- Adequacy of challenge:
- other: maximal concentration
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: induction phase
- Group:
- test chemical
- Dose level:
- pure test item
- No. with + reactions:
- 0
- Total no. in group:
- 54
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Challenge phase
- Group:
- test chemical
- Dose level:
- test item diluted at 5%
- No. with + reactions:
- 0
- Total no. in group:
- 54
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The product Omega 6 ceramide can be considered as non sensitizer.
- Executive summary:
Under the conditions of a repeated insult (occlusive) patch test procedure conducted in a panel of 54 subjects, the product Omega 6 ceramide was "dermatologist-tested" and did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects. The product Omega 6 ceramide can be considered as hypoallergenic.
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