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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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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:
2005
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.