Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
NA
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: based on expert group reviews and published data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Modified Draize assay
GLP compliance:
not specified
Type of study:
Draize test
Justification for non-LLNA method:
Study was performed on human volunteers

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphatidylcholines, soya, hydrogenated
EC Number:
306-549-5
EC Name:
Phosphatidylcholines, soya, hydrogenated
Cas Number:
97281-48-6
Molecular formula:
C44H88NO8P
IUPAC Name:
[(2R)-2,3-di(octadecanoyloxy)propyl] 2-(trimethylazaniumyl)ethyl phosphate
Test material form:
other: Estimation based on CAS number
Details on test material:
CAS number 97281-48-6
Specific details on test material used for the study:
15% hydrogenated Leicitinin petrolatum

In vivo test system

Test animals

Species:
other: Human volunteers
Sex:
male/female
Details on test animals and environmental conditions:
120 initial subjects (assay completed with 100 subjects)

Results and discussion

Positive control results:
No information

In vivo (non-LLNA)

Results
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.025 g
No. with + reactions:
1
Total no. in group:
110
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

During the induction phase of the study, two 1+reactions (Erythema throughout the entire patch area) were observed in one subject. At the 48- and 96 h challange readings, one other subject had a 1+ reaction.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No evidence of sensitisation to 15% hydrogenated Leichitin in petrolatum was observed.
Executive summary:

A modified Draize test was performed to determine the sensitization potential of 15% Hydrogenated Lecithin in petrolatum. The test was completed in 110 out of 120 subjects. A total of ten applications were made. Patches were removed 48h after application and test sites were rinsed and evaluated before adding a new patch. 12 days after removal of the last patch, a challenge patch with the same dose used during the induction was applied to a previously untested site. The challange patch was removed after 48 hours and the site evaluated after 48 h and 96 h.

During the induction phase of the study, two 1+reactions (Erythema throughout the entire patch area) were observed in one subject. At the 48- and 96 h challange readings, one other subject had a 1+ reaction. No evidence of sensitisation to 15% hydrogenated Leichitin in petrolatum was observed.