Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.