Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
15% hydrogenated Leicitinin petrolatum
Species:
other: Human volunteers
Sex:
male/female
Details on test animals and environmental conditions:
120 initial subjects (assay completed with 100 subjects)
Positive control results:
No information
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

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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.

The substance phosphatidylcholin, soya, hydrogenated, should therefore not be classified for skin sensitisation