Registration Dossier
Registration Dossier
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EC number: 306-549-5 | CAS number: 97281-48-6
Endpoint summary
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
- 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
- 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.
Reference
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.
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
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