Registration Dossier
Registration Dossier
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EC number: 947-377-6 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Patch Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Human Patch Test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Repeated Insult Patch Test was performed to confirm that repeated applications of the product under maximized conditions, in healthy subjetcs, does not induce delayed contact allergy reactions. A secondary objective is to determine the irritating potential of the product first after a single application and second after repeated applications.
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Patch test study in human volunteers already available
Test material
- Reference substance name:
- Extract of Boswellia serrata (Burseraceae) obtained from exudate by solvent extraction
- EC Number:
- 947-377-6
- IUPAC Name:
- Extract of Boswellia serrata (Burseraceae) obtained from exudate by solvent extraction
- Details on test material:
- Sample: 71-8-61
Constituent 1
- Specific details on test material used for the study:
- 8% in petrolatum
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male
- Details on test animals and environmental conditions:
- - Number of subjects completing the study: 25 healthy, male volunteers
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 8% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these study conditions, the tes item can be considered non-sensitizing.
- Executive summary:
A maximalisation test was conducted in 25 healthy, male volunteers. Applications of the test material in petrolatum were made under occlusion to the same site on the forearms of all subjects for five alternate-day 48 hour periods. Patch sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a ten day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 1-hourapplications of 10% aqueous SLS under occlusion. Reactions were read on patch removal and 24 hours after patch removal. No effect was observed.
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