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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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:
1971

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

Constituent 1
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
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.