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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

According to clinical study (human patch test) the test item was considered as non-sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
8% in petrolatum
Species:
other: human
Sex:
male
Details on test animals and environmental conditions:
- Number of subjects completing the study: 25 healthy, male volunteers
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
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.

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

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-hour applications of 10% aqueous SLS under occlusion. Reactions were read on patch removal and 24 hours after patch removal. No effect was observed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

In a human patch test, the test item was tested at 8% in petrolatum and it was concluded to be non-sensitising. Based on this result, the registered substance is not expected to need to be classified as skin sensitiser.