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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Type of sensitisation studied:
skin
Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Human clinical Maximization test
Principles of method if other than guideline:
Skin sensitisation study (Maximization HRIPT) in human volunteers
GLP compliance:
not specified

Test material

Constituent 1

Method

Type of population:
general
Ethical approval:
not specified
Remarks:
informed consent likely obtained
Subjects:
32 healthy male volunteers
Route of administration:
dermal
Details on study design:
Test sites of both forearms of the subjects were pretreated with a 5% aqueous sodium laural sufate (SLS) solution, under occlusive bandage, for 24 hours preceded the application of test substance. The test material (20% in petrolatum) was applied under occlusion to the same site of each subject, remaining in place 48-hour and appplication repeated at 2-day intervals for a total of 5 inductions. At the end of the 10-14 day rest period (non-treatment) period, new challenge sites (under occlusion) were treated with test substance. Prior to challenge, on the left forearm, the sites were retreated with SLS for 30 minutes preceeding application of the test substance; on the right forearm, no pretreatment with SLS took place. A fifth site (patch with petrolatum vehicle) served as a vehicle control.

Results and discussion

Results of examinations:
No significantly irritating or allergic reactions were observed.

Applicant's summary and conclusion

Conclusions:
In a clinical Maximization HRIP test in 32 human volunteers, the test substance was applied under occlusion to SLS-treated skin, over 5 48-hour induction periods. New skin sites were challenged (with and without SLS). No skin irritation or sensitisation was reported.