Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Report on human maximization studies. Report to RIFM
Author:
Kligman AM
Year:
1978
Bibliographic source:
cited in rifm.org for CAS No. 109-60-4

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A maximization test was carried out with test material in petrolatum on 9 males and 16 female, healthy, volunteers. Application was 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 2.5% sodium lauryl sulfate under occlusion. Following a ten day rest period, a challenge patch was applied to a different site on the opposite upper arm for 48 hours under occlusion. The challenge site was pre-treated for one hour with a 10% aqueous solution of sodium lauryl sulfate. The challenge site was read on removal of the patch and 24 hours thereafter.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
9 male and 16 female, healthy, volunteers
Route of administration:
dermal
Details on study design:
48 hour closed patch test, vehicle was petrolatum

Results and discussion

Results of examinations:
In a concentration of 2 %, propyl acetate caused no local effects and is thus not a skin sensitizer in this test.

Applicant's summary and conclusion

Conclusions:
not sensitising