Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: basic information given

Data source

Reference
Reference Type:
publication
Title:
Effects of Pressure on Contact Dermatitis.
Author:
Gollhausen, R. and Kligman, A.M.
Year:
1985
Bibliographic source:
Am.J.Ind.Med. 8, 323-328

Materials and methods

Principles of method if other than guideline:
Irritant chemicals were tested in paid volunteers in a closed chamber test.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aquaeous solution, saturated

Method

Ethical approval:
not specified
Details on study design:
Groups of five to seven young, adult, white, paid volunteers.
Exposure assessment:
not specified
Details on exposure:
Test agents were applied to the inner forearm using 19-mm-diameter closed chambers that resembled Duhring Chambers (Frosch and Kligman, Contact Dermatitis, 1979 Mar;5(2):73-81) but were made of deformable plastic instead of rigid aluminum. The chambers were designed to ensure nonleakage, complete occlusion, intimacy of contact, and uniform exposure. The chamber was filled with two thicknesses of nonwoven cotton disks (WebrilR), and 0.1 to 0.2 ml of test fluid was instilled onto the cotton disks (enough to wet the pads without spillover). Pressure to the treated skin areas wasapplied by placing a 9-mm-diameter wood bead atop the chamber and then tightly, encircling the forearm with adhesive tape . The bead depresses the top, forcing the wetted cotton pad to press against the skin. The tests were conducted in pairs, one with and one without pressure (the control). Irritants were applied for 1 to 3 days and were read 30 minutes after removal.

Results and discussion

Results:
Aluminium chloride caused moderate confluent redness (grade 2+).

Applicant's summary and conclusion