Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
lack of details

Data source

Reference
Reference Type:
publication
Title:
HUMAN PATCH TEST OF 19 SUBJECTS WITH NOMEX E-23 WITH 3.7% DMAC, WITH COVER LETTER DATED 9/29/95 (SANITIZED)
Author:
DuPont Specialty Chemicals, Wilmington
Year:
1995
Bibliographic source:
TSCA8(d), OTS0558317

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
no details
Specific details on test material used for the study:
Test material with 3.7% DMAC

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
13 men and 6 women
Route of administration:
dermal
Details on study design:
Fiber tufts of the test material (with 3.7% DMAC) covering approximately one square inch were applied to the arms of 13 men and to the arms or legs of 6 women and held in place with adhesive tape for six days. After a two-week rest period new patches were applied for two days as a challenge test for skin sensitization. Skin under the patches wwa sexamined at two and six days after the initial application and on removal of the challenge patch.

Results and discussion

Results of examinations:
2-Day Observation: No reactions.

6-Day Observation:
Subject A** - Slight erythema with diffuse rash. One hour later - no reactions, rash persisted. At 24 hours - few small papules.
Subject B - Few small papules.

2-Day (Challenge) Observation: No reactions.

**Subject bad perspired profusely under patch. At one hour, entire area coverad by adhesive appeared dry and scaly.

Applicant's summary and conclusion