Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given - Test substance was tested in a mixture of 3 further substances.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Repeated Insult Patch Test with human volunteers.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance (CAS 26741-53-7) tested in a mixture of 3 further substances.
No further data provided.

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 200
- Sex: 1/3 males and 2/3 females
- Age: 2 - 65
Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
The test materials were applied under occlusion for a series of effective contact periods of two days duration, i.e., Monday to Wednesday and Wednesday to Friday of each week for four weeks. On Mondays, the test materials were applied. On Wednesdays the patches were removed, the contact sites examined and the test materials reapplied for another 48 hour period. On Fridays, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday. A mixture of the group of four materials was applied to a single predesignated contact site which was reserved for this specific group throughout the test. On each application day, 4% aqueous solutions were freshly made. Fifty mL of the solutions of each of the four test materials comprising each group were then mixed together and one mL was pipetted off to saturate a lintine disc, 1.25 inch in diameter. One such disc was placed intimately in contact with the contact site on each participant and covered with a water impermeable sheet of plastic (1.5 in. x 1.5 in.). The plastic was then affixed to the skin with Blenderm tape applied in such a manner so as to seal the edges and maintain the integrity of the micro-climate under the patch. On the second Monday following the removal of the last series of applications, each contact site was challenged with its corresponding composite of test materials. The covers were removed on Wednesday, thereby effecting a challenge contact period of 48 hours duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined 24 and 48 hours later for delayed reactions. At all reading periods, it was found useful to wash the sites in order to remove the dyestuffs obscuring the underlying skin. Satisfactory washing was accomplished with the use of warm water and mild, gentle sponging. In those participants showing visible skin changes typical of irritation resulting from the application of the composite, an additional evaluation was undertaken to determine the particular offending material or materials.

Results and discussion

Results of examinations:
No visible skin changes signifying reaction to injury were observed in any of the subjects during the first, second, fourth, fifth and eighth applications.
Third Application - 2 Day's Duration (Second Week)
Visible skin changes signifying reaction to injury were observed in the following two subjects: # 17 (2+) and # 121 (2+). These showed no contraindication to continuation after change of site.

Sixth Application - 2 Day's Duration (Third Week)
Visible skin changes signifying reaction to injury were observed in subjects 26 who showed a 2+ reaction. There appeared to be no contraindication to continuation after change of site.

Seventh Application - 2 Day's Duration (Fourth Week)
Visible skin changes signifying reaction to injury were observed in the following two subjects: # 51 (2+) and #121 (2+). These showed no contraindication to continuation after change of site.

Challenge Application:
No visible skin changes signifying reaction to injury were observed in any of the subjects.

Applicant's summary and conclusion