Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Repeated Insult Patch Test
Principles of method if other than guideline:
The purpose of the study was to determine if the test material is capable of irritating the skin of humans under controlled test conditions; and, if so, to classify the test material as a primary irritant, fatiguing agent, and/or sensitizer on the basis of the visible clinical responses.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 200 subjects.
- Sex: approximately 1/3 were males and 2/3 were females.
- Age: 2 to 65 years.
Clinical history:
No data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusion
- Description of patch: 1.25 inch in diameter.
- Vehicle / solvent: water
- Concentrations: 4%
- Volume applied: 1 mL of the solution of each of the four test materials was pipetted off to saturate a lintine disc. 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.
1 mL of a mixture (1:1:1:1) of the four materials was applied to a single pre-designated contac site, reserved for this specific group, following the same process as the individual components.

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 sitesexamined, and the test materials re-applied 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.

EXAMINATIONS
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.

Results and discussion

Results of examinations:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects during the series of applications or following the challenge application.

Applicant's summary and conclusion

Conclusions:
The composite group of four materials, as tested, was not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent, or sensitizer in any of the 200 subjects.
It may, therefore, be hypothesized that each individual dye comprising the composite group should be innocuous in the normal use of such material as long as the conditions of use do not exceed those under which it was evaluated herein. It may further be hypothesized that any combination of dyes within the composite group should also be innocuous within the same limitations.
Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test subjects.
In this case, since 200 subjects were used, we may predict with 95% certainty that at least 98. 34% of a general population will not be sensitized by this material.
Executive summary:

The substance was tested, together with three substances beloging to the same chemical group, in a group of two hundred (200) individuals aged from 2 to 65 years (ca. 1/3 males and 2/3 females). A 4% aqueous solution was applied under occlusion during a series of a contact period of 48 hours, and following the path: On Mondays materials were applied. On Wednesdays, the patches were removed, the contact sites examined, and the test materials re-applied 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.

After the application period, the skin was examined to determine if the test material could be classified as a primary irritant, fatiguing agent, and/or sensitizer on the basis of the visible clinical responses.

For each material tested, the results were negative, i.e. no significant effects were seen in this study.