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:
documentation insufficient for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeated Insult Patch Test
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:
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 cf the visible clinical responses.

A group of 200 individuals who qualified were selected from a local population.
All of these individuals volunteered to participate in this evaluation. The criteria for qualifying were:
1. General well-being.
2. Absence of any skin disease which might be confused with skin reactions from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract. (In the case of minors, parental consent was obtained).
Route of administration:
dermal
Details on study design:
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 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.

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. 50 ml of the solutions of each of the four test materials comprising each group were then mixed together and 1 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 inch by 1.5 inch). The plastic was then affixed to the skin with Blenderrn tape applied in such a manner 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.

Composites which elicited reactions during the test were separated into individual components for re-challenge on reacting individuals. Results of these re-challenge applications are appended.
At all reading periods, it was found useful to wash the sites in order to remove the dyestuffs obscuring the underlying skin, Mild, gentle sponging with warm water was found to be satisfactory.

Results and discussion

Results of examinations:
Visible skin changes signifying reaction to injury were observed in 2 out of 200 subjects during the series of application or following the challenge application.
On re-challenge, the component found to be responsible was one of the tested components, other than test item.
Despite the reactions elicited by the composite and/ or the components contained therein, it is the opinion of the investigator that the results must be interpreted as indicative of having potential rather than obligatory irritating capabilities because of the unusual conditions of the test.

Applicant's summary and conclusion

Conclusions:
Non skin-sensitising under tested conditions.
Executive summary:

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 cf the visible clinical responses. A group of 200 individuals who qualified were selected from a local population. 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. 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. Composites which elicited reactions during the test were separated into individual components for re-challenge on reacting individuals.

Visible skin changes signifying reaction to injury were observed in 2 out of 200 subjects during the series of application or following the challenge application. On re-challenge, the component found to be responsible was one of the tested components, other than test item. Despite the reactions elicited by the composite and/ or the components contained therein, it is the opinion of the investigator that the results must be interpreted as indicative of having potential rather than obligatory irritating capabilities because of the unusual conditions of the test.

Conclusion

Non skin-sensitising under tested conditions.