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: Report with some details lacking

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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:
The purpose of the test was to determine the irritation and / or sensitization potential of the test product after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel). The 9 Repeated Insult (occlusive) Patch Test (9 RIPT) was conducted as follows:
The amount of test material applied to each test patch was approximately 0.2 g.
Th. test material was placed onto Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects removed the patch 24 hours after application. Twenty-four hour rest peri-ods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine (9) applications of the test material had been made.
Procedural ly, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction Phase or, at the discretion of the Study Director, if the skin re-sponse warrants a change in site, the patch would be applied to a previously unpatched adjacent site for the next application. If a 2-level reaction (or greater) occurs on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenged with the test material.
After a rest period of 15 to 19 days (no further application of the test material, the chal-lenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
not available

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 55
- Sex: 1 male, rest female
- Age: not confirmed
- Race: no data
- Demographic information: no data
Clinical history:
no data
Controls:
no
Route of administration:
dermal
Details on study design:
The purpose of the test was to determine the irritation and / or sensitization potential of the test product after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel). The 9 Repeated Insult (occlusive) Patch Test (9 RIPT) was conducted as follows:
The amount of test material applied to each test patch was approximately 0.2 g.
Th. test material was placed onto Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects removed the patch 24 hours after application. Twenty-four hour rest peri-ods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine (9) applications of the test material had been made.
Procedural ly, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction Phase or, at the discretion of the Study Director, if the skin re-sponse warrants a change in site, the patch would be applied to a previously unpatched adjacent site for the next application. If a 2-level reaction (or greater) occurs on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenged with the test material.
After a rest period of 15 to 19 days (no further application of the test material, the chal-lenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no evidence of any effect.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: all
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0


Applicant's summary and conclusion

Conclusions:
A total of 55 subject. completed the test; 3 subjects discontinued for personal reasons unrelated to the conduct of the study.
Discussion or Conclusions portions of the study.
Scattered, transient. barely perceptible to mild (1-level) non-specific patch test re-sponses were observed on 3/55 test panelists (subject nos.6, 39, 41) during the induc-tion or challenge phase of the study. Non. of the non-specific response were irritant or allergic in nature.
Under the conditions of a repeated insult occlusive patch test beta Cyclodextrin did not induce irritation or allergic contact dermatitis in human subjects.