Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-01-03 to 2007-02-09
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 115
- Sex: male and female
- Age: 16 to 78 years old
- Race: No data
- Demographic information: No data
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: occlusive
- Description of patch: 3/4" x 3/4" absorbent pad portion of an adhesive dressing
- Vehicle / solvent: none
- Concentrations: 100%
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction:
Patches were applied three (3) times per week (e.g., Monday, Wednesday, and Friday) for a total of nine (9) applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four hours after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one (1) makeup day was permitted. This day was added to the Induction period. With the exception of the first supervised Induction Patch reading, if any test site exhibited a moderate (2-level) reaction during the Induction Phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2-level) reaction was observed on this new test site. Applications would also be discontinued if marked (3-level) or severe (4-level) reactivity was noted. Rest periods consisted of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal.

Challenge:
Approximately two (2) weeks after the final Induction patch application, a Challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for Induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application. Should an individual have exhibited a response during this test phase, a Rechallenge Patch Test would have been scheduled to confirm the previously recorded reaction.
- Removal of test substance: Participants were instructed to remove all sebsequent Induction patches at home 24 hours after application.

EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
- Statistical analysis: Results were scored numerically according to the grading system.

Results and discussion

Results of examinations:
With one exception, observations remained within normal limits throughout the test interval. It was noted that Subject #19, Panel # 20070002 exhibited a moderate (2) to mild (1) response with dryness and edema twenty-four, seventy-two and ninety-six hours post-challenge application. This reactive subject was requested to retum for follow-up (Rechallenge) investigation to better define the nature and reproducibility of the response. Observations in the Rechallenge for all treated areas remained negative throughout this test interval. Since the originally observed responses were not reproducible, it is the Laboratory's opinion that they were idiosyncratic in nature and can be considered as clinically insignificant. Under the conditions of this study, the test material did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.

Applicant's summary and conclusion