Repeated Patch Test (Buehler Method, Modified for Medical Devices)
13.5 ppm Silver Solution
Study Number: 1211579-S01 • November 2019
Test Overview
Group | Animal_ID | Challenge_24h_Score | Challenge_48h_Score |
|---|---|---|---|
Test Group | 8360 | 0 | 0 |
Test Group | 8361 | 0 | 0 |
Test Group | 8362 | 0 | 0 |
Test Group | 8363 | 0 | 0 |
Test Group | 8364 | 0 | 0 |
Test Group | 8365 | 0 | 0 |
Test Group | 8366 | 0 | 0 |
Test Group | 8367 | 0 | 0 |
Test Group | 8368 | 0 | 0 |
Test Group | 8369 | 0 | 0 |
Test Group | 8370 | 0 | 0 |
Negative Control | 8354 | 0 | 0 |
Negative Control | 8355 | 0 | 0 |
Negative Control | 8356 | 0 | 0 |
Negative Control | 8357 | 0 | 0 |
Negative Control | 8358 | 0 | 0 |
Negative Control | 8359 | 0 | 0 |
Test Design Summary
- Species : Hartley albino guinea pigs (male)**
- Test Group : 11 animals
- Negative Control Group : 6 animals (0.9% saline)
- Induction Phase : 9 topical applications (6 ± 0.5 hours each), 3× per week for 3 weeks
- **Dose per induction/challenge: 0.4 mL neat test article on Hill Top Chamber®
- Rest Period : 14 days
- Challenge Phase : Single topical challenge on naïve site, scored at 24 h and 48 h
Results – Induction Phase
24-hour scores after each patch removal
(No irritation observed at any induction in either group)
Group | Animal_ID | Patch_1 | Patch_2 | Patch_3 | Patch_4 | Patch_5 | Patch_6 | Patch_7 | Patch_8 | Patch_9 |
|---|---|---|---|---|---|---|---|---|---|---|
Test Group | 8360 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8361 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8362 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8363 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8364 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8365 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8366 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8367 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8368 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8369 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Test Group | 8370 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative Control | 8354 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative Control | 8355 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative Control | 8356 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative Control | 8357 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative Control | 8358 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Negative Control | 8359 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Incidence of irritation during induction: 0%
Results – Challenge Phase
Dermal scores 24 h and 48 h after challenge patch removal
Animal ID | 24-hour Score | 48-hour Score |
|---|---|---|
Test Group | — | — |
8360 | 0 | 0 |
8361 | 0 | 0 |
8362 | 0 | 0 |
8363 | 0 | 0 |
8364 | 0 | 0 |
8365 | 0 | 0 |
8366 | 0 | 0 |
8367 | 0 | 0 |
8368 | 0 | 0 |
8369 | 0 | 0 |
8370 | 0 | 0 |
Negative Control Group | 0 (all animals) | 0 (all animals) |
Sensitization Incidence: 0%
Sensitization Severity (mean score): 0.0 (at both 24 h and 48 h)
Conclusion
The test article Ag 181109-103 (13.5 ppm silver) produced no evidence of contact sensitization in the guinea pig Buehler test.
Under the conditions of this GLP study, the material is **non-sensitizing.
Compliance & Quality Assurance
- Conducted in compliance with FDA 21 CFR Part 58 (GLP)
- ISO 10993-10:2010
- AAALAC-accredited facility
- Quality Assurance Unit inspected: Challenge phase (05 Oct 2019) & 31 Oct 2019) and Final Report