Repeated Patch Test (Buehler Method, Modified for Medical Devices) 13.5 ppm Silver Solution Study Number: 1211579-S01 • November 2019

Test Overview

GroupAnimal_IDChallenge_24h_ScoreChallenge_48h_Score
Test Group836000
Test Group836100
Test Group836200
Test Group836300
Test Group836400
Test Group836500
Test Group836600
Test Group836700
Test Group836800
Test Group836900
Test Group837000
Negative Control835400
Negative Control835500
Negative Control835600
Negative Control835700
Negative Control835800
Negative Control835900

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)

GroupAnimal_IDPatch_1Patch_2Patch_3Patch_4Patch_5Patch_6Patch_7Patch_8Patch_9
Test Group8360000000000
Test Group8361000000000
Test Group8362000000000
Test Group8363000000000
Test Group8364000000000
Test Group8365000000000
Test Group8366000000000
Test Group8367000000000
Test Group8368000000000
Test Group8369000000000
Test Group8370000000000
Negative Control8354000000000
Negative Control8355000000000
Negative Control8356000000000
Negative Control8357000000000
Negative Control8358000000000
Negative Control8359000000000

Incidence of irritation during induction: 0%

Results – Challenge Phase

Dermal scores 24 h and 48 h after challenge patch removal

Animal ID24-hour Score48-hour Score
Test Group
836000
836100
836200
836300
836400
836500
836600
836700
836800
836900
837000
Negative Control Group0 (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