Evaluation of the skin sensitizing potential of biodegradable magnesium alloys.
Corroding metals made of magnesium alloys represent a new class of degradable implants for musculoskeletal surgery. These implants may be associated with skin sensitizing reactions because of the release of metal ions. This study was conducted to compare the sensitizing potential of four different magnesium alloys (AZ31, AZ91, WE43, and LAE442) to current implant materials such as titanium (TiAl6V4) and a degradable polymer (SR-PLA96). Solutions and solid chips of these materials were prepared and tested in 156 guinea pigs according to the Magnusson-Kligman test. A standard allergen (hydroxy-cinnamon-aldehyde) causing allergic erythema was used as positive control and a standard irritant (sodium-lauryl-sulfate) causing local skin irritation for less than 24 h was used as negative control. All erythema were graded immediately and 24 h after patch removal by three independent observers. Histomorphological analyses were performed on skin biopsies taken 24 h after patch removal. We found that initial erythema in animals treated with solid chips diminished within 24 h and were caused by local skin irritation. Local skin irritation was also determined in erythema remaining for 24 h after patch removal in animals treated with dissolved test materials. No allergenic reactions according to the histomorphological criteria were observed in skin biopsies. We conclude that no skin sensitizing potential were detected for standard materials as well as for all tested magnesium alloys by the used methods.
Witte
Frank
F
Department of Orthopaedic Surgery, Hannover Medical School, Hannover, Germany. f.witte@web.de
Abeln
Inken
I
Switzer
Elinor
E
Kaese
Volker
V
Meyer-Lindenberg
Andrea
A
Windhagen
Henning
H
D020341:Absorbable Implants / Q000009:adverse effects; D000497:Alloys / Q000009:adverse effects / Q000494:pharmacology*; D000818:Animals; D001491:Basophils / Q000166:cytology / Q000187:drug effects; D001706:Biopsy; D002452:Cell Count; D004890:Erythema / Q000139:chemically induced / Q000473:pathology; D006168:Guinea Pigs; D008274:Magnesium / Q000009:adverse effects / Q000494:pharmacology*; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D023422:Skin Irritancy Tests / Q000379:methods*; D012996:Solutions
D000497:Alloys; C586533:Mg-Al-Zn-Mn-Si-Cu alloy; D012996:Solutions; D008274:Magnesium