Document Detail


A new porous titanium-nickel alloy: part 2. Sensitization, irritation and acute systemic toxicity evaluation.
MedLine Citation:
PMID:  12652028     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Porous titanium-nickel (PTN) represents a new biomaterial with orthopedic applications as a long-term implant. Because of its nickel content, PTN was tested for its potential to stimulate sensitization, irritation, and systemic toxicity reactions after semi-physiological extraction. In order to do so, an in vivo biocompatibility evaluation was performed following three ISO-standardized methods using accepted animal models for immunity testing: the classical skin sensitization assay (Buehler patch test) in guinea pigs, the rabbit intracutaneous test, and the systemic injection test in mice. The Buehler patch test in guinea pigs revealed no significant change in skin reactions such as erythema or swelling between the induction and the challenge period. In the rabbit intracutaneous irritation test, no irritation or sensitization reactions were observed in saline-extracted PTN samples. Negligible to slight irritation was observed at some of the sites involving PTN samples extracted in cottonseed oil, however the resulting primary irritation index was similar to the one elicited by the blank solution itself. Finally, no toxic symptoms were observed with any of the mice injected with porous titanium-nickel extracts during the acute systemic toxicity test. Based on the above results, porous titanium-nickel is considered to be a non-sensitizing, non-irritant, and non-toxic biomaterial for medical applications.
Authors:
Michel Assad; Alexandr Chernyshov; Michel A Leroux; Charles-H Rivard
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Publication Detail:
Type:  Evaluation Studies; Journal Article    
Journal Detail:
Title:  Bio-medical materials and engineering     Volume:  12     ISSN:  0959-2989     ISO Abbreviation:  Biomed Mater Eng     Publication Date:  2002  
Date Detail:
Created Date:  2003-03-24     Completed Date:  2003-09-26     Revised Date:  2003-11-14    
Medline Journal Info:
Nlm Unique ID:  9104021     Medline TA:  Biomed Mater Eng     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  339-46     Citation Subset:  IM    
Affiliation:
Biorthex Inc., R&D - Biomaterials Department, 9001 Boul. L'Acadie, suite 802, Montreal (QC) H4N 3H5, Canada. massad@biorthex.com
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MeSH Terms
Descriptor/Qualifier:
Administration, Cutaneous
Administration, Topical
Animals
Biocompatible Materials / administration & dosage*,  adverse effects*,  chemistry
Body Weight / drug effects
Edema / chemically induced
Erythema / chemically induced
Guinea Pigs
Injections, Intravenous
Materials Testing / methods,  standards
Mice
Nickel / administration & dosage*,  adverse effects*,  chemistry
Porosity
Rabbits
Skin / drug effects*
Titanium / administration & dosage*,  adverse effects*,  chemistry
Chemical
Reg. No./Substance:
0/Biocompatible Materials; 12035-60-8/titanium nickelide; 7440-02-0/Nickel; 7440-32-6/Titanium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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