The biological safety evaluation of a new developed silicone rubber for inflatable silastic prosthesis

The biological safety of a new developed silicone rubber for inflatable silastic prosthesis (SRISP) was evaluated. Following the GB/T 16886.10-2005 standard, YY/T 0127.13-2009 standard, and GB/T 16886.11- 2011 standard, samples were prepared and tested by animal experiments, such as guinea pig maxim...

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Bibliographic Details
Published inHua xi kou qiang yi xue za zhi Vol. 32; no. 6; p. 556
Main Authors Ai, Tian, Xing, Liang, Jian, Liao, Xu, Sun, Minhua, Teng, Li, Zhang, Yue, Chen
Format Journal Article
LanguageChinese
Published China 01.12.2014
Subjects
Animals
Biocompatible Materials
Cosmetics
Dimethylpolysiloxanes
Guinea Pigs
Prostheses and Implants
Rats
Silicone Elastomers
Toxicity Tests
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Summary:The biological safety of a new developed silicone rubber for inflatable silastic prosthesis (SRISP) was evaluated. Following the GB/T 16886.10-2005 standard, YY/T 0127.13-2009 standard, and GB/T 16886.11- 2011 standard, samples were prepared and tested by animal experiments, such as guinea pig maximization test, oral mucous membrane irritation test, and short-term systemic toxicity test (oral route). No obvious erythema and edema in the guinea pig abdominal skin were observed after 24, 48, and 72 h of stimulating touch, thus indicating that SRISP does not cause potential skin sensitivity. No local response to SRISP was found, and the visual observation and pathological findings of oral mucosa were normal and similar to that of the control group. Therefore, SRISP had no irritation response to oral mucosa. No clinical signs of toxicity were observed in rats, and no significant differences in weight and weight relative growth rate between extract group and blank control group (P > 0.05) were found. Thus, SRISP h
ISSN:1000-1182