title: [The biological safety evaluation of a new developed silicone rubber for inflatable silastic prosthesis].
abstract: OBJECTIVE
  The biological safety of a new developed silicone rubber for inflatable silastic prosthesis (SRISP) was evaluated.
  
  
  METHODS
  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).
  
  
  RESULTS
  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 had no short-term systemic toxicity.
  
  
  CONCLUSIONS
  These results indicated that SRISP met the requirement of biomedical materials and had good bio- security.
authors: Tian
authors: T
authors: Ai
authors: Liang
authors: L
authors: Xing
authors: Liao
authors: L
authors: Jian
authors: Sun
authors: S
authors: Xu
authors: Teng
authors: T
authors: Minhua
authors: Zhang
authors: Z
authors: Li
authors: Chen
authors: C
authors: Yue
mesh_terms: D000818:Animals; D001672:Biocompatible Materials; D003358:Cosmetics; D004129:Dimethylpolysiloxanes; D006168:Guinea Pigs; D019736:Prostheses and Implants; D051381:Rats; D012826:Silicone Elastomers; D018675:Toxicity Tests
chemical_list: D001672:Biocompatible Materials; D003358:Cosmetics; D004129:Dimethylpolysiloxanes; D012826:Silicone Elastomers; C013830:baysilon