Carcinogenesis, Teratogenesis & Mutagenesis ›› 2015, Vol. 27 ›› Issue (6): 480-483.doi: 10.3969/j.issn.1004-616x.2015.06.016

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Study of positive reference material for cytotoxicity test

FU Bufang1, LIN Hongsai2, WANG Chunren1, FENG Xiaoming1   

  1. 1. National Institutes for Food and Drug Control, Beijing 100050;
    2. Beijing Institute of Medical Device Testing, Beijing 101111, China
  • Received:2015-06-15 Revised:2015-10-20 Online:2015-11-30 Published:2015-11-30

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Abstract: OBJECTIVE: Polyvinyl chloride(PVC) was used as matrix to prepare the positive reference material by adding dibutyl tin maleate. METHODS: Identification and impurity inspection were carried out for the matrix. The positive reference material,PVC film containing organic tin,was prepared by tape casting process. Sample extract was prepared for L929 cell culture medium. The optimal organic tin concentration was determined by cell morphology examination and MTT test. Homogeneity and stability test were performed for the positive reference material. RESULTS: Extract of PVC film containing 0.005% organic tin exhibited significant cytotoxicity in a dose-effect manner. The homogeneity test showed the statisticd F was 1.07 which was less than the threshold value F. PVC film containing 0.005% organic tin exhibited stable positive reactions. Whilst the materials before and after aging test revealed that the tin contentobtained from extraction was uniform(P>0.05). CONCLUSION: Extract of PVC film containing 0.005% organic tin showed appropriate cytotoxicity,PVC film containing organic tin had a good uniformity and stability,so it could suitable as a cytotoxic reference material.

Key words: reference material, cytotoxicity test, polyvinyl chloride, organic tin

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