Document zzENX6zoLLvMEd0Vo7eq92RGa

Lab Na L 1538 TABLE OF CONTENTS SUMMARY INTRODUCTION MATERIALS METHODS DEVIATIONS RESULTS CONCLUSION RECORD STORAGE PHOTOGRAPH OF THE TEST ARTICLE SBRTC-2015-1052-4 4 5 5 5-7 7 7 8 8 8 Page 3 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, Na 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 Web site: www.sbrtc.com MOM FAX: 00 E-mail: 163.com Lab Ng L 1538 SBRTC-2015-1052-4 Animal Management: Husbandry: Food: Water: Housing: Environmental: Personnel: Selection: Conditions conformed to "Laboratory animal-Requirements of environment and housing facilities"; "ISO 10993-2:2006: Biological evaluation of medical devices Part 2: Animal welfare requirements". Diet was provided from SHANGHAI SLAC LABORATORY ANIMAL CO. LTD Pure water Healthy animals were acclimatized to the laboratory conditions for 5 days before the treatment, and then they were randomized and assigned to groups in cages identified by a card indicating the Identification No of the test article and first treatment date. The room temperature and humidity were monitored daily. The room temperature range was from 21 C to 23 C. The room humidity range was from 57 % to 59 %. The light cycle was controlled using an automatic timer (12 hours light, 12 hours dark). Associates involved were appropriately qualified and trained. Only healthy, unused animals were selected. Experimental Procedure: Prior to dosing, the mice were identified and weighed. Twenty mice were divided into four groups. Each group of five was injected respectively with the fresh extracts of CSO at a dose of 50mUkg and the corresponding reagent control by the intraperitoneal route; each group of five was injected respectively with the fresh extracts of SC and the corresponding reagent control at a dose of 50mUkg by the intravenous route. Mice were observed for adverse reactions immediately after injection, again 4h after injection, and then 24, 48, and 72h, respectively, after injection for symptoms of slight, moderate, or marked toxicity or death. The body weights of all animals and the observations were recorded at 24, 48, and 72 h postinjection. The response to systemic injection assay was given below: Response Normal, no symptoms Description Mouse exhibits no adverse physical symptoms after injection. Slight Mouse exhibits slight but noticeable symptoms of hypokinesia, dyspnea, or abdominal irritation after injection. Moderate Mouse exhibits definite evidence of abdominal irritation, dyspnea, hypokinesia, ptosis, or diarrhea after injection. (Weight usually drops to between 15 and 17g.) Marked Mouse exhibits prostration, cyanosis, tremors, or severe symptoms of abdominal irritation, diarrhea, ptosis, or dyspnea after injection. (Extreme weight loss; weight usually less than 15g.) Page 6 of 8 SHANGHAI BIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, No 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 00f 3 Web site: www.sbrtc.com E-mail: -)163.com Lab N. L 1538 SBRTC-2015-1052-4 CONCLUSION Under the conditions of this study, there was no mortality or evidence of acute systemic toxicity from the extract of the test article. The extract of the test article met the test requirement. RECORD STORAGE All raw data pertaining to this study and a copy of the final report are to be stored m the designated archive files at Shanghai Biomaterials Research & Test Center. PHOTOGRAPH OF THE TEST ARTICLE Non-absorbable Surgical Suture (model: PTFE) No.150642 Page 8 of 8 SHANGHAI SIOMATERIALS RESEARCH & TEST CENTER Add: 201, Building 2, NQ 427 Jumen Road, Shanghai, China Zip Code: 200023 TEL: 0086-21-63034903 FAX: 00 3 Web site: www.sbrtc.com E-mail: -)163.com