Test for in vitro cytoxicity(细胞毒性试验.无纺布生物相容生报告)

Test Report No: SHCPCH190504207·2 Date: Jul 09 2019Page 1 of 3 RAND: 6531919Client name: JunQi Nonwovens Enterprise Co.,Ltd Client address: 204 Huan Shi East Road JiangPu street CongHua GuangzhouSample name: 14gsm white nonwovens fabric Batch No./Date: 20190520 Manufacturer: JunQi Nonwovens Enterprise Co.,Ltd--------------------------------------------------------------------------------------------------------------------------The above information and samples are provided and confirmed by the customer, and SGS is not responsible for confirming the accuracy, appropriateness and/or completeness of the information provided by the customer.SGS job No.: SHCPCH190504207 SGS reference No.: / Date of receipt: May 22 2019 Testing period: May 22 2019 ~ Jun 25 2019Test(s) requested(selected test(s) as requested by applicant), test method(s), test result(s): Please refer to next pageCONCLUSION: Under the conditions of the study, the viability of the 100% extract of the test article was 96.8%，the cytotoxicity of test article was grade 0，which is non-cytotoxic.Unless otherwise stated, the results shown in this test report apply only to the sample(s) as received, and this document cannot be used for publicity without approval of the Company, not be allowed to copy testing report (except for copy of full text) without written approval.Signed for and on behalf ofSGS-CSTC Standards Technical Services (Shanghai) Co.,Ltd………………………Authorized Signature Angela YuTest Report No: SHCPCH190504207·2 Date: Jul 09 2019Page 2 of 3 RAND: 6531919Test typeTests for in vitro cytoxicity*Test method ISO10993-5:2009MATERIALSThe test article was identified and handled as follows: Test article: 14gsm white nonwovens fabric Storage Condition: Room temperature Test article preparation ：According to ISO10993-12 principle for preparing test materials, The extract of the sample wasperformed in DMEM medium containing 10% FBS in 37℃ for 72h, the extraction ratio was 6 cm2/mL. The extracts were used immediately after extraction. cell line ：mouse fibroblast cells L929 Medium ：DMEM medium with 10% FBS,METHODS100μL of singe L929 cell suspension with DMEM was added to 96 wells in density of 1×105. Incubate the cultures at 37℃ in air with 5% carbon dioxide for 24h.Discard the culture medium from the cultures and add 100μL of different concentrations of the extract (25%,50%,75% and 100%) and the same aliquots of the blank, the negtive and positive controls in six replicates. Incubate the cultures in incubator at 37℃, 5% carbon dioxide for 24h.After an incubation period of 24h, the cytotoxic effect was examined with microscope. 50μL of1mg/mL MTT solution was added to each wells and incubated at 37℃ in air with 5% carbon dioxide for 2h. After incubation, remove the MTT solutions and 100μL of isopropanol was added to each well and the microtitre plate was shaked rapidly on a microtitre plate shaker for 20 min. The absorption of each wells were measured at 570nm with microtitre plater reader. Cell viablity of the test sample ， negative control and positive control were calculated.RESULTSCytotoxicity test results of 14gsm white nonwovens fabric were shown in Table 1.1. Cytotoxic effect of the extract of the test sample on the morphology of L929 cells.GroupGrowth state Confluent Monolayer Shape of cellGrade scoreNegitive control Well （+） Normal ，no cell lysis and no reduction of cell growth 0 Liquid extract of the sampleWell（+）Normal ，no cell lysis and no reduction of cell growthTest Report No: SHCPCH190504207·2 Date: Jul 09 2019Page 3 of 3 RAND: 6531919Positive controlGrowth inhibition（-）More than 90%of cells are round or laysed ，cell layers arecompletely distroyed42. Cytotoxic effect of the extract of the test sample on L929 cells. Group ConcentrationCell viability Blank control- 100% the extract of the test article30% 100% 50%94.6% 70% 102.3% 100%96.80% Positive control(ZDEC)100%0.4%Remark: *The test was carried out by external laboratory assessed as competent.Sample Description: Sample in bagIn the territory of the People’s Republic of China, the test report shall only be used for client scientific research, teaching, internal quality control, product research and development, etc… and just for client internal reference.*** End of Report***。