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Signatures Summary Study Identification Materials Introduction Equipment and Reagents Experimental Results Conclusion Technical Report CH – 691/2016 CONTENTS page 2 32 4 5 6 6 7 12 16 SIGNATURES Study Director GLP Microbiology _____________________ _ Silvia Colombo _______________ Date page 2 of 16
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Technical Report CH – 691/2016 SUMMARY ChemService S.r.l. Controlli e Ricerche performed a study to evaluate the antimicrobial activity of two formulation of Stalosan F dry disinfectant against Salmonella thyphimurium , according to the protocol supplied by the sponsor. For this purpose the microbial strain Salmonella thyphimurium ATCC 14028 was exposed to the test substance at the following conditions: - Final concentration: neat (0.310g/carrier) - Contact times: 30 minutes – 8 hours – 24 hours - Temoperature (20-25 °C) After sterilization, 2x2 cm paper squares were contaminated with the inoculum od Salmonella thyphimurium and were then placed in sterile petri dishes (three carriers each plate). One set of square were treated with the test item and one set were left untreated as control. At different exposure times three paper square exposed to the test item were removed from each plate and assayed for the microbial viable count. The same procedure was performed for the untreated control. After incubation time of (37 ± 1) °C for 48 hours, the resuts are expressed as Percent Kill (% Kill) and Percent Inhibition (% Inhibition); they are reported in the following table- Exposure time 30 minutes 8 hours 24 hours Stalosan F including copper 2931036-001 Average Average % Kill % Inhibition 99.9840% 99.9822% 99.9913% 99.9836% > 99,9985% > 99,9971% Stalosan F excluding copper 2931036-002 Average Average % Kill % Inhibition 99.9570% 99.9522% 99.9820% 99.9660% > 99,9985% > 99,9971% On the basis of the obtained results, in compliance with the assay validity criteria, the test item Stalosan F including copper causes a reduction > 99% calculated versus the time zero against Salmonella thyphimurium ATCC 14028, after 30 minutes of contact. At 8 hours and 24 hours of contact, Stalosan F including copper causes a reduction > 99.9% calculated versus the time zero, against Salmonella thyphimurium ATCC 14028. The test item Stalosan F including copper causes a inibition > 90% at each contact time tested. On the basis of the obtained results, in compliance with the assay validity criteria, the test item Stalosan F excluding copper causes a reduction > 99% calculated versus the time zero against Salmonella thyphimurium ATCC 14028, after 30 minutes of contact. At 8 hours and 24 hours of contact, Stalosan F exluding copper causes a reduction > 99.9% calculated versus the time zero, against Salmonella thyphimurium ATCC 14028. The test item Stalosan F excluding copper causes a inhibition > 90% at each contact time tested. page 3 of 16
