GLP TESTING OF ZEROMOLD PLUS FOR ACINETOBACTER BAUMANNII

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1 Southwest Research Institute Page 1 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 FINAL REPORT STUDY TITLE GLP TESTING OF ZEROMOLD PLUS FOR ACINETOBACTER BAUMANNII SwRI STUDY NUMBER GLP-SP-242, Project # TEST GUIDELINE OCSPP TESTING FACILITY ATS Labs, Inc. (ATS) 1285 Corporate Center Drive, Suite 110 Eagan, MN Tel: Fax: Southwest Research Institute (SwRI ) Microencapsulation and Nanomaterials Department 6220 Culebra Road San Antonio, Texas , USA Tel: , Fax: SPONSOR BIOSENTA Inc Finch Avenue West, Suite 503 Toronto, Ontario, M3J 3H7 Canada, Tel: TEST ORGANISM Acinetobacter baumannii Multi-drug Resistant (MDR) (ATCC #19606) TEST PRODUCT IDENTITY ZeroMold Plus (48536, BI#0018-6, Lot #2) ZeroMold Plus (48540, BI#0020-2, Lot #4) STUDY DATES Date Sample Received at SwRI: 02/17/2014 Date Sample at LCL Shipped to ATS: 11/20/2014 Study Initiation Date (SwRI): 11/18/2014 Experimental Start Date (ATS): 12/1/2014 Final Experimental End Date (ATS): 12/18/2014 Study End Date (SwRI): 1/06/2015

2 Southwest Research Institute Page 2 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS No claim of confidentiality is made for any information contained in this study on the basis of its falling within the scope of FIFRA Section 10(d)(1)(A), (B), or (C). Company: BIOSENTA Inc. Sponsor Representative: Dene Rogers President and CEO BIOSENTA Inc. Tel: (Office) Signature: Date:

3 Southwest Research Institute Page 3 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 GLP COMPLIANCE STATEMENT This study was declared to be compliant with GLP standards, according to 40 CFR 160: U.S. EPA GLP standards. Study Director: XingGuo Cheng, Ph.D. (Date) Senior Research Scientist Southwest Research Institute APPROVED: Joe A. McDonough, Ph.D. (Date) Director, Microencapsulation and Nanomaterials Department Southwest Research Institute END SPONSOR: Signature: Date: Sponsor Representative: Dene Rogers President and CEO BIOSENTA Inc. Tel: (Office)

4 Southwest Research Institute Page 4 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 QUAL ITY ASSUR ANCE UNIT STATEMENT OF COMPL IANCE It is the intent of Southwest Research Institute (SwRI ) that all studies conducted by our facility shall be of the highest quality and meet or exceed the criteria promulgated by the EPA in accordance with 40 CFR 160 FIFRA Good Laboratory Practices to assure the quality and integrity of the data generated. Testing was performed by ATS Labs which was added to the SwRI Approved Supplier List through a physical audit by the Study Director and Quality Assurance Manager. Final Report for GLP Testing of ZeroMold Plus for Acinetobacter baumannii was inspected by the SwRI Division Quality Assurance Unit (QAU) and the findings submitted to the Study Director and Management on the following dates: Submitted to Inspection Type Inspection Date Study Director & Management GLP protocol/training Data review of ATS Final Report Review SwRI s Quality Assurance Unit audited the raw data, all records, any study deviations, and the report. Documentation and verification of these inspections have been archived. The report was found to be an accurate reflection of the study and the data generated. All raw data will be maintained in the Quality System archives. Jo Ann Boyd, Manager Quality Assurance Unit Southwest Research Institute (Date)

5 Southwest Research Institute Page 5 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 Table of Contents Page STUDY TITLE... 1 STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS... 2 GLP COMPLIANCE STATEMENT... 3 QUALITY ASSURANCE UNIT STATEMENT OF COMPLIANCE... 4 I. INTRODUCTION... 6 II. TEST SUBSTANCE... 6 III. STUDY PERSONNEL... 6 IV. EXPERIMENTAL METHODS AND RESULTS... 7 EXPERIMENTAL METHODS...7 RESULTS...7 ACINETOBACTER BAUMANNII MULTI-DRUG RESISTANT (MDR) (ATCC #19606)...7 V. PROCEDURAL MODIFICATIONS/PROTOCOL AMENDMENTS... 9 VI. STUDY CONCLUSIONS... 9 VII. RECORD & SAMPLE RETENTION... 9 VIII. REFERENCES... 9 IX. APPENDIX... 10

6 Southwest Research Institute Page 6 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 I. INTRODUCTION BIOSENTA Inc. is interested in assessing its ZeroMold Plus Product as an intermediate and/or low-level disinfectant that kills pathogenic and potentially pathogenic microorganisms on hard non-porous inanimate surfaces or inanimate objects, when used according to labeling. This project provided testing to perform GLP AOAC Germicidal Spray Testing of ZeroMold Plus for Acinetobacter baumannii. Testing was performed at ATS Labs at the facility address provided on the cover. This lab was previously audited for the Approved Supplier List (ASL) and has completed the qualification review. The project performance is in compliance with EPA's current FIFRA Good Laboratory Practices Standards (40 CFR 160). II. TEST SUBSTANCE Test substance information is shown below and active ingredient concentrations are provided in Table 1. All ZeroMold Plus product tested was previously titrated and diluted according to the manufacturer s instructions to ensure compliance with EPA guidance on lower certified limit (LCL) (SwRI GLP-SP-210 study). Product Name: ZeroMold Plus Active Ingredient: NaClO Lower Certified Limit (LCL): 0.43% Acceptable Active Ingredient Concentration for Efficacy Testing: 0.43%-0.44% (2% above LCL) Storage Conditions: Ambient Temperature, cap closed (all lots tested) Test Substance Spray Conditions (as follows): Distance = 6-8" Number of pumps = 4 Contact Time = 10 minutes Exposure Temperature = C (room temperature) Table 1. Test Substance Active Ingredient Concentration (LCL to up to 2% above LCL) Active ingredient ZeroMold Plus Test Batch/Lot Information (NaClO) concentration Concentration/Dilution Tested 48536, Lot #2 (B1#0018-6), >60 days 0.44% 48540, Lot #4 (B1#0020-2), >60 days 0.44% Ready-to-use, Trigger Spray III. STUDY PERSONNEL XingGuo Cheng, Study Director at SwRI Jamie Herzan, Study Director at ATS Labs, MN (ATS has provided their personnel details in Appendix 2) All study personnel have received training in Good Laboratory Practices standards and are experienced in their area of responsibility. Resumes and training records for these personnel are maintained with SwRI s and ATS s Quality Assurance Unit.

7 Southwest Research Institute Page 7 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 IV. EXPERIMENTAL METHODS AND RESULTS Experimental Methods The general experimental method for Association of Official Analytical Chemists (AOAC) Germicidal Spray Testing is summarized in Figure 1 below. Briefly, bacteria-loaded carriers were prepared and sprayed with ZeroMold Plus using 4 sprays at a distance of 6-8 inches and held covered for 10 min. The carriers were recovered under neutralization subculture media. Carriers were incubated and observed for growth. Appropriate study controls were performed and confirmed. Figure 1. General test procedure for AOAC germicidal spray test of ZeroMold Plus disinfectant Results Acinetobacter baumannii Multi-drug Resistant (MDR) (ATCC #19606) The controls and test substance assay results are summarized in Table 2. Controls and neutralization results are in compliance with the ATS test protocol (SWT GS) study acceptance criteria. Under the conditions of this

8 Southwest Research Institute Page 8 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 investigation, ZeroMold Plus, ready to use as a trigger spray, demonstrated complete inactivation of Acinetobacter baumannii Multi-drug Resistant (MDR) (ATCC #19606) following 10-minute exposure at room temperature as required by the U.S. EPA, Health Canada, and Australian Therapeutic Goods Administration (TGA). Control and Neutralization Results Control and neutralization results are summarized in Table 2 below. They are in compliance with the acceptance criteria as described in the ATS Labs test protocol (SWT GS). Table 2. Summary of Controls and Neutralization Results (Details shown on Page 15 and 16 of Appendix 2) Purity Control Carrier Sterility Control Viability Control Neutralization Confirmation Pure No growth Growth Growth when inoculated with average 3 and 21 CFU Carrier Population Control (> ) 6.7 x 10 5 (pre-testing) 1.7 x 10 5 (post-testing) Antibiotic Resistance Profile The test organism antibiotic resistance profile met the established criteria (details shown on Page 17 of Appendix 2). Test Carrier Results ZeroMold Plus demonstrated the following results at a 10-minute contact time with no soil load: 10 out of 10 carriers are negative for growth for each lot. ZeroMold Plus at LCL 48536, Lot #2, B1#0018-6, >60 days 48540, Lot #4 (B1#0020-2), >60 days Table 3. Summary of Test Results (details shown on Page 16 of Appendix 2) Number of Soil Carriers Carriers Load Tested Positive Test Organism Acinetobacter baumannii Multi-drug Resistant (MDR) (ATCC #19606) Exposure Contact Temperature Time (ºC) 10 min 21 None Carrier Negative min

9 Southwest Research Institute Page 9 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 V. PROCEDURAL MODIFICATIONS/PROTOCOL AMENDMENTS There were protocol amendments during the course of this study at SwRI. There was one protocol deviation at ATS Labs which consisted of changing the number of daily transfers for the test culture (Page 11 of Appendix 2). ATS test protocol states the test culture can undergo a total of 5 daily transfers. In one testing, the technician inadvertently used a test culture that had undergone 8 daily transfers. That testing deviated from the protocol and it was invalidated (Page 11 of Appendix 2). The repeated study used the culture with the correct number of transfers and the result was reported here. VI. STUDY CONCLUSIONS Under the condition of this study, samples of ZeroMold Plus disinfectant at LCL demonstrated efficacy against the test organism following a 10-minute exposure at room temperature as required by U.S. EPA, Health Canada, and Australian TGA. ZeroMold Plus is qualified as a disinfectant for the Acinetobacter baumannii Multi-drug Resistant (MDR) (ATCC #19606). ATS Labs will maintain all records for a five-year period and will submit to SwRI for final archive. All original records (or exact copies of originals) of final reports will be maintained at SwRI. VII. RECORD & SAMPLE RETENTION In accordance with SwRI TAP , Conduct of a GLP Study, copies of the protocol, appendices, amendments, and the analytical method shall be available to the analysts, technicians and chemists involved in the study at SwRI. The analysts at SwRI shall maintain laboratory notebooks or equivalent documents in which they will record all procedures, weighing, observations, etc., relevant to the experimental work. Chromatograms, computer printouts, etc., will be clearly labeled and notebooks will remain in the analyst's possession throughout the study. Records shall be archived as written in SwRI TAP , Project Setup and Record Archival for GLP. At the completion of the analytical portion of the study, a report shall be prepared as specified in SwRI TAP , Final Report for GLP Studies, and delivered to the sponsor for final approval. After completion of the final report for the study, all methodology, raw data sheets, and original chromatograms will be inspected by the QAU at SwRI. At the sponsor's discretion, all original records will be sent to sponsor for archiving in accordance with 40 CFR 160. The study for a research or marketing permit approved by EPA shall be maintained for the period during which the sponsor holds that research or marketing permit to which the study is pertinent unless all originals are provided to the client. For samples remaining at the conclusion of the study, SwRI will either have samples returned to the sponsor or disposed after five years from market permit submission to EPA. Materials that degrade will not be maintained. VIII. REFERENCES Association of Official Analytical Chemists (AOAC) Official Method , Germicidal Spray Products as Disinfectants. In Official Methods of Analysis of the AOAC, 2012 Edition.

10 Southwest Research Institute Page 10 of 10 Microencapsulation and Nanomaterials Department Final Report: GLP Testing of ZeroMold Plus for Acinetobacter baumannii Protocol No.: GLP-SP-242 CAN/CGSB Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surface and Medical Devices. Disinfectants for Use on Hard Surfaces. EFFICACY DATA REQUIREMENTS: Supplemental Efficacy. DRAFT GUIDELINES FOR THE EVALUATION OF HOUSEHOLD/COMMERCIAL AND HOSPITAL GRADE DISINFECTANTS Australian Therapeutic Goods Administration (TGA), July IX. APPENDIX SwRI GLP protocol and ATS test report are provided in the following appendices. Appendix 1: SwRI GLP study protocol. Appendix 2: ATS GLP final study report and protocol (ATS project number A17564)

11 Southwest Research Institute Page 1 of 5 Microencapsulation and Nanomaterials Department SwRI Project Title: GLP Testing of ZeroMold Plus for Acinetobacter baumannii GLP-SP-242 GLP-SP-242 STUDY PROTOCOL GLP Testing of ZeroMold Plus for Acinetobacter baumannii SOUTHWEST RESEARCH INSTITUTE STUDY NUMBER DATA REQUIREMENTS OCSPP TESTING FACILITY ATS Labs, Inc. (ATS) 1285 Corporate Center Drive, Suite 110 Eagan, MN Phone: Fax: Southwest Research Institute (SwRI ) Microencapsulation and Nanomaterials Department 6220 Culebra Road San Antonio, TX USA Tel: Fax: SPONSOR BIOSENTA Inc Finch Ave, West Suite 503 Toronto, Ontario, M3J 3H7 CANADA PH:

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14 Southwest Research Institute Page 3 of 5 Microencapsulation and Nanomaterials Department SwRI Project Title: GLP Testing of ZeroMold Plus for Acinetobacter baumannii GLP-SP OBJECTIVE BIOSENTA Inc. is interested in assessing its ZeroMold Plus Product as an intermediate and/or low-level disinfectant that kills pathogenic and potentially pathogenic microorganisms on hard non-porous inanimate surfaces or inanimate objects, when used according to labeling. This project plans to perform AOAC germicidal spray test using test organism called Acinetobacter baumannii. Testing will be performed at ATS Labs at the facility addresses provided in the cover. This lab has been audited for the Approved Supplier List. The project will be performed in compliance with EPA's current FIFRA Good Laboratory Practices Standard (40 CFR 160). 2. TEST SUBSTANCES Two lots of ZeroMold Plus at Lower Certified Limit (LCL) will be tested. At least one lot will be aged (>60 days old). BIOSENTA provided the ZeroMold Plus to SwRI. SwRI previously performed titration and dilution of the product to LCL according to GLP protocol (GLP-SP-210) and has shipped the products to ATS Labs for testing. 3. TEST SYSTEM/ANALYTICAL METHOD For testing of ZeroMold Plus efficacy against Acinetobacter baumannii (ATCC # 19606), ATS Labs will provide GLP test protocol/method for AOAC germicidal spray method. This method is in compliance with the requirements of EPA, Health Canada and Australian TGA. 4. JUSTIFICATION OF TEST SYSTEM Association of Official Analytical Chemists (AOAC) Official Method , Germicidal Spray Products as Disinfectants. In Official Methods of Analysis of the AOAC, 2012 Edition. CAN/CGSB Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surface and Medical Devices Disinfectants for Use on Hard Surfaces EFFICACY DATA REQUIREMENTS Supplemental Efficacy DRAFT GUIDELINES FOR THE EVALUATION OF HOUSEHOLD/COMMERCIAL AND HOSPITAL GRADE DISINFECTANTS Australian Therapeutic Goods Administration (TGA), July 2005.

15 Southwest Research Institute Page 4 of 5 Microencapsulation and Nanomaterials Department SwRI Project Title: GLP Testing of ZeroMold Plus for Acinetobacter baumannii GLP-SP STUDY PERSONNEL Xingguo Cheng, SwRI, study director Personnel from ATS Labs, MN (ATS Labs will provide their personnel details) 6. MAJOR EQUIPMENT N/A 7. CALCULATIONS ATS Labs will provide the relevant calculations on the GLP protocol. 8. QUALITY ASSURANCE/GOOD LABORATORY PRACTICES SwRI maintains a Quality Assurance Unit/Division Quality Assurance (QAU/DQA)) in compliance with EPA's current FIFRA Good Laboratory Practices Standard (40 CFR 160). The QAU/DQA will conduct periodic inspections of this study to assure conformance to the study protocol, standard operating procedures and GLP. The inspection results will be reported to SwRI management and the SwRI study director through the Quality Reporting System. The final report will be reviewed by the QAU/DQA, and a signed Quality Assurance Statement will be included which specifies the date inspections/audits were made and reported to SwRI management and the SwRI study director. 9. RECORDS TO BE MAINTAINED In accordance with SwRI TAP , Conduct of a GLP Study, copies of the protocol, appendices, amendments, and the analytical method shall be available to the analysts, technicians and chemists involved in the study at SwRI. The analysts at SwRI shall maintain laboratory notebooks or equivalent documents in which they will record all procedures, weighing, observations, etc., relevant to the experimental work. Chromatograms, computer printouts, etc., will be clearly labeled and notebooks will remain in the analyst's possession throughout the study. Records shall be archived as written in SwRI TAP , Project Setup and Record Archival for GLP. Training records shall be maintained for appropriate procedures and Protocols. At the completion of the analytical portion of the study, a report shall be prepared as specified in SwRI TAP , Final Report for GLP Studies, and delivered to the sponsor for final

16 Southwest Research Institute Page 5 of 5 Microencapsulation and Nanomaterials Department SwRI Project Title: GLP Testing of ZeroMold Plus for Acinetobacter baumannii GLP-SP-242 approval. Following completion of the final report for the study, all methodology, raw data sheets, and original chromatograms will be inspected by the QAU/DQA at SwRI. At the sponsor's discretion, all original records will be sent to the sponsor for archiving in accordance with 40 CFR Part SAMPLE AND RECORD RETENTION The study for a research or marketing permit approved by EPA shall be maintained for the period during which the sponsor holds that research or marketing permit to which the study is pertinent unless all originals are provided to the client. For samples remaining at the conclusion of the study SwRI will either return samples to the sponsor or dispose the sample after which the sponsor holds that research or marketing permit to which the study is pertinent unless all originals are provided to the client (EPA). Materials that degrade will not be maintained.

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