AMTicide Coconut. Technical Dossier. Code Number: M14003 INCI Name: Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract

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Technical Dossier abilitynaturalcoconutstechnologyactivity moisturizingcosmosconditioningfermentation sustainabilitybenefitsecocertlactobacillus alternativessolarchoiceantifungal AMTicide Coconut Code
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Technical Dossier abilitynaturalcoconutstechnologyactivity moisturizingcosmosconditioningfermentation sustainabilitybenefitsecocertlactobacillus alternativessolarchoiceantifungal AMTicide Coconut Code Number: M14003 INCI Name: Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract Table of Contents I. Technical Data Sheet II. Specification Sheet III. Compositional Breakdown IV. Efficacy Tests a. Generic Cream Challenge Test at 4.0% b. Inhibition Activity Data c. Moisturization Assay d. Zone of Inhibition at 4.0% e. Challenge Test with 2.0% AMTicide Coconut + 2.0% Leucidal Liquid f. Challenge Test with 2.0% AMTicide Coconut + 2.0% Leucidal Liquid SF g. Challenge Test with 4.0% AMTicide Coconut + 2.0% Leucidal Liquid h. Challenge Test with 4.0% AMTicide Coconut + 2.0% Leucidal Liquid SF V. Safety Information a. Safety Statement b. Dermal and Ocular Irritation Test c. Direct Peptide Reactivity Assay d. RIPT e. 48 Hour Patch Test f. OECD 202 Acute Daphnia Assay g. OECD 301B Ready Biodegradability Assay h. AMES Test VI. Certificate of Origin VII. Material Safety Data Sheet (SDS) VIII. Additional Documentation a. Manufacturing Flow Chart b. Certificate of Compliance AMTicide Coconut Code Number: M14003 INCI Name: Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract AMTicide Coconut Patent Pending: Application Number 62/139,908 Technical Data Sheet BACKGROUND Fueled by the ever-changing regulations and the increasing safety concerns, among consumers, we must steer away from synthetics and focus on natural solutions. AMTicide Coconut is developed by fermenting Cocos nucifera (Coconut) fruit with Lactobacillus to deliver a non-irritating, effective and multifunctional product. This highly marketable product can provide moisturizing and conditioning benefits in hair and skin care applications. In addition, it is effective at preventing the growth of fungus, specifically yeast and mold, thus providing the perfect addition to any formulation. As we know, the use of parabens and formaldehyde donor materials are coming to a screeching halt, as controversy continues to surround them. When companies began phasing out parabens and formaldehyde donor materials, they replaced them with ingredients that dissociate into formaldehyde when put in an aqueous solution, such as DMDM Hydantoin. This option is not only cost effective but also protected formulas against bacteria, yeast and mold, which made the life of formulators seemingly effortless. However, as consumers continue to focus on natural solutions, these products are no longer an acceptable option. Code Number: M14003 INCI Nomenclature: Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract INCI Status: Approved REACH Status: Fully Compliant CAS Number: & EINECS Number: Origin: Biotechnology/Botanical: Lactobacillus & Cocos nucifera Processing: GMO Free No Ethoxylation No Irradiation No Sulphonation No Ethylene Oxide treatment No Hydrogenation Additives: None -Preservatives: None -Antioxidants: None Other additives: None Solvents used: Water Appearance: Clear to Slightly Hazy Liquid Soluble/Miscible: Water Suggested Use Levels: % Suggested Applications: Moisturization, Skin/Scalp Conditioning, Antifungal This leads the quest for natural antimicrobial products that can suit the needs of formulators and ultimately consumers. The challenge is not only finding one product that will protect against a wide range of microorganisms but also finding another product to supplement it, for protection that will not fail. How do we achieve the protection we need in a formulation without adding any synthetic ingredients? Version Page 1 of 5 Active Micro Technologies, LLC Technology Drive - Lincolnton, NC USA - Phone (704) Fax (704) Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, however, cannot assume any liability or risk involved in the use of its chemical products since the conditions of use are beyond our control. Statements concerning the possible use of our products are not intended as recommendations to use our products in the infringement of any patent. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specification. Freedom from patent infringement is not implied. All information is for investigative purposes only. AMTicide Coconut Patent Pending: Application Number 62/139,908 SCIENCE Active Micro Technologies has prided itself in developing and supplying effective, natural products that provide skin and hair conditioning benefits, along with providing natural antimicrobial activity. As our original Leucidal Liquid product line continues to flourish, we still had the need for an antifungal product to round out our portfolio. This need left us with a long road of trial and error, in efforts to develop a marketable, yet effective antifungal booster. AMTicide Coconut was developed to be used in conjunction with one of our broad-spectrum antimicrobials, however it can be used alongside any preservative package for extra protection against yeast and mold. We began investigating the antimicrobial effects of medium chain triglycerides (MCT s), which have been studied for years. MCT s, including lauric acid, have natural antifungal activity and work by disrupting the cellular structures of fungus, thus essentially destroying them before they can wreck havoc. This led us to an exotic oil that is rich in MCT s - the well-known coconut oil. Coconut oil has been an important component of the Ayurveda tradition, popular among people of the tropics and currently at the center of a health craze in the U.S. First, it was coconut water for hydration, then coconut oil for health and now coconut is popping up in just about every industry. We cannot seem to get away from this fruit and for good reason. So what makes coconut oil so unique? As mentioned, coconut oil is rich in MCT s, particularly lauric acid, which comprises ~50% of its total fatty acid content. Coconut oil was traditionally used to treat skin disorders, yeast infections, ringworm and even athletes foot. What many of these skin issues had in common was that they were all a type of yeast infection. Yeast and mold are types of fungus that can be inconspicuous because of their small size and structure and can flourish in our favorite skin care and cosmetic products. This can lead to not only destruction of that lotion you love, but it can also create a health hazard. Natural antimicrobial products are similar to synthetic preservatives systems, in that they are effective against bacteria, however not as effective against fungus, specifically yeast and mold. One of the first steps in the development of this product was to determine the products potential ability to inhibit the growth of yeast and mold. Using standard serial dilution protocols in growth media, the Minimum Inhibitory Concentrations (MICs) for AMTicide Coconut were determined for both yeast and mold organisms. Microorganisms Tested MIC (%) Version A. brasiliensis 0.50 C. albicans 0.50 Table 1. MIC Data for AMTicide Coconut. Page 2 of 5 Active Micro Technologies, LLC Technology Drive - Lincolnton, NC USA - Phone (704) Fax (704) Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, however, cannot assume any liability or risk involved in the use of its chemical products since the conditions of use are beyond our control. Statements concerning the possible use of our products are not intended as recommendations to use our products in the infringement of any patent. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specification. Freedom from patent infringement is not implied. All information is for investigative purposes only. AMTicide Coconut Patent Pending: Application Number 62/139,908 The positive MIC screening results warranted further testing to confirm its ability to provide product preservation. A Double Challenge Test was completed using 2% AMTicide Coconut by itself and AMTicide Coconut with Leucial Liquid in a generic cream base formulationat a ph of 7. Samples were inoculated with the microorganisms E. Coli, P. aeruginosa, S. aureus, A. brasiliensis and C. albicans. During the first 28-day incubation period, samples were periodically collected and tested for the presence of these fungi. Following this initial 28 days of incubation, the cream samples were then re-inoculated with the cultures and sampled over an additional 28-day period. Tables 2 and 3 shows the positive antifungal results for AMTicide Coconut. Inoculum (initial) CFU/ml Challenge Test Results AMTicide Coconut Organisms E. coli P. A. S. aureus aeruginosa brasiliensis C. albicans 8.4 x x x x x 10 5 Day 0 * % % Day 7 99.000% 99.000% 99.000% 99.999% Day 14 99.000% 99.000% 99.000% 99.999% 99.999% Day 21 99.000% 99.000% 99.000% 99.999% 99.999% Day 28 99.000% 99.000% 99.000% 99.999% 99.999% Inoculum (initial) CFU/ml 3.5X X X X X10 5 Day 7 99.000% 99.000% 99.000% 99.999% 99.999% Day 14 99.000% 99.000% 99.000% 99.999% 99.999% Day 21 99.000% 99.000% 99.000% 99.999% 99.999% Day 28 99.000% 99.000% 99.000% 99.999% 99.999% Table 2. Challenge Test results for Generic Cream Formula ph 7 with 2% AMTicide Coconut inoculated on Day 0 and re-inoculated on Day 28. Results show % reduction in viable organisms. Version Page 3 of 5 Active Micro Technologies, LLC Technology Drive - Lincolnton, NC USA - Phone (704) Fax (704) Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, however, cannot assume any liability or risk involved in the use of its chemical products since the conditions of use are beyond our control. Statements concerning the possible use of our products are not intended as recommendations to use our products in the infringement of any patent. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specification. Freedom from patent infringement is not implied. All information is for investigative purposes only. AMTicide Coconut Patent Pending: Application Number 62/139,908 Inoculum (initial) CFU/ml Challenge Test Results AMTicide Coconut + Leucidal Liquid Organisms E. coli P. A. S. aureus aeruginosa brasiliensis C. albicans 4.5 x x x x x 10 5 Day 0 * % % Day 7 99.999% 99.999% 99.999% 99.999% Day 14 99.999% 99.999% 99.999% 99.999% 99.999% Day 21 99.999% 99.999% 99.999% 99.999% 99.999% Day 28 99.999% 99.999% 99.999% 99.999% 99.999% Inoculum (initial) CFU/ml 3.5X X X X X10 5 Day 7 99.999% 99.999% 99.999% 99.999% 99.999% Day 14 99.999% 99.999% 99.999% 99.999% 99.999% Day 21 99.999% 99.999% 99.999% 99.999% 99.999% Day 28 99.999% 99.999% 99.999% 99.999% 99.999% Table 3. Challenge Test results for Generic Cream Formula ph 7 with 2% AMTicide Coconut and 2% Leucidal Liquid inoculated on Day 0 and re-inoculated on Day 28. Results show % reduction in viable organisms. Version BENEFITS Not only is coconut a fruit with powerful benefits but it also complies with our stringent sustainability standards. We have an array of coconut products, which leaves us with unused portions of this multifunctional fruit. As we continued the development process, we began utilizing the lipid fractions of the unused coconut pericarp, which allowed us to further optimize material usage and coincide with our sustainability commitment. In addition, we incorporated our specialty technique of LAB (lactic acid bacteria) fermentation. Fermentation is an important process that can increase the bioavailability of natural phytocompounds, which can uncover wide array of benefits. A next generation, natural antifungal product was born. Page 4 of 5 Active Micro Technologies, LLC Technology Drive - Lincolnton, NC USA - Phone (704) Fax (704) Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, however, cannot assume any liability or risk involved in the use of its chemical products since the conditions of use are beyond our control. Statements concerning the possible use of our products are not intended as recommendations to use our products in the infringement of any patent. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specification. Freedom from patent infringement is not implied. All information is for investigative purposes only. AMTicide Coconut Patent Pending: Application Number 62/139,908 An in-vivo study was also conducted over the course of three weeks to evaluate AMTicide Coconut s ability to increase moisturization. Ten (M/F) subjects between the ages of participated in the study. A DermaLab Corneometer was used to measure the moisture levels on the subject s volar forearms. The Corneometer is an instrument that measures the amount of water within the skin. Baseline measurements were taken on day one of the study. Following initial measurements, all subjects were to apply 2 mg of the positive control and test material to the denoted area on their respective forearms, twice a day for three weeks. The test material consisted of 2.0% AMTicide Coconut + Base Lotion and the positive control (base lotion) used was Cetaphil Moisturizing Lotion for All Skin Types. 120 Moisturization Results Percent (%) Difference Base Lotion vs. Untreated Control Experimental (2% AMTicide Coconut + Base Lotion) vs. Untreated Control 20 0 T = 0 T = 24 Hours T = 1 Week T = 2 Weeks T = 3 Weeks T = 4 Weeks Experimental (2% AMTicide Coconut + Base Lotion) vs. Base Lotion Graph 1. Increase in Moisturization after application of 2% AMTicide Coconut. AMTicide Coconut was developed to be coupled with one of our broad-spectrum antimicrobials, such as Leucidal Liquid, or perhaps any preservative package that is lacking protection, against yeast and mold. This added boost of antifungal activity is the natural additive that will protect your product and consumers. Say goodbye to using potassium sorbate or sodium benzoate for added protection. Replace them with an eco-friendly, marketable and consumer acceptable antifungal product for the protection, and brand differentiation your product craves. Version USE RECOMMENDATIONS As with all biological materials, some attention must paid to the conditions under which AMTicide Coconut is used. Based on bench-scale evaluations, as well as actual product applications, AMTicide Coconut has been found to be effective over a wide range of typical cosmetic and personal care product manufacturing conditions. The product has been found to be heat stable up to 70 C and active under both acidic (ph 3) and basic conditions (ph 8). Page 5 of 5 Active Micro Technologies, LLC Technology Drive - Lincolnton, NC USA - Phone (704) Fax (704) Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, however, cannot assume any liability or risk involved in the use of its chemical products since the conditions of use are beyond our control. Statements concerning the possible use of our products are not intended as recommendations to use our products in the infringement of any patent. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specification. Freedom from patent infringement is not implied. All information is for investigative purposes only. 107 Technology Drive Lincolnton, NC Patent Pending: Application Number 62/139,908 Specification Product Name: AMTicide Coconut Code Number: M14003 CAS # s: & EINECS # s: N/A & INCI Name: Lactobacillus & Cocos Nucifera (Coconut) Fruit Extract Specification Parameter Appearance Color Odor ph Solids (1g-105 C-1hr) Heavy Metals Arsenic Minimum Inhibitory Concentration 1 Organism (ATCC#) C. albicans (#10231) A. brasiliensis (#16404) Clear to Slightly Hazy Liquid 5 Gardner Maximum Characteristic % 20 ppm 2 ppm % % DO NOT FREEZE; Store at or near room temperature; Mix well prior to use; May Sediment upon Standing Note: 1) Refer to Inhibition Activity Data Version#2/ /Form#1 Compositional Breakdown 107 Technology Drive Lincolnton, NC AMTicide Coconut Code: M14003 Compositional Breakdown: Ingredient % Lactobacillus Cocos Nucifera (Coconut) Fruit Extract To our knowledge the above material is free of the following list of heavy metals: - Heavy Metals 20 ppm (Max.) - Lead 10 ppm (Max.) - Antimony 5 ppm (Max.) - Arsenic 2 ppm (Max.) - Mercury 1 ppm (Max.) - Cadmium 1 ppm (Max.) Version#1/ /Form#4 Compositional Breakdown 107 Technology Drive Lincolnton, NC This is to certify that the following allergens were not detected in AMTicide Coconut: INCI NAME ALLERGENS Dir CEE Alpha-IsoMethyl Ionone Amyl Cinnamal Anise Alcohol Benzyl Alcohol Benzyl Benzoate Benzyl Cinnamate Benzyl Salicylate Butylphenyl Methylpropional Cinnamal Cinnamyl Alcohol Citral Citronellol Coumarin Eugenol Farnesol Geraniol Hexyl Cinnamal Hydroxycitronellal Hydroxymethylpentyl 3-Cyclohexene carboxaldehyde Isoeugenol Limonene Linalool Methyl 2 Octynoate Evernia prunastri Evernia furfuracea Amylcinnamyl Alcohol CAS NUMBER Version#1/ /Form#4 Compositional Breakdown 107 Technology Drive Lincolnton, NC This is to certify that AMTicide Coconut does not contain pesticide levels exceeding the following: INCI NAME EPA Pesticide Levels Alachlor 0.02 Aldrin and Dieldrin 0.05 Azinphos-methyl 1.00 Bromopropylate 3.00 Chlordane(cis and trans) 0.05 Chlorfenvinphos 0.50 Chlorpyrifos 0.20 Chlorpyrifos-methyl 0.10 Cypermethrin 1.00 DDT 1.00 Deltamethrin 0.50 Diazinon 0.50 Dichlorvos 1.00 Dithiocarbamates 2.00 Endosulfan 3.00 Endrin 0.05 Ethion 2.00 Fenitrothion 0.50 Fenvalerate 1.50 Fonofos 0.05 Heptachlor 0.05 Hexachlorobenzene 0.10 Hexachlorocyclohexane 0.30 Lindane 0.60 Malathion 1.00 Methidathion 0.20 Parathion 0.50 Version#1/ /Form#4 LIMIT (mg/kg) Parathion-methyl 0.20 Permethrin 1.00 Phosalone 0.10 Piperonyl butoxide 3.00 Pirimiphos-methyl 4.00 Pyrethrins 3.00 Quintozene(sum of 3 items) 1.00 Compositional Breakdown 107 Technology Drive Lincolnton, NC Version#1/ /Form#4 107 Technology Drive Lincolnton, NC Antimicrobial Efficacy Test PCPC Section 20 Method 3 Determination of Preservation Adequacy of Water- Miscible Personal Care Products Product AMTicide Coconut Test Request #: 1153 Purpose This study was initiated to determine the efficacy of a cosmetic ingredient with antimicrobial properties in a cream formulation against bioburden as a function of time. Study Dates The study was started on January 12 th, 2015 and was completed on March 9 th, Test Organisms 1. Escherichia coli: ATCC # Pseudomonas aeruginosa: ATCC # Staphylococcus aureus: ATCC # Aspergillus brasiliensis: ATCC # Candida albicans: ATCC #10231 Neutralization: Verification of neutralization of the antimicrobial properties of the product was demonstrated prior to performing the test for microbial content by inoculating the product dilution with a low level of challenge microorganisms (100 CFU) and verifying recovery of this viable inoculum. This provides evidence that the antimicrobial has been neutralized and there are no false positive results during the Challenge Test. Page 1 of 5 Version#1/ /Form#79 107 Technology Drive Lincolnton, NC Test Method Fifty grams of Generic Cream Formula ph 7 with 4% AMTicide Coconut was weighed into five individual containers. Each container was inoculated with one of the five test organisms. The inoculum concentration for each organism was standardized using the 0.5 McFarland turbidity standard and further diluted to yield approximately 10 6 to 10 8 microo
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