Mikrokill ECT (patent pending) Broad Spectrum, Paraben-Free and Formaldehyde-Free Preservation System that meets the ECOCERT standards. SAP Code#: 139650 Assigned INCI Designation: Benzyl Alcohol & Salicylic Acid & Glycerin & Sorbic Acid Introduction Arch Personal Care Products has recognized the growing market need for a cosmetic preservative that has a wide range of global regulatory acceptance that also meets the ECOCERT standards. Due to customers requiring ingredients that meet the ECOCERT standards as well as the continued concern with conventional preservative systems based upon Formaldehyde Donors, Parabens and Isothiazolones, we have developed Mikrokill ECT to meet the more stringent needs of today s market. Mikrokill ECT is a unique, patent pending combination of 4 components (see Figure 1) Benzyl Alcohol, Salicylic Acid, Glycerin, and Sorbic Acid, which are well accepted in a wide range of personal care products. The novel composition of this antimicrobial blend offers broad spectrum protection in a diverse range of products, against Gram-positive & Gram-negative bacteria, yeast, and molds. Figure 1: Component Structures of Mikrokill ECT O Benzyl Alcohol Salicylic Acid O HO Glycerin Sorbic Acid 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. The customer must insure that its uses of our products are non-infringing. These products are for industrial use only. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specification.
page 2 Advantages to using Mikrokill ECT are: A preservation system that meets the ECOCERT standards Non-paraben, non-formaldehyde, non-isothiazolone based system Broad spectrum activity on bacteria, yeast and molds Has a wide range of global regulatory acceptance Low odor profile; Ideal for fragrance-free and fragrance-sensitive systems Compatible in a wide range of skin care, hair care and sun care systems Wide ph compatibility: (ph 3 8) Excellent safety profile Applications, Solubilities and Formulating Tips Mikrokill ECT is a versatile, clear liquid preservative system that can be easily added directly to most any system and is compatible with most ingredients used in the Personal Care Industry. For emulsified systems, Mikrokill ECT can be easily integrated post-emulsification at temperatures below 45 C. There are limited ph restrictions when using Mikrokill ECT in formulations. Solvent Mikrokill ECT Solubility Test Mikrokill ECT : Solvent 1 : 9 Mikrokill ECT : Solvent 1 : 1 Mikrokill ECT : Solvent 9 : 1 Water IS IS IS Glycerin S S S Dipropylene Glycol S S S Butylene Glycol S S S Propylene Glycol S S S Hexylene Glycol S S S Pentylene Glycol S S S Canola Oil S S S Mineral Oil #70 D IS IS Ethanol S S S Isopropanol S S S Ethylhexyl Palmitate D S S Isododecane IS IS IS Ethyhexyl Methoxycinnamate D S S Ethylhexyl Salicylate D S S Dimethicone IS IS IS Cyclomethicone D IS S 50 % SLES in Water S IS IS PhytoTerra Organic Baobab Oil* S S S Gel Base BSM5* IS IS IS Amaranth Pro* D IS D Liquiwax PolyNH* S S S Liquiwax DIADD* S S S Liquiwax DICDD* S S S *Arch Personal Care Products IS: Insoluble S: Soluble D: Dispersible
page 3 The recommended use level of Mikrokill ECT is 1.0%, however, every personal care formulation requires special attention. It is always important to ensure that every newly developed or altered formulation be challenge tested to guarantee proper preservation. Microbiological Activity Mikrokill ECT is effective against both Gram-positive and Gram-negative bacteria, yeasts and molds. Organism ATCC # Mikrokill ECT (ppm) Gram-negative bacteria Burkholderia cepacia 25416 1250 Escherichia coli 8739 5000 Enterobacter gergoviae 33028 2500 Enterobacter aerogenes 13048 5000 Flavobacterium odoratum IMI 13294 2500 Klebsiella pneumoniae 4352 5000 Proteus mirabilis 9240 5000 Pseudomonas aeruginosa 9027 5000 Gram-positive bacteria Staphylococcus aureus 6538 5000 Staphylococcus epidermidis 12228 5000 Yeast Candida albicans 10231 2500 Saccharomyces cerevisiae 7752 2500 Mold Aspergillus niger 16404 2500 Penicillium sp. Cosmetic isolate 2500 Minimum Inhibitory Concentrations (MIC) Microbiological Challenge Studies Since many cosmetic and toiletry products are used on a regular basis, an effective preservative system should ensure the reduction of microorganisms to a low and steadily decreasing level, even after severe microbial insult. The following criteria are recommended: A. Bacteria there should be at least a 99.9% reduction of vegetative bacteria within 7 days following each challenge and no increase for the duration of the test period. B. Yeasts and Molds There should be at least a 90% reduction of yeasts and molds within 7 days following each challenge and no increase for the duration of the test period. Conditions The tests should be carried out for a minimum of 28 days. At least one rechallenge is recommended. If a product does not meet these criteria, additional evaluations should be considered. It is the responsibility of the manufacturer to select an appropriate methodology and appropriate criteria.
page 4 Studies were run on five formulas using a 1.0% concentration of Mikrokill ECT. The protocol used was a CTFA challenge test. All samples were inoculated at the beginning of the study, sampled at 24 hours, 7, 14, 21 and 28 days. The samples were diluted in neutralizer and plated quantitatively for viable organisms at all sampling times. After 28 days, all samples were re-inoculated and subjected to a second challenge. Make-Up Remover (Lot# AR12-067) ph: 5.15 % water: 90%; A w : 0.980 Deionized Water q.s to 100 Propylene Glycol 2.00 Glycerin 2.00 PEG-8 2.00 Decyl Glucoside 4.00 S. aureus 9.0x10 1 <10 <10 2.0x10 1 <10 <10 K. pneumoniae + E. gergoviae 5.3x10 3 <10 <10 4.0x10 1 <10 <10 P. aeruginosa + B. cepacia 3.3x10 5 1.4x10 6 7.7x10 6 1.0x10 1 <10 <10 C. albicans 1.8x10 4 1.2x10 4 1.5x10 4 <10 <10 <10 Mixed Molds 1.5x10 4 1.1x10 4 7.0x10 4 <10 <10 <10
page 5 Hair Conditioner (Lot# AR12-069) ph: 3.9 % water: 73.7%; A w : 0.976 Phase A Deionized Water q.s. to 100 Hydroxyethylcellulose 0.30 Phase B Cetrimonium Bromide & Cetearyl Alcohol 1.00 Stearyl Alcohol 1.00 Steareth-21 2.50 Polysorbate 80 0.50 Lecithin 1.00 Water 20.00 S. aureus 3.5x10 5 <10 <10 <10 <10 <10 K. pneumoniae + E. gergoviae 9.4x10 5 2.6x10 8 3.5x10 6 <10 <10 <10 P. aeruginosa + B. cepacia 4.9x10 5 3.0x10 8 >10 8 2.0x10 2 <10 <10 C. albicans 3.3x10 5 2.7x10 6 2.8x10 7 6.0x10 1 <10 <10 Mixed Molds 2.1x10 4 1.2x10 3 1.4x10 4 <10 <10 <10 Make-Up Remover (Lot# KKL-1445) ph: 8.1 % water: 44%; A w : 0.965 Deionized Water q.s to 100 Propylene Glycol 2.00 Glycerin 2.00 PEG-8 2.00 Decyl Glucoside 50.00
page 6 S. aureus 1.0x10 2 <10 <10 <10 <10 <10 K. pneumoniae + E. gergoviae 5.1x10 6 2.5x10 6 8.0x10 5 <10 <10 <10 P. aeruginosa + B. cepacia 4.5x10 6 1.5x10 6 3.2x10 6 <10 <10 <10 C. albicans 4.0x10 2 <10 <10 <10 <10 <10 Mixed Molds 1.1x10 4 2.0x10 4 1.0x10 5 <10 <10 <10 Water in Oil Emulsion Cream (Lot#: AR12-068) ph: N/A % water: 75%; A w : 0.963 Phase A Deionized Water q.s. to 100 Glycerin 3.00 Sodium Chloride 1.00 Phase B Cyclomethicone & Dimethicone 10.00 Cyclopentasiloxane 8.50 Cyclomethicone & Dimethicone & Petrolatum 2.50 S. aureus 8.6x10 4 <10 <10 <10 <10 <10 K. pneumoniae + E. gergoviae 5.6x10 4 <10 <10 <10 <10 <10 P. aeruginosa + B. cepacia 3.1x10 4 <10 3.4x10 5 <10 <10 <10 C. albicans 4.6x10 4 2.9x10 3 5.3x10 4 <10 <10 <10 Mixed Molds 1.2x10 4 7.0x10 3 3.4x10 5 <10 <10 <10
page 7 Lotion (Lot #KKL-1446) ph: 7.85 % water: 89%; A w : 0.976 Deionized Water q.s. to 100 Glycerin 2.00 Cyclomethicone & Dimethicone & Phenyl Trimethicone 2.00 Cyclopentasiloxane 5.00 Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer & Hydrogenated Polydecane 2.00 & Sorbitan Laurate & Trideceth-6 S. aureus 1.3x10 6 3.0x10 4 8.0x10 3 7.0x10 1 <10 <10 K. pneumoniae + E. gergoviae 1.3x10 6 7.0x10 5 2.3x10 3 2.0x10 1 <10 <10 P. aeruginosa + B. cepacia >10 6 4.3x10 7 9.8x10 7 <10 <10 <10 C. albicans 1.1x10 5 9.0x10 5 1.5x10 5 8.7x10 3 <10 <10 Mixed Molds 2.3x10 6 1.6x10 4 7.0x10 4 1.8x10 3 <10 <10
page 8 Mikrokill ECT Typical Properties Appearance Clear, colorless to straw Odor Characteristic Color (Gardner) 2 Max. Specific Gravity @ 21 C 1.018 1.118 Recommended Use Level 1.0% Regulatory Status CAS Number: 100-51-6 & 69-72-7 & 56-81-5 & 110-44-1 EINECS Number: 202-859-9 & 200-712-3 & 200-289-5 & 203-768-7 Pre-registered with REACh Conclusions Mikrokill ECT is effective in protecting various types of cosmetic formulations from contamination. Yet, it remains the responsibility of the manufacturer to check the preservative s protection in the specific formulation in normal use conditions.