HYAMINE 1622 EPA Registered CAS Number 121-54-0 Hyamine 1622 microbiocide is a crystalline quaternary ammonium compound. Hyamine 1622-50 percent is a 50 percent active concentrate. These compounds are effective in low concentrations against a wide variety of microorganisms. In suitable formulations the Hyamine products provide bactericidal and deodorant action. The crystalline form of Hyamine 1622 is readily soluble in water and other solvents. It can be formulated into powdered or liquid products for industrial or household sanitizers and disinfectants. Hyamine 1622 may also be useful in veterinary and proprietary pharmaceutical products as preservatives or antimicrobial agents for topical applications. Hyamine germicides are not corrosive to environmental surfaces when used according to directions. Typical Chemical Composition Hyamine 1622 Hyamine 1622 50% Crystals Active Ingredient Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride (MW = 448.1) 50% 100% Inert Ingredient 50% 0% Physical Properties % Quaternary @ MW = 448.1 47.5-52.5 No Spec. % Ionizable Chloride No Spec. 7.70-8.00 Color (APHA) 150 Max. 40 Max. (@ 10%Solution) ph (5% as is) 8-10 No Spec. Physical State Liquid Powder Flash Point (Seta Flash) 110 F N/A Specific Gravity @ 25 C 1.03 0.44g/cc (density) (8.56 lbs./gal. (27.5 lbs./ft 3 ) Specifications are based upon Lonza analytical test methods, copies of which are available upon request. The seller makes no warranty, expressed or implied, concerning the accuracy of any results to be obtained from the use of this information and no warranty is expressed or implied concerning the use of these products other than indicated within. The buyer assumes all risks of use and/or handling. No statement is intended or should be construed as a recommendation to infringe any patent Printed in the USA 7-9-07 Page 1 of 6
Solubility: Hyamine 1622 is soluble in water, the lower alcohols, glycols, ethoxyethanol, ethyleneglycol monomethyl ether, tetrachlorethane, and miscible with ethylene dichloride and carbon tetrachloride. It is insoluble in aliphatic hydrocarbons. Compatibility The compatibility of Hyamine 1622 was determined by mixing dilute solutions of the germicide with solutions of substances with which it might be combined in formulations. The presence or absence of turbidity indicates physical compatibility, but final formulations should be carefully evaluated for both physical and bactericidal stability. Compatible Partially Compatible Incompatible Acetic acid Aluminum chloride Borax Calcium chloride Citric acid Nonionic wetting agents Polyoxyalkylene lanolin Potassium hydroxide Sodium acetate Sodium bicarbonate Sodium carbonate Sodium hydroxide Sodium nitrate Sodium sulfate Tetrasodium pyrophosphate Trisodium phosphate Potassium iodide Sodium hexametaphosphate* Sodium metasilicate Sodium tetraphosphate* Sodium tripolyphosphate* Anionic wetting agents Potassium chromate Potassium dichromate Soaps Sodium heptaphosphate *Only in dilute solutions or in the presence of sufficient nonionic wetting agents or other suitable solubilizer. NOTE: Hyamine biocides should not be used or compounded with oxidizing agents such as calcium hypochlorite, nitric acid or solid perchlorates, since mixtures of most organic materials with oxidants may be explosive. AOAC Dilution The AOAC Use Dilution Confirmation Procedure is used to determine the effective disinfectant concentration for hard surfaces using the two basic index bacteria, Staphylococcus aureus and Salmonella choleraesuis. If the product is to be used in hospitals, the effective disinfectant use dilutions for Pseudomonas aeruginosa PRD-10 must also be determined. Page 2 of 6
The effective disinfectant concentrations of Hyamine 1622 (Crystals or 50 percent solution) for the microorganisms are: Disinfectant Disinfectant Concentration Dilution of Active of Active Organism Ingredients, ppm Ingredient Straphylococcus aureus (ATCC 6538) 500 1: 2000 Salmonella choleraesuis (ATCC 10708) 500 1: 2000 Pseudomonas aeruginosa PRD-10 (ATCC 15442) 1000 1: 1000 Microbiostatic and Microbiocidal Titers The maximum microbiostatic and microbiocidal dilutions of Hyamine 1622 are determined by means of serial dilutions in broth tubes inoculated with a fresh culture of the organism to be tested. After 24 hours of incubation, transfers are made from the tubes showing no growth to fresh broth containing a quaternary inactivator. After an additional 24 hours of incubation (total incubation time 48 hours) the initial set of tubes is reexamined for growth. The highest dilution of active ingredient preventing growth in the subculture tubes (quaternary inactivator present) after a total incubation time of 48 hours is the microbiocidal titer. NOTE: These values indicate the effect of Hyamine 1622 on these microorganisms under constant contact conditions as in preservative applications. They should not be interpreted as indicating the effective concentration for disinfecting or sanitizing applications. Microbiostatic and Microbiocidal Titers of Hyamine 1622 Dilution of Active Ingredient Organism Bactericidal Bacteriostatic Streptococcus pyogenes C-203 Streptococcus viridans Escherichia coli Salmonella gallinarum Salmonella choleraesuis Salmonella typhimurium Salmonella schottmulleri Pseudomonas aeruginosa PRD-10 Lactobacillus casei Shigella sonnei Klebsiella pheumoniae Saccharomyces cerevisiae Pityrosporumovale Trichophyton mentagrophytes Monilia albicans Aspergillus niger 1: 50,000 1: 200,000 1: 8,000 1: 8,000 1: 50,000 1: 100,000 1: 20,000 1: 400,000 1: 400 1: 50,000 1: 400,000 1: 8,000 1: 100,000 1: 100,000 1: 40,000 1: 800 Page 3 of 6
Aspergillus oryzae Penicillium notatm Penicillium luteum 1: 400,000 1: 1,600,000 Effect of Hard Water on Antimicrobial Activity Hyamine 1622 retains its effectiveness as a hard-surface disinfectant and preservative in the presence of hard water, but, like other quaternaries, its speed of action is slowed by the presence of calcium and magnesium salts. The effectiveness of hard-surface sanitizers is determined by the AOAC Germicidal and Detergent Sanitizer Test. Since this procedure requires that a 200 ppm active quaternary solution kills 99.999% of an E. coli culture in 30 seconds, the speed of kill is a determining factor in selecting a sanitizing agent. The hard-water ceiling of Hyamine 1622 is relatively low, and it should be formulated with inorganic or organic sequestering agents to improve sanitizing performance in hard water. For 200 ppm active solution of Hyamine 1622, the limiting water hardness of CaC0 3 is 25 ppm. Surface Tension Hyamine 1622 is a surface-active compound and displays typical surfactant characteristics, such as the reduction of surface tension, foaming and penetration. Surface Tension and Interfacial Tension Dynes/Centimeter Hyamine 1622 Active Concentration, % 1.0% 0.1% 0.01% 0.001% Surface Tension Interfacial Tension* *Interfacial Tension vs. Arcoprime 90 Mineral Oil. All data via dunouy tensiometer at 25 C. 33 4.9 30 2.6 45 15.8 55 25.8 Applications Hyamine 1622 Crystals are powdered crystalline quaternary germicides and are especially suited for formulating dry powdered products. By mixing Hyamine crystals with inert compatible diluents, powdered disinfectant or sanitizer formulations can be prepared. Convenience and exactness of dosage contribute to the popularity of tablets. Hyamine 1622 Crystals can be made into sanitizing tablets containing up to 50 percent active quaternary. As noted above, this product has a relatively low hard-water ceiling, and sequestering agents should be employed to improve the efficiency of the product in hard water. The tablet manufacturer should evaluate his final composition by the AOAC Germicidal and Detergent Sanitizer Test to assure proper sanitizing performance in his marketing area. Other excipients, such as lactose, ammonium sulfate, sodium bicarbonate, citric acid and other highly soluble substances, may be used to optimize the physical properties of the finished tablet. Page 4 of 6
Specialty Applications Disinfectant formulations for surgical instruments, antibacterial handwash, barber s tools, and dentures can be prepared in the form of aqueous concentrates, powders, or tablets. A quaternary concentration of 1000 ppm is required for instrument disinfection. Hyamine 1622 finds wide use in the veterinary field as a disinfectant and a deodorant. Tinctures and lotions may be considered for topical antiseptics and for storage of sterile instruments. Pharmaceutical formulations are subject to the New Drug Regulations of the Federal Food, Drug and Cosmetic Act, as amended, pertaining to the safety and effectiveness of such products. Those requiring a USP grade material should refer to our data sheet for Lonzagard USP. General Deodorization Hyamine 1622 is a true deodorant and destroys rather than masks obnoxious odors. Odors due to microbial decomposition are also eliminated by the destruction of the microorganism. A 1:1000 dilution of active ingredient of Hyamine 1622 products, applied by mopping, spraying, or sponging, quickly controls cooking odors, odors of putrefaction or personal illness, and odors in public rooms without contributing a chemical or disinfectant odor. Algae Control The growth of algae in swimming pools can be controlled by very low concentrations of Hyamine germicides. Concentrations of only 10 ppm active Hyamine 1622 kill most strains of algae, and levels of only 5 ppm can maintain algaestatic conditions. Premeasured quantities of Hyamine 1622 Crystals can be packed in water-soluble plastic and added to the water system as required. At the algaecidal concentration of 10 ppm active ingredient, Hyamine 1622 cannot replace chlorine as a disinfectant, but its algaecidal activity helps maintain the chlorine level. Algae, like most organisms, may develop resistance to toxicants and necessitate a change in treatment. Should algae show resistance to Hyamine 1622, a shock treatment with a formulation of Hyamine 3500 at 5 ppm active ingredient is recommended. Safety and Health Information Danger: Keep out of the reach of children. Corrosive. Causes severe eye and skin damage. Do not get in eyes, on skin or on clothing. Wear goggles or face shield and rubber gloves when handling the concentrates. Harmful or fatal if swallowed. Avoid contamination of food. When handling crystals, use an exhaust fan keep dusts away from operators. First Aid: Eyes: Flush eyes with large amounts of running water for at least 15 minutes. Hold eyelids apart to ensure rinsing of the entire surface of the eye and lids with water. If physician not available, flush for additional 15 minutes. Get immediate medical attention. Skin: Wash with large amounts of running water, and soap if available, for 15 minutes. Remove contaminated clothing and shoes. Get immediate medical attention. Wash clothing and decontaminate shoes before reuse. Ingestion: If swallowed, immediately give 3-4 glasses of milk (if unavailable, give water). DO NOT induce vomiting. If vomiting occurs, give fluids again. Have physician determine if patient s condition allows for induction of vomiting or evacuation of the stomach. Do not give anything by mouth to a convulsing or unconscious person. Get immediate medical attention. (See Note to Physician ). Inhalation: Remove from area to fresh air. If not breathing, clear airway and start mouth-to-mouth artificial respiration or use a bag-mask respirator. Get immediate medical attention. If victim is having trouble breathing, transport to medical care and, if available, give supplemental oxygen. Page 5 of 6
Note to Physician: Probable mucosal damage may contraindicate the use of gastric lavage. Measures against circulatory shock as well as oxygen and measures to support breathing manually or mechanically may be needed. If persistent, convulsions may be controlled by the cautious intravenous injection of a short-acting barbiturate drug. Toxicity Acute Toxicity The acute oral toxicity (LD 50 ) of Hyamine 1622 in rats is 420 mg/kg. The material is essentially nontoxic dermally with a dermal LD 50 in rabbits greater than 3 g/kg. Eye irritation studies indicated that Hyamine 1622 in concentrations of 1 percent, 5 percent, and 10 percent produced progressively greater irritation manifested by varying degrees of erythema and conjuctivitis (irritation of the conjunctiva). The same concentrations produced no irritation when eyes were washed immediately after instillation. Undiluted material caused corneal opacity in the unwashed eye. On mucosal tissue of mice 0.1 percent solutions produced no irritation, but some irritation resulted from the application of a 0.2 percent solution. On the skin of rabbits and dogs, solutions of 1.0 percent caused erythema, blanching, and edema. A single application of a 0.6 percent solution was non irritating to the skin of dogs. In rabbits, a 100% active powder applied to the skin was a severe irritant. Chronic Toxicity (CTFA Review) Hyamine 1622 was administered to rats in their diets for 2 years at levels of 0, 50, 200, 1000, 2500, and 5000 ppm. At the 5000 ppm level, growth was retarded and mortality rate increased. Histopathological examination showed that the testes of male rats were atrophied at the 2500 and 5000 ppm levels. No other pathology was found and no change in appearance, behavior, hematology, or tissues was observed. Chronic dietary administration for one year to dogs at levels of 0, 5, 100, and 500 ppm produced no adverse effects on growth or survival. No hematologic or pathologic changes were noted. Packaging Hyamine 1622-50% is available in 40 lb. net weight pails and 450 lb. net weight drums. Hyamine 1622 Crystals is available in 22 lb. net weight pails and 110 lb. net weight drums. Regulatory Hyamine 1622 Hymaine 1622-50% Crystals EPA Registrartion No. 6836-91 6836-93 Canadian Pesticide Control No. 17011 -- Hyamine 1622 is permitted by the FDA for use as an indirect food additive for adhesives as noted in 21 CFR 175.105. Colipa Use as a preservative at levels up to 0.1% Colipa No.: P70 EEC No.: Annex 11. No. 415 For information on Lonza s extensive portfolio of EPA registered formulations and our Supplemental Registration Program, please call our Technical Service Hotline at 800-365-TECH (8324) or contact us at contact.allendale@lonza.com. Page 6 of 6