TECHNICAL REPORT. ACTIVE INGREDIENTS: o-phenylphenol % o-benzyl-p-chlorophenol % INERT INGREDIENTS: * %

Transcription

1 TECHNICAL REPORT DESCRIPTION - PROFESSIONAL AMPHYL? BRAND HOSPITAL BULK DISINFECTANT CLEANER is a concentrated, phenolic, disinfectant cleaner that can be diluted for broad spectrum or hospital disinfection including Tuberculocidal efficacy. Also for use as a laundry sanitizer. ACTIVE INGREDIENTS: o-phenylphenol % o-benzyl-p-chlorophenol % INERT INGREDIENTS: * % * Includes detergents, and contains no phosphates. EPA REG. NO EPA EST NO. 919-OH-1

2 DIRECTIONS FOR USE: It is a violation of Federal law to use this product in a manner inconsistent with its labeling. SAFETY REMINDER: Before employees use this or any other product, make sure they read and understand the product label, Material Safety Data Sheet and facility cleaning / disinfection protocol. FOR CLEANING AND DISINFECTING: FOR CLEANING: Apply solution to surface using a sponge or mop to wet all surfaces thoroughly. Let stand 1 minutes before wiping or allow to air dry. A fresh solution should be prepared daily or more often if solution becomes diluted or soiled. Always follow dilution recommendations found on the product label. FOR DISINFECTION: FOR MOLD AND MILDEW ON HARD NONPOROUS SURFACES Wash surfaces with Professional AMPHYL Brand Hospital Bulk Disinfectant Cleaner solution; allow to air dry. Repeat application if necessary. FOR PSEUDOMONACIDAL ACTIVITY (Use at 2% dilution-see Dilution Chart) Clean surfaces thoroughly. Apply solution using a sponge or mop. Wet surfaces thoroughly. Let stand 1 minutes before wiping or let air dry. FOR SANITIZING LAUNDRY, LINENS, BLANKETS AND DIAPERS Add 1 cup Amphyl Brand Hospital Bulk Disinfectant Cleaner to each 17 gallons of water. FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (AIDS Virus) ACTIVITY (Use at 2% dilution-see Dilution Chart) SUGGESTED AREAS OF APPLICATION FOR PROFESSIONAL AMPHYL BRAND HOSPITAL BULK DISINFECTANT CLEANER: Cleans and disinfects hard nonporous surfaces in healthcare facilities including emergency rooms, operating rooms, recovery rooms, nursing homes and dental offices. Can also be used for sanitization of washable blankets and linen. RECOMMENDED DILUTIONS AND THEIR PREPARATION: Professional Amphyl Brand Hospital Bulk Disinfectant Cleaner is supplied in concentrated form. To avoid waste and ensure efficiency, use in dilutions recommended for each purpose from the label. To make the strength solution required, add concentrated product to water in the proportions indicated below. 1% (1:1) Prof. Amphyl Hosp. Bulk Water 2% (2:1)* Prof. Amphyl Hosp. Bulk Water 3% (3:1) Prof. Amphyl Hosp. Bulk Water 1 cc 1 Quart 2 cc 1 Quart 3 cc 1 Quart 4 cc 1 Gallon 8 cc 1 Gallon 4 oz. 1 Gallon 4 oz. 3 Gallons 8 oz. 3 Gallons 12 oz. 3 Gallons 7 oz. 5 Gallons 13 oz. 5 Gallons 2 oz. 5 Gallons * This solution should be used whenever bactericidal activity against Pseudomonas aeruginosa is desired. SANITIZATION OF LAUNDRY: To each 1 pounds of blankets or linen, introduce 17 gallons of water. Add 1 cup (8 oz.) Professional Amphyl Hospital Bulk Disinfectant Cleaner. Agitate for a minimum of 3 minutes to ensure saturation. Allow to soak for 1 minutes, then add soap or detergent and wash in usual manner. 2

3 MICROBIOLOGY DATA Mechanism of Action for Disinfectant Antimicrobial Agents Generally, disinfectants destroy bacteria by attacking the cytoplasmic membranes or the cellular cytoplasm itself. The action of an antimicrobial agent on a bacterial cell involves first adsorption to the cell surfaces, then penetration of the outer membrane to reach these target sites. All bacteria contain a cell wall that is unique to this group of organisms. The cell wall gives the cell its shape and rigidity. It is composed of peptidoglycan which is a polymer consisting of a disaccharide repeating unit of two different N-acetylated amino sugars, one of which is attached to a short peptide chain. Individual glycan strands are crosslinked through peptide bonds between the peptide chains. Gram-negative bacteria contain an outer cytoplasmic membrane consisting of lipopolysaccharide (LPS) molecules that surround the cell wall. The outer membrane is unique to Gram-negative bacteria. In addition, these organisms have an inner cytoplasmic membrane on the inside of the cell wall, which is in contact with the cytoplasm. It consists of phospholipids and proteins. The cytoplasmic membrane serves as the selective permeability barrier between the cytoplasm and the cell environment. It is the site at which many of the important cellular functions occur and the target site for many antimicrobial agents. Gram-positive bacteria do not have an outer membrane, only the inner membrane. Chelating agents, such as ethylenediamine tetraacetate (EDTA), are often found in formulated disinfectants. They chelate magnesium (MG ++ ) and Calcium (C ++ ) ions. The LPS-LPS or LPS-protein links are stabilized by Mg ++ in the outer membrane of Gram-negative bacteria. EDTA destabilizes the membrane by action upon Mg ++. This increases permeability of the cell wall. In high concentrations, phenolics act as a gross protoplasmic poison, penetrating and disrupting the cell wall and precipitating the cell proteins. Phenolics are predominately membrane-active agents and can induce leakage of intracellular materials from bacteria. Phenolics have the ability to dissolve the lipid-rich cell wall of Mycobacteria giving them tuberculocidal activity. GERMICIDAL ACTIVITY Test Method: Use-Dilution method as described by Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC). The Use-Dilution Method determines disinfectant activity for germicidal solutions. Staphylococcus aureus and Salmonella choleraesuis are tested to support broadspectrum disinfectant activity claims. Germicides that are intended for use in hospitals or other health care facilities must also be tested against Pseudomonas aeruginosa. Additional organisms that may be clinically significant can also be tested as an option. The Use-Dilution Method is a qualitative carrier test. Stainless steel penicylinders are soaked for 15 minutes in a broth culture of the test organism. The contaminated carriers are then removed and dried for approximately 3 minutes at 37ºC. This now represents a nonporous, hard, inanimate surface contaminated with a dried film of bacteria. The contaminated carriers are exposed to 1 ml of the diluted germicide for 1 minutes at 2ºC. After treatment; the carriers are removed from the disinfectant and placed in 1 ml subculture broth media containing appropriate neutralizers. The subculture tubes are incubated hours at 37ºC. The tubes are examined for growth as determined by turbidity of the media. An effective disinfectant for hospital use kills all the bacteria on 59 or 6 out of 6 carriers tested against S. aureus, S. choleraesuis and P. aeruginosa. For additional organisms, all the bacteria on 1 out of 1 carriers tested must be killed. Bulk Disinfectant Cleaner. Contact time 1 minutes at room temperature. Tests against various other organisms Professional Amphyl Hospital Bulk Disinfectant Cleaner at a Use-Dilution of 1:1 except for Pseudomonas aeruginosa in which case the Use- Dilution is 2:1. # Cylinders positive out of # tested Test Organism Salmonella choleraesuis ATCC 178 Salmonella paratyphi ATCC9281 Salmonella schottmuelleri ATCC1719 Shigella dysenteriae ATCC11835 Enterobacter aerogenes ATCC1348 Escherichia coli AMC198(ATCC 11229) Proteus vulgaris ATCC 992 Pseudomonas aeruginosa ATCC 15442(2:1) Klebsiella pneumoniae ATCC 9997 Neisseria catarrhalis ATCC8176 Serratia marcescens ATCC 8195 Staphylococcus aureus 29 ATCC6538 Staphylococcus aureus 8/81 (penicillin resistant) Streptococcus pyogenes ATCC12384 Streptococcus salivarius ATCC9222 Corynebacterium diphtheriae ATCC11913 Candida albicans ATCC1231 Mycobacterium tuberculosis var bovis* * see following page for methodology 3

4 TUBERCULOCIDAL ACTIVITY Test Method: Test method as described by Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC). The AOAC Tuberculocidal Test uses Mycobacterium bovis (BCG) as the test organism. The organism is grown days at 37ºC. in modified Proskauer-Beck Medium. One milliliter (1 ml) of a.1% Tween 8 solution is added to the culture which is then macerated in a sterile glass tissue grinder to produce a smooth cell suspension. The culture is then adjusted with additional fresh medium to give 2% T at 65 mm on a Spectronic-2. Porcelain penicylinder carriers are soaked in this adjusted culture for 15 minutes. Each contaminated carrier is placed into 1 ml of the germicidal solution for 1 minutes at 2ºC. After the 1 minutes contact time, the carriers are removed from the germicide and placed into 1 ml of a neutralizer for 1 minutes. The carriers are then removed from the neutralizer and placed into 2 ml Modified Proskauer-Beck Medium. Two milliliters (2 ml) of the neutralizer broth are then added to 18 ml Middlebrook Broth and 18 ml Kirchner Medium. All the tubes are incubated 6 days at 37ºC. If no growth is observed at the end of 6 days, the tubes are incubated an additional 3 days. An effective tuberculocidal agent kills all the organisms on all the carriers tested. Bulk Disinfectant Cleaner diluted 2:1. Test Results: Mycobacterium tuberculosis var bovis (BCG) Number of Rings Tested Number Tubes + Proskauer-Beck Middlebrook Kirchner 1 VIRUCIDAL ACTIVITY Test Method: Testing sterilizers, disinfectants, sanitizers and bacteriostatic chemicals. Proceedings of the Chemical Specialties Manufacturers Association: Pages , May In order to claim and register activity as a virucidal disinfectant, the appropriate test procedures must be performed. Since there are no prototype viruses, every claim of activity against a specific type of virus must be substantiated with testing against that virus. Since no specific method is currently recommended for testing this efficacy, data that is submitted must meet certain criteria: 1. No virus-specific cytopathic effect can be detected in the lowest non-cytotoxic dilution or any of the virus/disinfectant dilutions tested. 2. The reduction in virus titer for each of the two batches of the test substance must be =3 logs of inactivation. 3. The virus titer recovered from the carrier must exceed 1 4. As a result, any test of virucidal efficacy must contain three basic components. The first component is the virus control, which quantitates the amount of virus present before treatment with the disinfectant. This is done by resuspending dried virus with a standard solution, e.g. tissue culture medium, and assaying in a susceptible host. The second component is the virus/disinfectant treatment, which looks at how much virus is surviving after treatment with the disinfectant. This is done by treating the dried virus with the disinfectant, waiting the allotted contact time, and assaying for the presence of residual virus in the susceptible host. The final component is the toxicity control, which looks at the deleterious effect of the disinfectant on the host without any virus present. This is done by drying a solution that is identical in composition to the virus suspension, but lacks the virus. This dried suspension is then treated in a manner identical to the virus/disinfectant, and then assayed in the host to assess the extent of the deleterious effects due specifically to the disinfectant. Bulk Disinfectant Cleaner diluted 1:1 with the soil load incorporated in the test as specified below for each virus. Test Results: Test Virus Host % Inactivation HIV-1 (AIDS Virus) Herpes Simplex Type 1 Influenza A2 (Hong Kong) Vaccinia MT2 Rabbit kidney Chick embryo Hela cells All viruses treated with Professional AMPHYL Brand Hospital Bulk Disinfectant Cleaner were completely inactivated. Complete inactivation indicated at least three logs of virus were inactivated with no residual virus detected with in limits allowed by the toxicity of the germicide. All tests for hard surface disinfectant virucidal efficacy must be performed on a virus that has been dried onto the surface of a carrier (e.g. petri plate). 4

5 FUNGICIDAL ACTIVITY Test Method: Use-Dilution Method as described by the Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC). The Use-Dilution Method determines disinfectant activity for germicidal solutions. Staphylococcus aureus and Salmonella choleraesuis are tested to support broad spectrum disinfectant activity claims. Germicides that are intended for use in hospitals or other health care facilities must also be tested against Pseudomonas aeruginosa. This method can also be used to determine fungicidal activity against pathogenic fungi. The Use-Dilution Method is a qualitative carrier test. Stainless steel penicylinders are soaked for 15 minutes in a yeast broth culture or mold spore suspension. Pathogenic mold spore suspensions are made from 7-1 day old agar plates or slants. The contaminated carriers are then removed and dried for approximately 3 minutes at 37ºC. This now represents a nonporous, hard inanimate surface contaminated with a dried film of pathogenic fungi. The contaminated carriers are exposed to 1 ml of the diluted germicide for 1 minutes at 2ºC. After treatment, the carriers are placed in 1 ml subculture broth media containing appropriate neutralizers. The subculture tubes are incubated under appropriate conditions for the test organisms. The tubes are examined for growth as determined by turbidity of the media. An effective disinfectant for hospital use kills all the organisms on 1 out of 1 carriers tested. Bulk Disinfectant Cleaner diluted at 1:1. Contact time as specified. Test Results: Number of Carriers Test Organism Exposed Showing Growth Candida Albicans Trichophyton me ntagrophytes 2 2 FUNGISTATIC ACTIVITY Procedure: Hard Surface Mildew Fungistatic Test as described in the Federal Register, Environmental Protection Agency Guidelines for Registering Pesticides, June 25, 1975, Vol. 4 No. 123, P Bulk Disinfectant Cleaner diluted 1:1. Contact time as specified. Test Results: Untreated Control Tiles Aspergillus niger ATCC 6275 Tiles treated with Professional AMPHYL Brand Hospital Bulk Disinfectant Cleaner Tile 7 Days Tile 7 Days 3 Days No Growth Excessive Growth PHYSICAL DATA PHYSICAL PROPERTY / CHARACTERISTIC TEST RESULT Appearance Clear amber liquid Odor Phenolic ph, 25ºC 1.5 ph, 1:1 dilution 9. Density/Specific 25ºC 1.31 Flash Point >2ºF (Tag Closed Cup) Weight / Gallon, lbs Rinsing properties Free rinsing Phosphates, % as P None Shelf Life +2 years Stability (Freeze/Thaw) Pass 3 Cycles Abrasives None 5

6 OTHER INFORMATION Conductive Floors: Certain areas of a hospital or an industrial plant require that a safe level of conductivity be maintained on the floors. The established levels of safe conductivity are between 25, 1,, ohms. Electric discharges must be dissipated rapidly to avoid static discharges that might affect flammable materials, such as anesthetics. Using improper disinfectants or detergents can cause a residue formation which can impair conductivity. Professional AMPHYL Brand Hospital Bulk Disinfectant Cleaner has no effect on the resistant properties of conductive flooring as per the requirements of the National Fire Protection Association, NFPA , Chapter 12, Section Test results are available upon request. HMIS HAZARD RATING - CONCENTRATE Health 3 Serious Flammability Minimal Reactivity Minimal NFPA HAZARD RATING - CONCENTRATE Health 3 High Fire Negligible Reactivity Negligible HMIS HAZARD RATING DILUTED 2:1 Health Minimal Flammability Minimal Reactivity Minimal NFPA HAZARD RATING DILUTED 2:1 Health Negligible Fire Negligible Reactivity Negligible HMIS Hazardous Material Identification System NFPA National Fire Protection Association 6

7 PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS AND DOMESTIC ANIMALS: For Concentrate: KEEP OUT OF REACH OF CHILDREN WARNING: FIRST AID: Harmful if swallowed. Causes eye and skin irritation. Do not get in eyes. Avoid contact with eyes and skin. Avoid contamination of food. In case of eye contact, IMMEDIATELY flush eyes thoroughly with water, remove any contact lenses, and continue to flush eyes with plenty of water for at least 15 minutes. Get medical attention. In case of skin contact, wash with soap and water. If irritation persists, consult a physician. If swallowed, drink promptly a large quantity of water to dilute the product. Get immediate medical attention. STORAGE AND DISPOSAL STORAGE: Store in original container in areas inaccessible to small children. Keep securely closed. DISPOSAL: Do not reuse empty container. Rinse thoroughly with water and detergent. Wrap and discard in trash. NOTICE: This product contains a chemical known to the state of California to cause cancer. For 2:1 Dilution: CAUTION: KEEP OUT OF THE REACH OF CHILDREN STORAGE AND DISPOSAL: Store in areas inaccessible to small children. Refill container only with Professional AMPHYL Hospital Bulk Disinfectant Cleaner. If not refilling, rinse empty container thoroughly and discard in trash. MORE INFORMATION: Satisfaction Guaranteed: Careful laboratory control assures materials of uniform quality at all times. All Reckitt Benckiser Professional products are guaranteed to give complete satisfaction, when used as directed, or they may be returned for credit. QUESTIONS? COMMENTS? CALL VISIT US AT: DISTRIBUTED BY: RECKITT BENCKISER INC VALLEY ROAD WAYNE, NEW JERSEY PACKAGING DESCRIPTION Professional AMPHYL Brand Hospital Bulk Disinfectant Cleaner ORDER NO. SIZE CASE CUBE Gallon Plastic Bottle 4 per case Reckitt Benckiser Inc. N