TECHNICAL REPORT
DESCRIPTION - PROFESSIONAL AMPHYL? BRAND DISINFECTANT CLEANER is a concentrated, multipurpose, disinfectant detergent with hospital antimicrobial activity including Tuberculocidal efficacy. ACTIVE INGREDIENTS:
o-Phenylphenol ………………………………..…………………………….… 10.5% o-Benzyl-p-chlorophenol …………………………………..………………….. 5.0%
INERT INGREDIENTS: *
………………………..………………………………………………………….. 84.5%
* Includes detergents, and contains no phosphates. EPA REG. NO. 675-43 EPA EST NO. 09019-OH-002
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: Prepare a fresh solution daily and change solution frequently if soiled or diluted. Always remove filth and heavy soil prior to use. Profe ssional AMPHYL® Brand Disinfectant Cleaner has been tested and found effective in the presence of organic matter. Product solution is in concentrated form; dilute only according to directions, following precautions indicated on the label. Thoroughly preclean heavily soiled surfaces with Professional AMPHYL® Brand Disinfectant Cleaner prior to disinfecting. NOTE: Prepare fresh Professional AMPHYL® Brand Disinfectant Cleaner solution for each use. If a freshly prepared ½% Professional AMPHYL® Brand Disinfectant Cleaner solution is not to be utilized immediately, add 2 oz. of isopropyl alcohol to each quart of product solution to maintain clarity. To prepare a proper dilution in required quantities, add full strength Professional AMPHYL® Brand Disinfectant Cleaner to water as below. CORRECT DILUTION STRENGTH
PROFESSIONAL AMPHYL® BRAND DISINFECTANT CLEANER
WATER
½% (1:200)
5cc (1 tsp.) 20cc (4 tsp.) 40 cc (1&1/3 oz.)
1 quart 1 gallon 2 gallons
(One tablespoonful equals about ½ fluid oz. or 15cc)
FOR GENERAL CLEANING: Use ½% solution for lightly soiled areas and 1% solution for more difficult soil conditions. FOR GENERAL DISINFECTION: (Including tuberculocidal effectiveness). When required, remove heavy soil and gross filth prior to disinfection, as per above cleaning instructions. Floors, walls and environmental surfaces should be mopped, wiped or scrubbed with the recommended solution (1:200), maintaining a thoroughly wet surface for 10 minutes and allowed to air dry. Discard used solution daily or more often if soiling is evident. Professional AMPHYL® Brand Disinfectant Cleaner is effective in 10 minutes at 20ºC (68ºF).
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MICROBIOLOGY DATA GERMICIDAL ACTIVITY Mechanism of Action for Disinfectant Antimicrobial Agents
Test Method: Use-Dilution method as described by Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC).
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.
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.
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 cross-linked 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.
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 30 minutes at 37ºC. This now represents a nonporous, hard, inanimate surface contaminated with a dried film of bacteria. The contaminated carriers are exposed to 10 ml of the diluted germicide for 10 minutes at 20ºC. After treatment; the carriers are removed from the disinfectant and placed in 10 ml subculture broth media containing appropriate neutralizers. The subculture tubes are incubated 48-54 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 60 out of 60 carriers tested against S. aureus, S. choleraesuis and P. aeruginosa. For additional organisms, all the bacteria on 10 out of 10 carriers tested must be killed.
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.
Test Conditions: Professional AMPHYL® Brand Disinfectant Cleaner diluted 1:200. Test culture with 5% blood serum. Contact time 10 minutes at room temperature. Test Results: Number of Carriers
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.
Test Organism Staphylococcus aureus ATCC 6538 Salmonella choleraesuis ATCC 10708 Pseudomonas aeruginosa ATCC 15442 Enterococcus (Streptococcus) faecalis Enterobacter aerogenesATCC 13048 Enterococcus faecalis ATCC 828 Escherichia coli ATCC 11229 Klebsiella pneumoniae ATCC 9997 Proteus vulgaris ATCC 9920 Serratia marcescens ATCC 8195 Shigella dysenteriae ATCC 11835 Streptococcus pyogenes Mycobacterium tuberculosis var bovis*
* See following page for methodology.
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Exposed 180 180 180 20 20 20 20 20 20 20 20 20 10
Showing Growth 0 0 0 0 0 0 0 0 0 0 0 0 0
TUBERCULOCIDAL ACTIVITY
Since no specific method is currently recommended for testing this efficacy, data that is submitted must meet certain criteria:
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 21-25 days at 37ºC. in modified Proskauer-Beck Medium. One milliliter (1 ml) of a 0.1% Tween 80 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 20% T at 650 mm on a Spectronic-20. Porcelain penicylinder carriers are soaked in this adjusted culture for 15 minutes. Each contaminated carrier is placed into 10 ml of the germicidal solution for 10 minutes at 20ºC. After the 10 minutes contact time, the carriers are removed from the germicide and placed into 10 ml of a neutralizer for 10 minutes. The carriers are then removed from the neutralizer and placed into 20 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 60 days at 37ºC. If no growth is observed at the end of 60 days, the tubes are incubated an additional 30 days. An effective tuberculocidal agent kills all the organisms on all the carriers tested.
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 104.
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.
Test Conditions: Professional AMPHYL® Brand Disinfectant Cleaner diluted 1:200. Test culture with 5% blood serum. Test Results: Mycobacterium tuberculosis var bovis (BCG) Number Tubes + Number of Rings Tested 10
Proskauer-Beck Middlebrook
0
0
Kirchner
Test Conditions: Professional AMPHYL® Brand Disinfectant Cleaner with the soil load incorporated in the test as specified below for each virus.
0
Test Results: Test Virus HIV-1 (AIDS Virus) Herpes Simplex Type 1
VIRUCIDAL ACTIVITY Test Method: Virucidal activity -test method as described in the EPA Guidelines for Registering Pesticides, Federal Register 40 (123) 26836, 6/25/75.
Influenza A2 (Hong Kong) Vaccinia
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.
Host MT2 Baby Swiss albino mice Chick embryo W138
% Inactivation >99.9 >99.9 >99.9 >99.9
All viruses treated with Professional AMPHYL® Brand Disinfectant Cleaner were completely inactivated. Complete inactivation indicated at least three logs of virus were inactivated with no residual virus detected within 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
FUNGICIDAL ACTIVITY
FUNGISTATIC ACTIVITY
Test Method: Use-Dilution Method as described by the Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC).
Procedure: Hard Surface Mildew Fungistatic Test – as described in the Federal Register, “Environmental Protection Agency Guidelines for Registering Pesticides”, June 25, 1975, Vol. 40 No. 123, P. 26851.
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.
Test Conditions: Professional AMPHYL® Brand Disinfectant Cleaner. Test culture with 5% blood serum. Contact time as specified. Test Results: Untreated Control Tiles Tile 7 Days 1 ++++ 2 ++++ 3 ++++ 4 ++++ 5 ++++ 6 ++++ 7 ++++ 8 ++++ 9 ++++ 10 ++++
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 7-10 day old agar plates or slants. The contaminated carriers are then removed and dried for approximately 30 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 10 ml of the diluted germicide for 10 minutes at 20ºC. After treatment, the carriers are placed in 10 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 10 out of 10 carriers tested.
0 – No Growth ++++ - Excessive Growth PHYSICAL DATA
Test Conditions: Professional AMPHYL® Brand Disinfectant Cleaner diluted at 1:200. Test culture with 5% blood serum. Contact time as specified.
CHARACTERISTIC Appearance Odor pH, Concentrate @ 25ºC PH, 1:200 dilution Density/Specific Gravity @ 25ºC Flash Point Weight / Gallon, lbs. Detergent Type Phosphates, % as P Shelf Life Stability (Freeze/Thaw)
Test Results: Test Organism Candida Albicans Trichophyton mentagrophytes
Aspergillus niger ATCC 6275 Tiles treated with Professional AMPHYL® Brand Disinfectant Cleaner Tile 7 Days 30 Days 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 0 9 0 0 10 0 0
Number of Carriers Exposed Showing Growth 20 0 20 0
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PHYSICAL PROPERTY / TEST RESULT Clear dark red liquid Juniper / Pine needle 10.5 9.5 1.11 147ºF (Tag Closed Cup) 8.5 Anionic None +2 years Pass 3 Cycles
OTHER INFORMATION
HMIS HAZARD RATING - CONCENTRATE
Conductive Floors:
Health Flammability Reactivity
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 25,000 – 1,000,000 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 Disinfectant Cleaner has no effect on the resistant properties of conductive flooring as per the requirements of the National Fire Protection Association, NFPA-99-1993, Chapter 12, Section 124.1.3.8. Test results are available upon request.
3 0 0
Serious Minimal Minimal
NFPA HAZARD RATING - CONCENTRATE Health Fire Reactivity
3 0 0
High Negligible Negligible
HMIS HAZARD RATING – DILUTED 1:200 Health Flammability Reactivity
0 0 0
Minimal Minimal Minimal
NFPA HAZARD RATING – DILUTED 1:200 Health Fire Reactivity
0 0 0
Negligible Negligible Negligible
HMIS – Hazardous Material Identification System NFPA – National Fire Protection Association
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PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS AND DOMESTIC ANIMALS: For Concentrate: KEEP OUT OF REACH OF CHILDREN DANGER:
Corrosive. Causes eye damage and skin irritation. Do not get in eyes, on skin, or on clothing. Wear goggles or face shield and rubber gloves when handling. Avoid contamination of food.
FIRST AID:
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. If swallowed, do not induce vomiting. Drink a large amount of water. Call a physician.
NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage. Measures against circulatory shock, respiratory depression and convulsion may be needed. PHYSICAL OR CHEMICAL HAZARD: Do not use or store near heat or open flame.
For 1:200 Dilution: CAUTION: KEEP OUT OF THE REACH OF CHILDREN
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. MORE INFORMATION: NOTICE: This product contains an ingredient known to the state of California to cause cancer. 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 1-800-677-9218
VISIT US AT: www.reckittprofessional.com
DISTRIBUTED BY: RECKITT BENCKISER INC. 1655 VALLEY ROAD WAYNE, NEW JERSEY 07474-0977
ORDER NO. 36241-95101
PACKAGING DESCRIPTION Professional AMPHYL® Brand Disinfectant Cleaner SIZE 1 Gallon Plastic Bottle 4 per case
©2000 Reckitt Benckiser Inc.
CASE CUBE 1.14
N-1667-0801 7
