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%
INERT INGREDIENTS: * o-Benzyl-p-chlorophenol …………………………………..………………….. 5.0%
………………………..………………………………………………………….. 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 PROFESSIONAL AMPHYL® WATER
DILUTION STRENGTH BRAND DISINFECTANT CLEANER
½% 5cc (1 tsp.) 1 quart
(1:200)
20cc (4 tsp.) 1 gallon
40 cc (1&1/3 oz.) 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 Test Method: Use-Dilution method as described by
Antimicrobial Agents 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 Use-Dilution Method determines disinfectant activity
The action of an antimicrobial agent on a bacterial cell for germicidal solutions. Staphylococcus aureus and
involves first adsorption to the cell surfaces, then Salmonella choleraesuis are tested to support broad-
penetration of the outer membrane to reach these target
sites. spectrum disinfectant activity claims. Germicides that are
intended for use in hospitals or other health care facilities
All bacteria contain a cell wall that is unique to this group must also be tested against Pseudomonas aeruginosa.
of organisms. The cell wall gives the cell its shape and
rigidity. It is composed of peptidoglycan which is a Additional organisms that may be clinically significant can
polymer consisting of a disaccharide repeating unit of two also be tested as an option.
different N-acetylated amino sugars, one of which is
attached to a short peptide chain. Individual glycan The Use-Dilution Method is a qualitative carrier test.
strands are cross-linked through peptide bonds between Stainless steel penicylinders are soaked for 15 minutes in
the peptide chains. Gram-negative bacteria contain an a broth culture of the test organism. The contaminated
outer cytoplasmic membrane consisting of carriers are then removed and dried for approximately 30
lipopolysaccharide (LPS) molecules that surround the cell
wall. The outer membrane is unique to Gram-negative minutes at 37ºC. This now represents a nonporous, hard,
bacteria. In addition, these organisms have an inner inanimate surface contaminated with a dried film of
cytoplasmic membrane on the inside of the cell wall, bacteria. The contaminated carriers are exposed to 10 ml
which is in contact with the cytoplasm. It consists of
phospholipids and proteins. The cytoplasmic membrane of the diluted germicide for 10 minutes at 20ºC. After
serves as the selective permeability barrier between the treatment; the carriers are removed from the disinfectant
cytoplasm and the cell environment. It is the site at which and placed in 10 ml subculture broth media containing
many of the important cellular functions occur and the
target site for many antimicrobial agents. Gram-positive appropriate neutralizers. The subculture tubes are
bacteria do not have an outer membrane, only the inner incubated 48-54 hours at 37ºC. The tubes are examined
membrane. for growth as determined by turbidity of the media. An
effective disinfectant for hospital use kills all the bacteria
Chelating agents, such as ethylenediamine tetraacetate
(EDTA), are often found in formulated disinfectants. They on 59 or 60 out of 60 carriers tested against S. aureus, S.
chelate magnesium (MG++) and calcium (C++) ions. The choleraesuis and P. aeruginosa. For additional
LPS-LPS or LPS-protein links are stabilized by Mg in the organisms, all the bacteria on 10 out of 10 carriers tested
outer membrane of Gram-negative bacteria. EDTA
destabilizes the membrane by action upon Mg++. This must be killed.
increases permeability of the cell wall.
Test Conditions: Professional AMPHYL® Brand
In high concentrations, phenolics act as a gross
protoplasmic poison, penetrating and disrupting the cell Disinfectant Cleaner diluted 1:200. Test culture with 5%
wall and precipitating the cell proteins. Phenolics are blood serum. Contact time 10 minutes at room
predominately membrane-active agents and can induce temperature.
leakage of intracellular materials from bacteria. Phenolics
have the ability to “dissolve” the lipid-rich cell wall of Test Results: Number of Carriers
Mycobacteria giving them tuberculocidal activity.
Test Organism Exposed Showing
Growth
Staphylococcus aureus ATCC 6538 180
Salmonella choleraesuis ATCC 10708 180 0
Pseudomonas aeruginosa ATCC 15442 180 0
Enterococcus (Streptococcus) faecalis 20 0
Enterobacter aerogenesATCC 13048 20 0
Enterococcus faecalis ATCC 828 20 0
Escherichia coli ATCC 11229 20 0
Klebsiella pneumoniae ATCC 9997 20 0
Proteus vulgaris ATCC 9920 20 0
Serratia marcescens ATCC 8195 20 0
Shigella dysenteriae ATCC 11835 20 0
Streptococcus pyogenes 20 0
Mycobacterium tuberculosis var bovis* 10 0
0
* See following page for methodology.
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TUBERCULOCIDAL ACTIVITY Since no specific method is currently recommended for
testing this efficacy, data that is submitted must meet
Test Method: Test method as described by Official certain criteria:
Methods of Analysis of the Association of Official
Analytical Chemists (AOAC). 1. No virus-specific cytopathic effect can be detected
in the lowest non-cytotoxic dilution or any of the
The AOAC Tuberculocidal Test uses Mycobacterium virus/disinfectant dilutions tested.
bovis (BCG) as the test organism. The organism is grown
21-25 days at 37ºC. in modified Proskauer-Beck Medium. 2. The reduction in virus titer for each of the two
One milliliter (1 ml) of a 0.1% Tween 80 solution is added batches of the test substance must be =3 logs of
to the culture which is then macerated in a sterile glass inactivation.
tissue grinder to produce a smooth cell suspension. The
culture is then adjusted with additional fresh medium to 3. The virus titer recovered from the carrier must
give 20% T at 650 mm on a Spectronic-20. Porcelain exceed 104.
penicylinder carriers are soaked in this adjusted culture
for 15 minutes. Each contaminated carrier is placed into As a result, any test of virucidal efficacy must contain
10 ml of the germicidal solution for 10 minutes at 20ºC. three basic components. The first component is the virus
After the 10 minutes contact time, the carriers are control, which quantitates the amount of virus present
removed from the germicide and placed into 10 ml of a before treatment with the disinfectant. This is done by re-
neutralizer for 10 minutes. The carriers are then removed suspending dried virus with a standard solution, e.g.
from the neutralizer and placed into 20 ml Modified tissue culture medium, and assaying in a susceptible
Proskauer-Beck Medium. Two milliliters (2 ml) of the host. The second component is the virus/disinfectant
neutralizer broth are then added to 18 ml Middlebrook treatment, which looks at how much virus is surviving
Broth and 18 ml Kirchner Medium. All the tubes are after treatment with the disinfectant. This is done by
incubated 60 days at 37ºC. If no growth is observed at treating the dried virus with the disinfectant, waiting the
the end of 60 days, the tubes are incubated an additional allotted contact time, and assaying for the presence of
30 days. An effective tuberculocidal agent kills all the residual virus in the susceptible host. The final
organisms on all the carriers tested. component is the toxicity control, which looks at the
deleterious effect of the disinfectant on the host without
Test Conditions: Professional AMPHYL® Brand any virus present. This is done by drying a solution that is
Disinfectant Cleaner diluted 1:200. Test culture with 5% identical in composition to the virus suspension, but lacks
blood serum. the virus. This dried suspension is then treated in a
manner identical to the virus/disinfectant, and then
Test Results: Mycobacterium tuberculosis var bovis assayed in the host to assess the extent of the
(BCG) deleterious effects due specifically to the disinfectant.
Number of Number Tubes + Test Conditions: Professional AMPHYL® Brand
Rings Tested Disinfectant Cleaner with the soil load incorporated in the
Proskauer-Beck Middlebrook Kirchner test as specified below for each virus.
10 00 0 Test Results:
VIRUCIDAL ACTIVITY Test Virus Host % Inactivation
HIV-1 (AIDS Virus) >99.9
Test Method: Virucidal activity -test method as described Herpes Simplex Type 1 MT2 >99.9
in the EPA Guidelines for Registering Pesticides, Federal Baby Swiss
Register 40 (123) 26836, 6/25/75. Influenza A2 (Hong Kong) >99.9
Vaccinia albino mice >99.9
In order to claim and register activity as a virucidal Chick embryo
disinfectant, the appropriate test procedures must be W138
performed. Since there are no “prototype” viruses, every
claim of activity against a specific type of virus must be All viruses treated with Professional AMPHYL® Brand
substantiated with testing against that virus. Disinfectant Cleaner were completely inactivated.
All tests for hard surface disinfectant virucidal efficacy Complete inactivation indicated at least three logs of
must be performed on a virus that has been dried onto virus were inactivated with no residual virus detected
the surface of a carrier (e.g. petri plate). within limits allowed by the toxicity of the germicide.
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FUNGICIDAL ACTIVITY FUNGISTATIC ACTIVITY
Test Method: Use-Dilution Method as described by the Procedure: Hard Surface Mildew Fungistatic Test – as
Official Methods of Analysis of the Association of Official described in the Federal Register, “Environmental
Analytical Chemists (AOAC). 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 Test Conditions: Professional AMPHYL® Brand
Salmonella choleraesuis are tested to support broad Disinfectant Cleaner. Test culture with 5% blood serum.
Contact time as specified.
spectrum disinfectant activity claims. Germicides that are
intended for use in hospitals or other health care facilities Test Results:
must also be tested against Pseudomonas aeruginosa.
Aspergillus niger ATCC 6275
This method can also be used to determine fungicidal
activity against pathogenic fungi.
Untreated Tiles treated with Professional
Control Tiles
The Use-Dilution Method is a qualitative carrier test. Tile 7 Days AMPHYL® Brand Disinfectant Cleaner
Stainless steel penicylinders are soaked for 15 minutes in 1 ++++
a yeast broth culture or mold spore suspension. 2 ++++ Tile 7 Days 30 Days
Pathogenic mold spore suspensions are made from 7-10 3 ++++
4 ++++ 10 0
day old agar plates or slants. The contaminated carriers 5 ++++
are then removed and dried for approximately 30 minutes 6 ++++ 20 0
at 37ºC. This now represents a nonporous, hard 7 ++++
8 ++++ 30 0
inanimate surface contaminated with a dried film of 9 ++++
pathogenic fungi. The contaminated carriers are exposed 10 ++++ 40 0
to 10 ml of the diluted germicide for 10 minutes at 20ºC.
50 0
After treatment, the carriers are placed in 10 ml
subculture broth media containing appropriate 60 0
neutralizers. The subculture tubes are incubated under
appropriate conditions for the test organisms. The tubes 70 0
are examined for growth as determined by turbidity of the 80 0
media. An effective disinfectant for hospital use kills all
the organisms on 10 out of 10 carriers tested. 90 0
10 0 0
0 – No Growth
++++ - Excessive Growth
PHYSICAL DATA
Test Conditions: Professional AMPHYL® Brand CHARACTERISTIC PHYSICAL PROPERTY /
Disinfectant Cleaner diluted at 1:200. Test culture with Appearance TEST RESULT
Odor
5% blood serum. Contact time as specified. pH, Concentrate @ 25ºC Clear dark red liquid
PH, 1:200 dilution Juniper / Pine needle
Test Results: Density/Specific Gravity @ 25ºC 10.5
Flash Point 9.5
Test Organism Number of Carriers Weight / Gallon, lbs. 1.11
Detergent Type 147ºF (Tag Closed Cup)
Candida Albicans Exposed Showing Phosphates, % as P 8.5
Trichophyton mentagrophytes Growth Shelf Life Anionic
Stability (Freeze/Thaw) None
20 0 +2 years
20 0 Pass 3 Cycles
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OTHER INFORMATION HMIS HAZARD RATING - CONCENTRATE
Conductive Floors: Health 3 Serious
Flammability 0 Minimal
Certain areas of a hospital or an industrial plant require
that a safe level of conductivity be maintained on the Reactivity 0 Minimal
floors. The established levels of safe conductivity are
between 25,000 – 1,000,000 ohms. Electric discharges NFPA HAZARD RATING - CONCENTRATE
must be dissipated rapidly to avoid static discharges that
might affect flammable materials, such as anesthetics. Health 3 High
Using improper disinfectants or detergents can cause a Fire 0 Negligible
residue formation which can impair conductivity. Reactivity 0 Negligible
Professional AMPHYL® Brand Disinfectant Cleaner has
no effect on the resistant properties of conductive flooring HMIS HAZARD RATING – DILUTED 1:200
as per the requirements of the National Fire Protection
Association, NFPA-99-1993, Chapter 12, Section 12- Health 0 Minimal
4.1.3.8. Test results are available upon request. Flammability 0 Minimal
Reactivity 0 Minimal
NFPA HAZARD RATING – DILUTED 1:200
Health 0 Negligible
Fire 0 Negligible
Reactivity 0 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. PACKAGING DESCRIPTION CASE CUBE
36241-95101 Professional AMPHYL® Brand Disinfectant Cleaner 1.14
SIZE
1 Gallon Plastic Bottle
4 per case
©2000 Reckitt Benckiser Inc. N-1667-0801
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