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Sanitizer Test for Inanimate Surfaces
DIS/TSS-10
EFFICACY DATA REQUIREMENTS
Supplemental Efficacy
Sanitizer Test (for inanimate, non-food contact surfaces)
(Proposed method prepared by Registration Division, Office
of Pesticide Programs, EPA, 1976)
To substantiate sanitizing claims for non-food contact surfaces (e.g.,
floors, walls, furnishings), the applicant must submit data to show that
the product, when used as directed, will substantially reduce the numbers
of test bacteria on a treated surface over those on an untreated control
surface. The following protocol may be utilized:
(a) Test requirements.
(1) Three product samples, representing 3 different preparations, one
of which is at least 60 days old, should be tested against each test bacterium
on each test surface. The test bacteria are Staphylococcusaureus
ATCC 6538 and Klebsiella pneumoniae, aberrant, ATCC 4352.
Enterobacter aerogenes (ATCC 13048 or 15038) may be substituted
for K. pneumoniae. The test surface(s) represent the type(s) of
surfaces recommended for treatment on the label including, but not limited
to, glass, metal, unglazed or glazed ceramic tile, porcelain, or vitreous
china. The propagation of cultures and use of subculture media and other
related equipment may be as specified in Sec. 4 (Disinfectants) of the
Official Methods of Analysis of the A.O.A.C., 12th ed. (1975).
(2) Determine the bacterial count in an 18- to 24-hr broth culture and
add 0.01- to 0.03-ml of the broth culture by spreading on a 1 x l-in.
square of the test surface using a bacteriological loop. If the product
is to be represented as a "one-step" cleaner-sanitizer, an appropriate
organic soil load, such as 5% blood serum, must be added to the bacterial
inoculum. The square should be dried for 40 min. in a bacteriological
incubator at 30-37C. A "zero time" bacterial numbers recovery
determination should be performed and reported to show the number of viable
bacteria on the test surface after drying. The product is applied to the
inoculated test squares as directed on the label. Parallel tests are run
on the formulation with the active ingredient(s) omitted in an identical
manner to serve as controls. If such a control solution is impractical,
use sterile distilled water to which may be added 0.01% isooctylphenoxypolyethoxyethanol
(with 9-10 moles oxyethylene, e.g., Triton X-100). After a suitable time
interval, recover the test bacteria by washing the square with adequate
agitation in appropriate media or dilution fluid containing appropriate
neutralizers. Make plate counts in appropriate nutrient agar containing
the same neutralizers by the pour or spread plate technique. Exposure
time intervals between zero time and five minutes must be tested for the
product as well as for the untreated controls.
(b) Performance requirements. The results must show a bacterial
reduction of at least 99.9% over the parallel control count within 5 minutes.
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