United States Prevention, Pesticides EPA712-C-96-322
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.3550
Acute Toxicity, Tier
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INTRODUCTION
This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing of
pesticides and toxic substances, and the development of test data that must
be submitted to the Agency for review under Federal regulations.
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has developed this guideline through a process of harmonization that
blended the testing guidance and requirements that existed in the Office
of Pollution Prevention and Toxics (OPPT) and appeared in Title 40,
Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical Information Service (NTIS) and the guidelines pub-
lished by the Organization for Economic Cooperation and Development
(OECD).
The purpose of harmonizing these guidelines into a single set of
OPPTS guidelines is to minimize variations among the testing procedures
that must be performed to meet the data requirements of the U. S. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Final Guideline Release: This guideline is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
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OPPTS 885.3550 Acute toxicity, Tier II.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136, et seq.).
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is the OPP guideline 152A-20.
(b) Purpose. Acute toxicity data provide information on health haz-
ards likely to arise from a single exposure to toxins or toxic components
derived from or associated with the test substance. The toxic components
are to be isolated and identified. The purpose of an acute toxicity study
is to determine the median lethal dose, its statistical limits, and slope using
a single exposure and a 14-day postexposure observation period.
(c) Definitions. The following definitions apply to this guideline.
Acute toxicity is the adverse effects occurring from administration of
a single dose of a component, or components, of the test substance.
Median lethal dose is a statistically derived single dose of a substance
that can be expected to cause death in 50 percent of animals. It is ex-
pressed in terms of weight of test substance per unit weight of test animal,
and also in terms of the proportion, by weight, of toxic components in
the test substance per unit weight of test animal.
(d) Principle of the test method. The test substance, including toxic
components, is administered in graduated doses to several groups of exper-
imental animals, one dose being used per group. Subsequent observations
of effects and deaths are made. Animals which die during the test are
necropsied, and at the conclusion of the test, the surviving animals are
sacrificed and necropsied as indicated by the nature of the toxic effects
observed.
(e) Substance be tested. Toxic components of the MPCA preparation
are to be isolated and identified. The test substance will comprise an ap-
propriately purified preparation of the toxic components. The proportion
by weight of toxic components in the test substance is to be determined
and reported.
(f) Test procedures—(1) Animal selection. The species and strains
of test animal to be used are those in which toxic effects were observed
in the acute toxicity/pathogenicity studies from Tier I.
(2) Route of exposure. The route or routes of exposure should cor-
respond to each and all routes (i.e. oral, dermal, and pulmonary) where
toxicity was observed in the acute toxicity/pathogenicity studies from Tier
I. A separate acute toxicity test is required for each route of exposure.
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(3) Other test standards, (i) The applicable test standards set forth
in OPPTS 885.2500, 885.2550, and 885.2600, and in OPPTS 870.1100,
870.1200, and 870.1300 should be followed.
(ii) If acute pulmonary toxicity tests are required, the applicable
standards set forth in OPPTS 885.3150 usually will take precedence over
the standards set forth in OPPTS 870.1300.
(g) Tier progression. The Agency will make recommendations on
appropriate further test requirements. In general, further test requirements
comprise appropriate tests as described for biochemical pest control agents
in this series of guidelines (OPPTS 885) or for chemical pesticides as de-
scribed in OPPTS series 870.
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