United States Prevention, Pesticides EPA712-C-02-026
Environmental Protection and Toxic Substances June 2002
Agency (7101)
&EPA Product Properties
Test Guidelines
OPPTS 830.6317
Storage Stability
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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 disks or paper
copies: call (202) 512-0132. This guideline is also available electronically
in PDF (portable document format) from EPA's World Wide Web site
(http://www.epa.gov/opptsfrs/home/guidelin.htm) under the heading "In-
formation Sources/Test Methods and Models/OPPTS Harmonized Test
Guidelines."
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OPPTS 830.6317 Storage stability.
(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 OPP guideline 63-17 Storage stability
(Pesticide Assessment Guidelines, Subdivision D: Product Chemistry, EPA
Report 540/9-82-018, October 1982) and 40 CFR 158.190 Physical and
chemical characteristics.
(b) Test methods—(1) Objective, (i) Data on the physical and chem-
ical characteristics of pesticide products are used to confirm or provide
supportive information on their identity. Such data are also used in review-
ing the production or formulating process used to produce the pesticide
or product.
(ii) The objective of this test is to determine how long the product
will retain the percent active ingredient in its packaging material cor-
responding to its useful shelf life. The storage stability study provides data
on change (or lack of change) in product composition over time. If certain
ingredients decompose, other new chemicals are formed whose toxicity
and other characteristics must be considered.
(2) Test details. For storage stability, the Agency recommends the
following test:
(i) The test should be conducted with the product in its commercial
package or in smaller packages of the same construction and materials.
(ii) The concentration(s) of the active ingredient(s) in the product
shall be determined at the beginning of the test period and every 3 months
thereafter for a minimum test period of 1 year. If continued beyond 1
year, the concentration(s) of the active ingredient(s) may be determined
every 6 months thereafter. Deterioration or degradation of the product dur-
ing the test period should be determined. At the end of the test period,
the product should be examined for physical changes, such as phase sepa-
ration or "clumping," and, in particular, any changes which would inter-
fere with the usefulness or safe handling of the product if used according
to the label directions.
(iii) The data may be extrapolated beyond the test period an additional
6-12 months, according to the accuracy of the analyses, for the active
ingredient(s), by a linear extrapolation of the last two data points, (e.g.,
the 9-month and 12-month points, if the test period is 1 year). The data
should be provided in the form of a graph of the concentration(s) of active
ingredient(s) versus time which would also show the linear extrapolation
of the 9-month and 12-month points beyond 1 year.
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(iv) The test shall be conducted under either of the following condi-
tions:
(A) At 20 °C or 25 °C, and, if the package is permeable, at a relative
humidity of 50 percent.
(B) Under warehouse conditions which reflect the expected storage
conditions of the commercial product.
(C) The test parameters may be expanded to include accelerated con-
ditions, such as elevated temperature (or 40 °C-54 °C) or cold temperature
extremes (-20 °C-0 °C).
(v) The test substance should be quantitatively analyzed for active
ingredient content and changes in impurities as a result of degradation
or packaging deterioration over the test period. Results should be reported
as concentration in weight percent.
(vi) The test substance and container should be observed for any
physical changes at each test interval, recording all observations in the
raw data. All test containers should be reweighed at each of the test inter-
vals, prior to and after sampling, to monitor weight.
(vii) If an alternative method is used, it is recommended that the reg-
istrant consult with the Agency prior to adopting the test method.
(3) Combined testing. A study of the storage stability of a product
may be performed in combination with the corrosion characteristics test
described in OPPTS 830.6320.
(c) Reporting. (1) The report shall describe the duration of the test
and the conditions under which the storage stability test was conducted
(e.g., temperature, humidity).
(2) The report shall include quantitative analyses for the active ingre-
dient at the initiation of the test and at each test interval. Any degradation
or deterioration of the packaging shall also be recorded at the same test
intervals.
(3) The report shall describe any physical changes in the product dur-
ing the test period and also the consequences, if any, of such changes
for safe handling and use of the product.
(4) Any methods used to characterize the physical properties of a
pesticide be described in the application for registration and copies of such
methods must be submitted with the application.
(5) The applicant shall submit his own statistical evaluation of the
precision and accuracy of these measurements (e.g., standard deviations
or confidence intervals) when appropriate.
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