United States Prevention, Pesticides EPA712-C-95-027
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Product Properties
Test Guidelines
OPPTS 830.6319
Miscibility
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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 document 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 available 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 830.6319 Miscibility.
(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 63-19 Miscibility (Pes-
ticide Assessment Guidelines, Subdivision D: Product Chemistry, EPA Re-
port 540/9-82-018, October 1982) and 40 CFR 158.190 Physical and
chemical characteristics.
(b) Test Method—(1) Objective. Data on the physical and chemical
characteristics of pesticide products are used to confirm or provide sup-
portive information on their identity. Such data are also used in reviewing
the production or formulating process to produce the pesticide or product.
This test is intended to determine whether a pesticide solution is suitable
for application after dilution with oil or other nonpolar solvents, where
applicable, instead of water. Data on miscibility also provide necessary
information to support acceptable labeling for tank mix and spray applica-
tions (if the tank mix of the pesticide product is oil based or diluted with
oil).
(2) Test details, (i) For miscibility, the Agency recommends the
method described in "MT 23 Miscibility with Hydrocarbon Oil," of the
CIPAC Handbook (see paragraph (d) of this guideline), with the exception
that the test be conducted at 20 °C or 25 °C and observations be made
after 30 minutes rather than 30 °C and 1 hour as specified in the CIPAC
method. If an alternative method is used, it is recommended that the reg-
istrant consult with the Agency prior to adopting the test method.
(ii) The evaluation of miscibility of emulsifiable liquid products bear-
ing directions for dilution with nonpolar solvents shall be made at 20 °C
or 25 °C.
(iii) The product shall be mixed with nonpolar solvents whose com-
position reflects those of the label and at the rate specified on the label.
After the mixture has stood for 30 minutes, it shall be examined for separa-
tion.
(c) Reporting. (1) At the end of 30 minutes, report whether the solu-
tion is homogeneous, there has been any separation of solid matter, or
any separation into layers.
(2) Any methods used to characterize the physical properties of a
pesticide shall be referenced or described in the application for registration.
If the methods used are listed in paragraph (d) of this guideline, reference
to the methods will suffice. If other methods are used, copies of such
methods must be submitted with the application
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(3) References denoting "CIPAC" refer to standardized methods of
the Collaborative International Pesticide Analytical Council, Ltd., Hatching
Green, Harpenden, Hertfordshire, England.
(4) The applicant shall submit his own statistical evaluations of the
precision of these measurements (e.g., standard deviations or confidence
intervals) when appropriate.
(d) References. The following references should be consulted for ad-
ditional background material on this test guideline.
(1) Collaborative International Pesticide Analytical Council, Ltd.
(CIPAC) Handbook, "MT 23 Miscibility with Hydrocarbon Oil," CIPAC,
Hatching Green, Harpenden, Hertfordshire, England (1970).
(2) [Reserved]
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