(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (f) of the section.
(b) Use patterns. Product chemistry data are required for all pesticide products and are not use-specific.
(c) Test substance. Data requirements that list only the manufacturing-use product as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added.
(d) Key. R=Required; CR=Conditionally required; MP=Manufacturing-use product; NR=Not required; EP=End-use product; TGAI=Technical grade of the active ingredient; PAI=Pure active ingredient.
(e) Table. The following table shows the data requirements for product chemistry. The table notes are shown in paragraph (f) of this section.
Product Chemistry Data Requirements----------------------------------------------------------------------------------------------------------------
Use Pattern Test substance to support
Guideline Number Data Requirement -------------------------------------------------- Test Note
All MP EP No.----------------------------------------------------------------------------------------------------------------Product Identity and Composition................................................................................----------------------------------------------------------------------------------------------------------------
830.1550 Product identity R MP EP 1
and composition----------------------------------------------------------------------------------------------------------------
830.1600 Description of R MP EP 2
materials used
to produce the
product----------------------------------------------------------------------------------------------------------------
830.1620 Description of R MP EP 3
production
process----------------------------------------------------------------------------------------------------------------
830.1650 Description of R MP EP 4
formulation
process----------------------------------------------------------------------------------------------------------------
830.1670 Discussion of R MP, and possibly EP, and possibly 5
formulation of TGAI TGAI
impurities----------------------------------------------------------------------------------------------------------------
830.1700 Preliminary CR MP, and possibly EP, and possibly 6, 9, 10
analysis TGAI TGAI----------------------------------------------------------------------------------------------------------------
830.1750 Certified limits R MP EP 7----------------------------------------------------------------------------------------------------------------
830.1800 Enforcement R MP EP 8
analytical
method----------------------------------------------------------------------------------------------------------------
830.1900 Submittal of CR MP, PAI and TGAI EP, PAI, TGAI 9, 11
samples----------------------------------------------------------------------------------------------------------------Physical and Chemical Properties................................................................................----------------------------------------------------------------------------------------------------------------
830.6302 Color R MP and TGAI EP 9----------------------------------------------------------------------------------------------------------------
830.6303 Physical state R MP and TGAI EP and TGAI 9----------------------------------------------------------------------------------------------------------------
830.6304 Odor R MP and TGAI EP 9----------------------------------------------------------------------------------------------------------------
830.6313 Stability to R MP and TGAI EP 9, 12, 26
normal and
elevated
temperatures,
metals, and
metal ions----------------------------------------------------------------------------------------------------------------
830.6314 Oxidation/ CR MP EP 13
reduction:
chemical
incompatibility----------------------------------------------------------------------------------------------------------------
830.6315 Flammability CR MP EP 14----------------------------------------------------------------------------------------------------------------
830.6316 Explodability CR MP EP 15----------------------------------------------------------------------------------------------------------------
830.6317 Storage R MP EP
stability----------------------------------------------------------------------------------------------------------------
830.6319 Miscibility CR MP EP 16----------------------------------------------------------------------------------------------------------------
830.6320 Corrosion R MP EP
characteristics----------------------------------------------------------------------------------------------------------------
830.6321 Dielectric CR NR EP 17
breakdown
voltage----------------------------------------------------------------------------------------------------------------
830.7000 pH CR MP and TGAI EP and TGAI 9, 18----------------------------------------------------------------------------------------------------------------
830.7050 UV/visible light R TGAI or PAI NR --
absorption----------------------------------------------------------------------------------------------------------------
830.7100 Viscosity CR MP EP 19----------------------------------------------------------------------------------------------------------------
830.7200 Melting point/ R TGAI or PAI TGAI or PAI 9, 20
melting range----------------------------------------------------------------------------------------------------------------
830.7220 Boiling point/ R TGAI or PAI TGAI or PA 9, 21
boiling range----------------------------------------------------------------------------------------------------------------
830.7300 Density/relative R MP and TGAI EP and TGAI 9
density/bulk
density----------------------------------------------------------------------------------------------------------------
830.7370 Dissociation R TGAI or PAI TGAI or PAI 9, 22
constants in
water----------------------------------------------------------------------------------------------------------------
830.7520 Particle size, CR TGAI or PAI EP 23
fiber length,
and diameter
distribution----------------------------------------------------------------------------------------------------------------
830.7550 Partition R TGAI or PAI TGAI or PAI 24
830.7560.................... coefficient (n-
830.7570.................... octanol/water)----------------------------------------------------------------------------------------------------------------
830.7840 Water solubility R TGAI or PAI TGAI or PAI 9
830.7860....................----------------------------------------------------------------------------------------------------------------
830.7950 Vapor pressure R TGAI or PAI TGAI or PAI 9, 25----------------------------------------------------------------------------------------------------------------
(f) Test notes. The following test notes are applicable to the product chemistry data requirements in the table to paragraph (e) of this section:
1. Data must be provided in accordance with Sec. 158.320.
2. Data must be provided in accordance with Sec. 158.325.
3. Data must be provided in accordance with Sec. 158.330.
4. Data must be provided in accordance with Sec. 158.335.
5. Data must be provided in accordance with Sec. 158.340.
6. Data must be provided in accordance with Sec. 158.345.
7. Data must be provided in accordance with Sec. 158.350.
8. Data must be provided in accordance with Sec. 158.355.
9. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI.
10. Data are required if the product is produced by an integrated system.
11. Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.
12. Data on the stability to metals and metal ions are required only if the TGAI is expected to come into contact with either material.
13. Required when the product contains an oxidizing or reducing agent.
14. Required when the product contains combustible liquids.
15. Required when the product is potentially explosive.
16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent.
17. Required when the EP is a liquid and is to be used around electrical equipment.
18. Required when the test substance is soluble or dispersible in water.
19. Required when the product is a liquid.
20. Required when the TGAI is solid at room temperature.
21. Required when the TGAI is liquid at room temperature.
22. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
23. Required for water insoluble test substances (10-6 g/l) and fibrous test substances with diameter of =0.1 [micro]m.
24. Required if technical chemical is organic and non-polar.
25. Not required for salts.
26. Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required if the TGAI is expected to be subjected to temperatures 50 [deg]C (122 [deg]F) during production or storage.