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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 40 - Protection of Environment |
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Chapter I - Environmental Protection Agency |
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SubChapter E - Pesticide Programs |
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Part 161 - DATA REQUIREMENTS FOR REGISTRATION |
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Subpart C - Product Chemistry Data Requirements |
§ 161.190 - Physical and chemical characteristics.
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(a) Table. Sections 161.100 through 161.102 describe how to use this table to determine the physical and chemical characteristics data requirements and the substance to be tested.
Kind of data required (b) Notes All general use patterns (requirements are the same for every use pattern) Test substance Guidelines reference No. Data to support MP Data to support EP Color [R] MP and TGAI EP* and TGAI 63-2 Physical state [R] MP and TGAI EP* and TGAI 63-3 Odor [R] MP and TGAI EP* and TGAI 63-4 Melting point (1) [R] TGAI TGAI 63-5 Boiling point (2) [R] TGAI TGAI 63-6 Density, bulk density, or specific gravity [R] MP and TGAI EP* and TGAI 63-7 Solubility [R] TGAI or PAI TGAI or PAI 63-8 Vapor pressure [R] TGAI or PAI TGAI or PAI 63-9 Dissociation constant [R] TGAI or PAI TGAI or PAI 63-10 Octanol/water partition coefficient (3) [CR] PAI PAI 63-11 pH (4) [CR] MP and TGAI EP* and TGAI 63-12 Stability [R] TGAI TGAI 63-13 Oxidizing or reducing action (5) [CR] Flammability (6) [CR] MP EP* 63-15 Explodability (7) [R] MP EP* 63-16 Storage stability [R] MP EP* 63-17 Viscosity (8) [CR] MP EP* 63-18 Miscibility (9) [CR] MP EP* 63-19 Corrosion characteristics [R] MP EP* 63-20 Dielectric breakdown voltage (10) [CR] EP* 63-21 Other requirements: Submittal of samples (11) [CR] MP, TGAI, PAI EP*, TGAI, PAI 64-1 Key: R = Required; CR = Conditionally Required; [ ] = Brackets (i.e., [R],[CR]) indicate data requirements that apply when an experimental use permit is being sought; MP = Manufacturing Use Product, EP* = End Use Product; asterisk indicates those registrants that end-use applicants (i.e., formulators) need not satisfy, if their active ingredient(s) is (are) purchased from a registered source; TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient.
(b)Notes.The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Required if technical chemical is a solid at room temperature.
(2) Required if technical chemical is a liquid at room temparature.
(3) Required if technical chemical is organic and non-polar.
(4) Required if test substance is dispersible with water.
(5) Required if product contains an oxidizing or reducing agent.
(6) Required if product contains combustible liquids.
(7) Required if product is potentially explosive.
(8) Required if product is a liquid.
(9) Required if product is a emulsifiable liquid and is to be diluted with petroleum solvents.
(10) Required if end-use product is a liquid and is to be used around electrical equipment.
(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.
[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]