Title 40
SECTION 158.310
158.310 Product chemistry data requirements table.
§ 158.310 Product chemistry data requirements table.(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
| Guideline Number | Data Requirement | Use Pattern | Test substance to support | Test Note No. | |
|---|---|---|---|---|---|
| All | MP | EP | |||
| Product Identity and Composition | |||||
| 830.1550 | Product identity and composition | R | MP | EP | 1 |
| 830.1600 | Description of materials used to produce the product | R | MP | EP | 2 |
| 830.1620 | Description of production process | R | MP | EP | 3 |
| 830.1650 | Description of formulation process | R | MP | EP | 4 |
| 830.1670 | Discussion of formulation of impurities | R | MP, and possibly TGAI | EP, and possibly TGAI | 5 |
| 830.1700 | Preliminary analysis | CR | MP, and possibly TGAI | EP, and possibly TGAI | 6, 9, 10 |
| 830.1750 | Certified limits | R | MP | EP | 7 |
| 830.1800 | Enforcement analytical method | R | MP | EP | 8 |
| 830.1900 | Submittal of samples | CR | MP, PAI and TGAI | EP, PAI, TGAI | 9, 11 |
| 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 normal and elevated temperatures, metals, and metal ions | R | MP and TGAI | EP | 9, 12, 26 |
| 830.6314 | Oxidation/reduction: chemical incompatibility | CR | MP | EP | 13 |
| 830.6315 | Flammability | CR | MP | EP | 14 |
| 830.6316 | Explodability | CR | MP | EP | 15 |
| 830.6317 | Storage stability | R | MP | EP | |
| 830.6319 | Miscibility | CR | MP | EP | 16 |
| 830.6320 | Corrosion characteristics | R | MP | EP | |
| 830.6321 | Dielectric breakdown voltage | CR | NR | EP | 17 |
| 830.7000 | pH | CR | MP and TGAI | EP and TGAI | 9, 18 |
| 830.7050 | UV/visible light absorption | R | TGAI or PAI | NR | - |
| 830.7100 | Viscosity | CR | MP | EP | 19 |
| 830.7200 | Melting point/melting range | R | TGAI or PAI | TGAI or PAI | 9, 20 |
| 830.7220 | Boiling point/boiling range | R | TGAI or PAI | TGAI or PA | 9, 21 |
| 830.7300 | Density/relative density/bulk density | R | MP and TGAI | EP and TGAI | 9 |
| 830.7370 | Dissociation constants in water | R | TGAI or PAI | TGAI or PAI | 9, 22 |
| 830.7520 | Particle size, fiber length, and diameter distribution | CR | TGAI or PAI | EP | 23 |
| 830.7550 830.7560 830.7570 |
Partition coefficient (n-octanol/water) | R | TGAI or PAI | TGAI or PAI | 24 |
| 830.7840 830.7860 |
Water solubility | R | TGAI or PAI | TGAI or PAI | 9 |
| 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 § 158.320.
2. Data must be provided in accordance with § 158.325.
3. Data must be provided in accordance with § 158.330.
4. Data must be provided in accordance with § 158.335.
5. Data must be provided in accordance with § 158.340.
6. Data must be provided in accordance with § 158.345.
7. Data must be provided in accordance with § 158.350.
8. Data must be provided in accordance with § 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 µm.
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 °C (122 °F) during production or storage.