§ 158.2140 Microbial pesticides toxicology data requirements table.
(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology 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 (d) of this section.
(b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:
(c) Table. The following table shows the data requirements for microbial pesticides toxicology. The test notes are shown in paragraph (d) of this section.
Table—Microbial Pesticides Toxicology Data Requirements
| Guideline Number | Data Requirement | All Use Patterns | Test Substance | Test Notes |
|---|---|---|---|---|
| Tier I | ||||
| 885.3050 | Acute oral toxicity/pathogenicity | R | TGAI | 1 |
| 885.3150 | Acute pulmonary toxicity/pathogenicity | R | TGAI | — |
| 885.3200 | Acute injection toxicity/pathogenicity/(intravenous) Acute injection toxicity/pathogenicity/(intraperitoneal) | R | TGAI | 2 |
| 885.3400 | Hypersensitivity incidents | R | All | 3 |
| 885.3500 | Cell culture | R | TGAI | 4 |
| 870.1100 | Acute oral toxicity | R | MP , EP | 1, 5 |
| 870.1200 | Acute dermal toxicity | R | MP , EP | 5 |
| 870.1300 | Acute inhalation toxicity | R | MP , EP | 5, 6 |
| 870.2400 | Acute eye irritation | R | MP , EP | 5 |
| 870.2500 | Primary dermal irritation | R | MP , EP | 5 |
| Tier II | ||||
| 885.3550 | Acute toxicology | CR | TGAI | 7 |
| 885.3600 | Subchronic toxicity/pathogenicity | CR | TGAI | 8 |
| Tier III | ||||
| 885.3650 | Reproductive fertility effects | CR | TGAI | 9, 13 |
| 870.4200 | Carcinogenicity | CR | TGAI | 10, 13 |
| 870.7800 | Immunotoxicity | CR | TGAI | 11, 13 |
| 885.3000 | Infectivity/pathogenicity analysis | CR | TGAI | 12, 13 |