158.2173—Experimental use permit 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 microbial 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 pesticide toxicology. The test notes are shown in paragraph (d) of this section.
| Guideline Number | Data Requirement | All Use Patterns | Test Substance | Test Notes |
|---|---|---|---|---|
| 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 | CR | MP, EP | 5 |
(d) Test notes.
The following test notes are applicable to the data requirements for experimental use permit microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c) of this section:
1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern.
2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed.
3. Hypersensitivity incidents, including immediate type and delayed type reactions of humans or domestic animals occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur.
4. Data must be submitted only for products whose active ingredient is a virus.
5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.
6. Required when the product consists of, or under conditions of use that would result in an inhalable material (e.g., gas, volatile substances, or aerosol particulate).