Table-EUP Biochemical Pesticides Human Health Assessment Data Requirements
Guideline Number | Data Requirement | Use Patterns | Test Substance | Test Notes | ||
Food | Nonfood | MP | EP | |||
Tier I | ||||||
Acute Testing | ||||||
870.1100 | Acute oral toxicity - rat | R | R | TGAI and MP | TGAI and EP | 1 |
870.1200 | Acute dermal toxicity | R | R | TGAI and MP | TGAI and EP | 1, 2 |
870.1300 | Acute inhalation toxicity - rat | R | R | TGAI and MP | TGAI and EP | 3 |
870.2400 | Primary eye irritation - rabbit | R | R | TGAI and MP | TGAI and EP | 2 |
870.2500 | Primary dermal irritation | R | R | TGAI and MP | TGAI and EP | 1, 2 |
none | Hypersensitivity incidents | R | R | All | All | 4 |
Subchronic Testing | ||||||
870.3100 | 90-day oral (one species) | R | NR | TGAI | TGAI | - |
Developmental Toxicity | ||||||
870.3700 | Prenatal developmental - rat preferably | R | CR | TGAI | TGAI | 5 |
Mutagenicity Testing | ||||||
870.5100 | Bacterial reverse mutation test | R | CR | TGAI | TGAI | 6 |
870.5300 | In vivo mammalian cell assay | R | CR | TGAI | TGAI | 6, 7 |
Tier II | ||||||
Developmental Toxicity | ||||||
870.3700 | Prenatal developmental | CR | CR | TGAI | TGAI | 5 |
Additional mutagenicity tests that may have been performed plus a complete reference list must also be submitted. Subsequent testing may be required based on the available evidence.
40 C.F.R. §158.2083