Table-Toxicology Data Requirements
Guideline Number | Data Requirements | Use Pattern | Test substance to support | Test Note No. | ||
Food | Nonfood | MP | EP | |||
Acute Testing | ||||||
870.1100 | Acute oral toxicity - rat | R | R | TGAI and MP | TGAI, EP, and possibly diluted EP | 1, 2 |
870.1200 | Acute dermal toxicity | R | R | TGAI and MP | TGAI, EP | 1, 2, 3 |
870.1300 | Acute inhalation toxicity - rat | R | R | TGAI and MP | TGAI and EP | 4 |
870.2400 | Primary eye irritation - rabbit | R | R | TGAI and MP | TGAI and EP | 3 |
870.2500 | Primary dermal irritation | R | R | TGAI and MP | TGAI and EP | 1, 3 |
870.2600 | Dermal sensitization | R | R | TGAI and MP | TGAI and EP | 3, 5 |
870.6100 | Delayed neurotoxicity (acute) - hen | CR | CR | TGAI | TGAI | 6 |
870.6200 | Acute neurotoxicity - rat | R | R | TGAI | TGAI | 7 |
Subchronic Testing | ||||||
870.3100 | 90-day Oral - rodent | R | CR | TGAI | TGAI | 8, 9 |
870.3150 | 90-day Oral - non-rodent | R | CR | TGAI | TGAI | 36 |
870.3200 | 21/28-day Dermal | R | NR | TGAI | TGAI and EP | 10, 11 |
870.3250 | 90-day Dermal | CR | R | TGAI | TGAI and EP | 11, 12 |
870.3465 | 90-day Inhalation - rat | CR | CR | TGAI | TGAI | 13, 14 |
870.6100 | 28-day Delayed neurotoxicity-hen | CR | CR | TGAI | TGAI | 6, 15 |
870.6200 | 90-day Neurotoxicity - rat | R | R | TGAI | TGAI | 7, 16 |
Chronic Testing | ||||||
870.4100 | Chronic oral - rodent | R | CR | TGAI | TGAI | 17, 18, 19 |
870.4200 | Carcinogenicity - two rodent species - rat and mouse preferred | R | CR | TGAI | TGAI | 9, 17, 18, 19, 20, 21 |
Developmental Toxicity and Reproduction | ||||||
870.3700 | Prenatal Developmental toxicity - rat and rabbit, preferred | R | R | TGAI | TGAI | 22, 23, 24, 25, 26 |
870.3800 | Reproduction and fertility effects | R | R | TGAI | TGAI | 26, 27, 29 |
870.6300 | Developmental neurotoxicity | CR | CR | TGAI | TGAI | 27, 28, 29 |
Mutagenicity Testing | ||||||
870.5100 | Bacterial reverse mutation assay | R | R | TGAI | TGAI | 30 |
870.5300 870.5375 | In vitro mammalian cell assay | R | R | TGAI | TGAI | 30, 31 |
870.5385 870.5395 | In vivo cytogenetics | R | R | TGAI | TGAI | 30, 32 |
Special Testing | ||||||
870.7485 | Metabolism and pharmacokinetics | R | CR | PAI or PAIRA | PAI or PAIRA | 33 |
870.7200 | Companion animal safety | CR | CR | NR | TGAI or EP | 34 |
870.7600 | Dermal penetration | CR | CR | Choice | Choice | 35 |
870.7800 | Immunotoxicity | R | R | TGAI | TGAI |
40 C.F.R. §158.500