All toxicology data, as described in paragraph (c) of this section, must be submitted to support a request for an experimental use permit.
Table-Experimental Use Permit Toxicity Data Requirements
Guideline Number | Data Requirement | Use Pattern | Test substance to support | Test Note No. | ||
Food | Nonfood | MP | EP | |||
Acute Testing | ||||||
870.1100 | Acute oral toxicity - rat | R | R | MP and TGAI | TGAI, EP | 1 |
870.1200 | Acute dermal toxicity | R | R | MP and TGAI | TGAI, EP | 1, 2 |
870.1300 | Acute inhalation toxicity - rat | R | R | MP and TGAI | TGAI and EP | 3 |
870.2400 | Primary eye irritation - rabbit | R | R | MP | TGAI and EP | 2 |
870.2500 | Primary dermal irritation | R | R | MP | TGAI and EP | 1, 2 |
870.2600 | Dermal sensitization | R | R | MP | TGAI and EP | 2, 4 |
870.6100 | Delayed neurotoxicity (acute) - hen | CR | CR | TGAI | TGAI | 5 |
Subchronic Testing | ||||||
870.3100 | 90-day Oral - rodent | R | NR | TGAI | TGAI | - |
870.3150 | 90-day Oral - non-rodent | R | NR | TGAI | TGAI | - |
Chronic Testing | ||||||
870.4100 | Chronic oral - rodent | R | NR | TGAI | TGAI | 6 |
Developmental Toxicity and Reproduction | ||||||
870.3700 | Prenatal Developmental toxicity - rat and rabbit, preferred | R | NR | TGAI | TGAI | 7, 8 |
870.3800 | Reproduction | R | NR | TGAI | TGAI | 6 |
Mutagenicity Testing | ||||||
870.5100 | Bacterial reverse mutation assay | R | NR | TGAI | TGAI | 9 |
870.5300 870.5375 | In vitro mammalian cell assay | R | NR | TGAI | TGAI | 9, 10 |
870.5385 870.5395 | In vivo cytogenetics | R | NR | TGAI | TGAI | 9, 11 |
40 C.F.R. §158.230