Table-Flagging Criteria
Study Type(s) | Guideline No. | Criteria: Treated animals show any of the following: | Criteria No. |
Carcinogenicity or combined carcinogenicity/chronic feeding study | 870.4200 870.4300 | An incidence of neoplasms in males or females which increases with dose (positive trend p[LESS THAN EQUAL TO]0.05); or | 1 |
A statistically significant (pairwise p[LESS THAN EQUAL TO]0.05) increase of any type of neoplasm in any test group, males or females at any dose level, compared to concurrent control animals of the same sex; or | 2 | ||
An increase in any type of uncommon or rare neoplasms in any test group, males or females animals at any dose level, compared to concurrent controls of the same sex; or | 3 | ||
A decrease in the time to development of any type of neoplasms in any test group, males or females at any dose level, compared to concurrent controls of the same sex. | 4 | ||
Prenatal developmental toxicity Reproduction and fertility Developmental neurotoxicity | 870.3700 870.3800 870.6300 | When compared to concurrent controls, treated offspring show a dose-related increase in malformations, pre- or post-natal deaths, or persistent functional or behavioral changes on a litter basis in the absence of significant maternal toxicity at the same dose level. | 5 |
Neurotoxicity | 870.6100 870.6200 | When compared to concurrent controls, treated animals show a statistically or biologically significant increase in neuropathological lesions or persistent functional or behavioral changes. | 6 |
Chronic feeding Carcinogenicity Reproduction and fertility Prenatal developmental toxicity Developmental neurotoxicity Acute or 90-day neurotoxicity | 870.4100 870.4200 870.3800 870.3700 870.6300 870.6200 | The no observed adverse effect level (NOAEL) from one of these studies is less than the NOAEL currently used by the Agency as the basis for either the acute or chronic reference dose. | 7 |
I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria.
I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes].
40 C.F.R. §158.34