§ 159.165 Toxicological and ecological studies.
Adverse effects information must be submitted as follows:
(a) Toxicological studies. (1) The results of a study of the toxicity of a pesticide to humans or other non-target domestic organisms if, relative to all previously submitted studies, they show an adverse effect under any of the following conditions:
(i) That is in a different organ or tissue of the test organism.
(ii) At a lower dosage, or after a shorter exposure period, or after a shorter latency period.
(iii) At a higher incidence or frequency.
(iv) In a different species, strain, sex, or generation of test organism.
(v) By a different route of exposure.
(2) Acute oral, acute dermal, acute inhalation or skin and eye irritation studies in which the only change in toxicity is a numerical decrease in the median lethal dose (LD50), median lethal concentration (LC50) or irritation indices, are not reportable under this part unless the results indicate a more restrictive toxicity category for labeling under the criteria of 40 CFR 156.62.