161.102—Distinguishing between what data are required and what substance is to be tested.
(a)
Readers should be careful to distinguish between what data are required and what substance is to be tested, as specified in this part and in each corresponding section of the guidelines. Each data requirement table specifies whether a particular data requirement is required to support the registration of manufacturing-use products, end-use products, or both. The test substance column specifies which substance is to be subjected to testing. Thus, the data from a certain kind of study may be required to support the registration of each end-use product, but the test substance column may state that the particular test shall be performed using, for example, the technical grade of the active ingredient(s) in the end-use product.
(b)
Manufacturing-use products (MP) and end-use products (EP) containing a single active ingredient and no inert ingredients are identical in composition to each other and to the technical grade of the active ingredient (TGAI) from which they were derived, and therefore, the data from a test conducted using any one of these as the test substance (e.g., TGAI) is also suitable to meet the requirement (if any) for the same test to be conducted using either of the other substances (i.e., MP or EP).