40 CFR 160.120 - Protocol.
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(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain but shall not necessarily be limited to the following information:
(2) Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number.
(3) The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted.
(6) Where applicable, the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
(9) Where applicable, a description and/or identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test, control, or reference substances before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
(11) Each dosage level, expressed in milligrams per kilogram of body or test system weight or other appropriate units, of the test, control, or reference substance to be administered and the method and frequency of administration.
(14) The date of approval of the protocol by the sponsor and the dated signature of the study director.
Title 40 published on 2014-07-01
no entries appear in the Federal Register after this date.