Report, BSL BIOSERVICE Study No. 112936 Version: Final
7.
Introduction
7.1.
Justification for the Selection of the Test System
page 13 of 110
This test is performed on the rat. Although several mammalian species may be used, the rat is the preferred rodent species. This study provides information on the possible health hazards which could arise from repeated exposure via oral administration to rats over a period of 14 days. As a dose range finding study, it should provide a basis for the selection of dose levels to be used in a 28-day repeated dose oral (gavage) toxicity study. The test item is administered daily in graduated doses to 3 groups of test animals, one dose level per group for a treatment period of 14 days. During the treatment period, the animals are observed each day for signs of toxicity. Animals which die or are humanely sacrificed in a condition of impending or predictable death are subjected to necropsy. At the conclusion of the test, the surviving animals are sacrificed and subjected to necropsy. 7.2.
Justification for the Selection of the Test Method No validated in vitro method is available for assessing systemic toxicity after repeated exposure.