ABSTRACT

A description of mortality which occurred in satellite groups which were used for plasma drug determination may be included in this section if death is considered to be related to the compound and not to blood sampling procedures. Mortality caused by accidents (gavage accidents, accidents during handling or restraining of animals) should be described separately, including clinical signs preceding death and/or the evidence (e.g. necropsy findings) for classifying these deaths as accidental. Example: “Two animals [male No. 304 (40mg/kg) and female No. 605 (80 mg/kg)] were found dead on days 15 and 22, respectively. Necropsy findings in these animals (congested

gavage accident”. If a high incidence of mortality occurs in a study, and particularly if compound-related mortality occurs concurrently with mortality not related to the test compound, use a table to improve comprehensibility (see Examples 6.1 and 6.2).