Immunotoxicological evaluation within toxicity studies

Aim:

The aim of this evaluation is to gain information about the effect of the test item on the immune system in the tested species. Toxicity to the immune system can be suppression (e.g. decreased host resistance to infectious agents or tumor cells) or enhancement (autoimmune diseases or hypersensitivity) of the immune response. Drug or drug-protein adducts as foreign antigen could also stimulate an anti-drug response. These evaluations are usually part of a toxicity study.

Species:

Usually two species: one rodent and one non-rodent.

Design and outcome:

As initial screen the following parameters should be taken into consideration in the standard toxicity studies:

Hematological changes (focus on changes in leucocyte counts)
Alterations in weights and/or histopathology of immune system-related organs
Changes in serum globulins (without other explanation)
Increased incidence of infections or tumors