Immunotoxicity studies are preclinical studies that are conducted to evaluate the potential of a substance to affect the immune system. These studies are typically conducted in laboratory animals, such as mice or rats, to assess the safety of a drug or other substance before testing in humans.
The primary objective of immunotoxicity studies is to identify any potential adverse effects of the substance on the immune system, including changes in the number, function, or composition of immune cells, as well as changes in the production of cytokines or other immune system signaling molecules. These studies can include a range of endpoints, such as immunophenotyping, histopathology, and functional assays.
Immunotoxicity studies can be further classified based on the exposure period and the endpoints evaluated:
- Acute immunotoxicity studies: These studies are conducted to evaluate the potential effects of the substance on the immune system after short-term exposure, usually for a few days to a few weeks.
- Sub-chronic immunotoxicity studies: These studies are conducted to evaluate the potential effects of the substance on the immune system after repeated exposure over a period of several weeks to several months.
- Chronic immunotoxicity studies: These studies are conducted to evaluate the potential effects of the substance on the immune system after repeated exposure over a period of several months to several years.
The results of immunotoxicity studies can help identify any potential adverse effects of the substance on the immune system, and can help inform decisions about the safety of the substance for use in humans. These studies are an important part of the preclinical safety assessment of drugs and other substances, particularly those intended for long-term use or for use in populations with compromised immune systems.