GLP Research Unit – Toxicity – Subchronic systemic toxicity – EN ISO 10993-11:2018

Subchronic systemic toxicity is a toxicology term that refers to a type of toxicity in which the body is exposed to low to moderate doses of a toxic substance for a period of several weeks to several months, the exposure usually lasting 90 days. It follows acute toxicity of short-term exposures and precedes long-term toxicity studies. In vivo studies, are carried out in a GLP-certified small animal facility, which ensures the highest quality of the studies conducted. For medical devices, the biocompatibility testing procedure is carried out, according to the group standard PN-EN ISO 10993-11.

Subchronic systemic toxicity studies on an in vivo model, aim to understand the effects of long-term or repeated exposure of the body to chemicals, medical devices or other toxic agents. These studies provide information on possible side effects that may occur after prolonged exposure, but may not necessarily be as severe as the effects of long-term exposure.

In Subchronic systemic toxicity studies, parameters such as body weight, clinical and behavioral changes, laboratory results (e.g., liver enzymes, indices of renal function), effects on internal organs and the immune system, and potential histopathological changes (changes in tissue structure) may be evaluated. At the end of the study, the animals undergo detailed examinations, including post-mortem evaluations and histopathological analyses of tissues. These analyses can reveal any structural changes or abnormalities caused by the substance on the in vivo model.

Subchronic systemic toxicity studies are an important part of the process of assessing the toxic risk of chemicals and evaluating the safety of consumer products, pharmaceuticals, medical devices and industrial products.

These studies provide valuable information on the adverse effects that can occur after continuous or repeated exposure to a substance, on a small animal model. They help identify potential health risks that may not be immediately apparent during acute exposure and provide insight into cumulative effects over time. In vivo subchronic toxicity studies, are part of regulatory toxicology and play a key role in assessing the safety of various products.