Subacute systemic toxicity is defined as adverse events occurring between 24 hours and 28 days after multiple or continuous exposure. Subchronic systemic toxicity is defined as adverse effects occurring after repeated or continuous administration of a test sample for up to 90 days or for a period not exceeding 10 percent of the animal's lifespan.
The rationale for choosing a subacute or subchronic test is based on the medical device's duration of clinical use, the nature of exposure, and the overall testing strategy. The method of exposure in these tests is mostly extract injections and implantation. The choice of route of exposure depends on the clinical use of the device. Extract injection is often used for devices that come into contact with the body through fluids and long-term use catheters (vein and urine). This method is also useful for evaluating devices that have indirect body contact or communicate externally and are not intended for implantation.
In general, studies with exposure duration of 9-19 weeks are classified as subchronic studies and those with exposure duration longer than 60 weeks as chronic studies.
There are generally three types of toxic entities: chemical, biological, and physical. Chemicals include inorganic substances such as lead, hydrofluoric acid and chlorine gas, organic compounds such as methyl alcohol, most drugs and poisons from living things. Biological toxic entities include bacteria and viruses that cause disease in living organisms. Physical toxic entities, on the other hand, include things not generally considered under the heading toxic: direct blows, shaking, sound and vibration, non-ionizing electromagnetic radiation such as heat and cold, infrared and visible light, and ionizing radiation such as X-rays and alpha, beta and gamma radiation.
Toxicity is a measure of the degree to which a substance is toxic or poisonous. Toxicity refers to the effect on the whole organism, such as human, bacteria, or plant, or the effect on a substructure such as a cell (cytotoxicity) or organ.
Briefly, the subchronic toxicity test is used to detect the effects on a patient of a repeatedly exposed substance, including any compound toxicity effects.
Our organization also provides subchronic toxicity testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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