Acute toxicity study

Acute toxicity studies are aimed to evaluate adverse effects after the administration of a single dose or multiple doses of a test substance given during a period not exceeding 24 hours. Acute toxicity studies are designed to determine: 

  • the dose that will produce either mortality or serious toxicological effects; 
  • time course of drug-induced clinical observations;  
  • the doses that should be used in subsequent studies; 
  • what effects the compound has on morphology, clinical chemistry, or other parameters; 
  • the possible target organ(s) of toxicity; 
  • the estimation of safe acute doses for humans. 

Acute toxicity testing of potential new pharmaceutical products is traditionally conducted by at least two routes of administration: the intended clinical and a parenteral (IV or IP) route.  

Service details. In the standard design, acute toxicity information is obtained from appropriately conducted dose-ranging studies that define an MTD (please, see appropriate service for details), followed by the next main phase for a more detailed study of toxic effects. In typical design in the main phase, we dose one-three groups of animals with 1-3 selected doses of the test article. The number of animals in the main phase is variable, but in general, it includes 5 rodents per sex per group. A vehicle dosing group is also included. Animals are observed for mortality and signs of gross toxicity at 30 min, 2, 4, and 6 hours after the administration and thereafter daily for a period of up to 14 consecutive days. A gross necropsy is performed on all animals at the terminal sacrifice. Specific tests, such as hematological, urinary, and blood clinical chemistry analysis, food intake, histopathology, etc., in combination with more definitive toxic or gross pathology endpoints, are available on request. The inclusion of specialized endpoints based on the pharmacology of the test article is also available.  

Deliverable: A detailed study report including a full description of the study design and all experimental data. Organs and tissue samples or histological slices are also available on demand. 

Sample Submission: Dry compound or compound in a pre-made animal dosing formulation. Amounts depend on the dosing levels and the design of the study.