In the preclinical assessment and evaluation of the toxic characteristics of a substance, the determination of acute toxicity is usually the first step. It can provide data on health hazards likely to arise from a short term exposure.
This data from an acute study may also serve as a basis for product labelling or hazard classification.
These tests are also an initial step in establishing dosing schedules for subchronic and other long term studies and may provide initial information on the types of toxicities seen.
Acute Toxicity Studies
Acute Toxicity Studies precede sub-chronic toxicity studies and can range from:
- for 14 days or up to 28 days in mice or rats by most routes.
Subacute Toxicity Studies
In the assessment of the toxic characteristics of a pharmaceutical or chemical, the determination of Subacute Toxicity using repeated dosing is carried out after information on the toxicity from acute testing has been obtained.
This provides information on the possible health hazards or toxicities which may arise from repeated exposure, over a relatively short period of time (eg 1 month).
Subacute Toxicity tests are also undertaken as preliminary testing to longer term toxicity studies.
The duration of exposure should normally be 28 days, although a 14-day study may be appropriate in certain circumstances.
Subacute Toxicity Studies precede chronic toxicity studies and can range from:
- for 14 days or up to 28 days in mice or rats by most routes.