Test No. 403: Acute Inhalation Toxicity

This method provides information on health hazard likely to arise from short-term exposure to a test article (gas, vapour or aerosol/particulate test article) by inhalation.

The revised Test Guideline describes two studies: a traditional LC50 protocol and a Concentration x Time (C x t) protocol. It can be used to estimate a median lethal concentration (LC50), non-lethal threshold concentration (LC01) and slope, and to identify possible sex susceptibility. This Test Guideline enables a test article quantitative risk assessment and classification according to the Globally Harmonized System for the Classification and Labelling of Chemicals. In the traditional LC50 protocol, animals are exposed to one limit concentration or to three concentrations, at least, for a predetermined duration, generally of 4 hours. Usually 10 animals should be used for each concentration. In the C x T protocol, animals are exposed to one limit concentration or a series of concentrations over multiple time durations. Usually 2 animals per C x t interval are used. Animals (the preferred species is the rat) should be observed for at least 14 days. The study includes measurements (including weighing), daily and detailed observations, as well as gross necropsy.