Ebook: Subchronic inhalation toxicity : 90-day study

This revised Test Guideline has been designed to fully characterize test article toxicity by the inhalation route for a subchronic duration (90 days), and to provide robust data for quantitative inhalation risk assessments. Groups of 10 male and 10 female rodents are exposed 6 hours per day during a 90 day (13 week) period to a) the test article at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are always tested, but they may be exposed at different concentration levels if it is known that one sex is more susceptible to a given test article. The results of the study include measurement and daily and detailed observations (haematology and clinical chemistry), as well as ophthalmology, gross pathology, organ weights, and histopathology. This Test Guideline allows the flexibility to include satellite (reversibility) groups, interim sacrifices, bronchoalveolar lavage (BAL), neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test article.  Read more...