Test No. 413: Subchronic Inhalation Toxicity: 90-day Study
This revised Test Guideline 413 (TG 413) has been designed to fully characterize test
article toxicity by the inhalation route following repeated exposure for a period
of 90 days, and to provide data for quantitative inhalation risk assessments. It
was updated in 2017 to enable the testing and characterisation of effects of nanomaterials
tested.
Groups of at least 10 male and 10 female rodents are exposed 6 hours per day for 90
days to a) the test chemical 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 chemical. 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), lung burden
(LB) for particles, neurologic tests, and additional clinical pathology and histopathological
evaluations in order to better characterize the toxicity of a test chemical.
Published on June 27, 2018Also available in: French
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