OECD Guidelines for the Testing of Chemicals, Section 4

Health Effects

ISSN :
2074-5788 (online)
DOI :
10.1787/20745788
Hide / Show Abstract

The OECD Guidelines for the Testing of Chemicals is a collection of about 100 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of new and existing chemical substances, chemical preparations and chemical mixtures. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification and chemical registration. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. This group of tests covers health effects.

Also available in: French
 
Test No. 452: Chronic Toxicity Studies

Test No. 452: Chronic Toxicity Studies You or your institution have access to this content

Click to Access: 
Author(s):
OECD
Publication Date :
08 Sep 2009
Pages :
16
ISBN :
9789264071209 (PDF)
DOI :
10.1787/9789264071209-en

Hide / Show Abstract

The objective of these chronic toxicity studies is to characterize the profile of a substance in a mammalian species (primarily rodents) following prolonged and repeated exposure.
The Test Guideline focuses on rodents and oral administration. Both sexes should be used. For rodents, at least 20 animals per sex per group should normally be used at each dose level, while for non-rodents a minimum of 4 per sex per group is recommended. At least three dose levels should be used in addition to the concurrent control group. Frequency of exposure normally is daily, but may vary according to the route chosen (oral, dermal or inhalation) and should be adjusted according to the toxicokinetic profile of the test substance. The duration of the exposure period should be 12 months. The study report should include: measurements (weighing) and regular detailed observations (haematological examination, urinalysis, clinical chemistry), as well as necropsy procedures and histopathology.

Also available in: French