Policy document
June 27th 2018

Test No. 452: Chronic Toxicity Studies

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OECD
OECD
https://www.oecd.org Flag of igo IGO

The Organisation for Economic Co-operation and Development is an intergovernmental organization with 38 member countries, founded in 1961 to stimulate economic progress and world trade. It is a forum the members of which are countries describing themselves as committed to democracy and the market economy, providing a platform to compare policy experiences, seek answers to common problems, identify good practices and coordinate domestic and international policies of its members. The majority of OECD members are high-income economies with a very high Human Development Index (HDI) and are regarded as developed countries.
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.

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Identifiers

Overton ID
oecddiscovery-e7370a1ba06eb5ee949e9d6092a0e785
doi
10.1787/9789264071209-en

Topics in this document

Dose (biochemistry) Toxicology Diet (nutrition) Water Chronic toxicity Pesticide No-observed-adverse-effect level OECD Medical specialties Toxicity Clinical medicine Animal testing Solution (chemistry) Statistics Clinical endpoint Transaminase Food Dose–response relationship Tuberculosis Bioavailability Urinary bladder Autopsy Respiratory tract Health Cervix Ureter Chronic condition Drinking water Route of administration

Related SDGs

SDG 12: Responsible Consumption and Production
SDG 12: Responsible Consumption and Production

Target 12.4

Achieve the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment

Related COFOG Divisions

5: Environmental Protection 5.3: Pollution Abatement 7: Health 7.5: R&D Health

Citations

Cited by 42 other policy documents (40 of them are from other policy sources)