OECD Guidelines for the Testing of Chemicals, Section 4

Health Effects

ISSN :
2074-5788 (online)
DOI :
10.1787/20745788
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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. 451: Carcinogenicity Studies

Test No. 451: Carcinogenicity Studies You or your institution have access to this content

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Author(s):
OECD
Publication Date :
08 Sep 2009
Pages :
15
ISBN :
9789264071186 (PDF)
DOI :
10.1787/9789264071186-en

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The objective of a long-term carcinogenicity study is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.

This Test Guideline is intended primarily for use with rats and mice, and for oral administration. Both sexes should be used. Each dose group and concurrent control group should contain at least 50 animals of each sex. At least three dose levels and a concurrent control should be used. Animals are dosed with the test substance daily (oral, dermal or inhalation administration) and the mode of exposure should be adjusted according to the toxicokinetic profile of the test substance. The duration of the study will normally be 24 months for rodents. For specific strains of mice, duration of 18 months may be more appropriate. Termination of the study should be considered when the number of survivors in the lower dose groups or the control group falls below 25 per cent. The results of these studies include: measurements (weighing, food consumption), and, at least, daily and detailed observations, as well as gross necropsy and histopathology.

Also available in: French