OECD Guidelines for the Testing of Chemicals, Section 4

Health Effects

2074-5788 (online)
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The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. 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.

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Test No. 478: Genetic Toxicology: Rodent Dominant Lethal Test

Test No. 478: Genetic Toxicology: Rodent Dominant Lethal Test You or your institution have access to this content


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Dominant lethal (DL) effects cause embryonic or foetal death. Induction of a dominant lethal event after exposure to a test substance (liquid, solid, vapour or gas, …) indicates that the substance has affected germinal tissue of the test species. Dominant lethals are generally accepted to be the result of chromosomal aberrations (structural and numerical anomalies), but gene mutations and toxic effects cannot be excluded.

This Test Guideline recommends rats or mice as the test species. Generally, male animals are exposed to the test substance and mated to untreated virgin females. The most widely used is the single administration of the test substance by oral or by intraperitoneal injection. Normally, three dose levels should be used. The various germ cell stages can be tested separately by the use of sequential mating intervals. The females are sacrificed after an appropriate period of time, and the contents of the uteri are examined to determine the numbers of implants and live and dead embryos. The calculation of the dominant lethal effect is based on comparison of the live implants per female in the treated group to the live implants per female in the control group.

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