OECD Guidelines for the Testing of Chemicals, Section 4
- 2074-5788 (online)
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.
Test No. 406: Skin Sensitisation
- 17 July 1992
- 9789264070660 (PDF)
This method provides information on health hazard likely to arise from exposure to test substance via intradermical injection and/or epidermical application. In this Test Guideline, the methods preferred over other are: the Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman which uses adjuvant and the non adjuvant Buehler Test.
This Test Guideline is intended primarily for use with guinea pig, but recently mouse models for assessing sensitisation potential have been developed. For the GPMT at least 10 animals in the treatment group and 5 in the control group are used. For the Buehler test, a minimum of 20 animals is used in the treatment group and at least 10 animals in the control group. The test animals are initially exposed to the test substance. Following a rest period, the induction period (10-14 days), during which an immune response may develop, then the animals are exposed to a challenge dose. The GPMT is made during approximately 23-25 days, the Buehler test, during approximately 30-32 days. The concentration of test substance used for each induction exposure should be well-tolerated systemically and should be the highest to cause mild-to moderate skin irritation, for the challenge exposure the highest nonirritant dose should be used. All skin reactions and any unusual findings should be observed and recorded (other procedures may be carried out to clarify doubtful reactions).