Test No. 406: Skin Sensitisation

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).

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