With many chemical classes, non-adjuvant tests (the preferred one being the Buehler test) are considered to be less sensitive.
In certain cases there may be good reasons for choosing the Buehler test involving topical application rather than the intradermal injection used in the Guinea-Pig Maximisation Test. Scientific justification should be given when the Buehler test is used.
The Guinea-Pig Maximisation Test (
GPMT
) and the Buehler test are described in this method. Other methods may be used provided that they are well-validated and scientific justification is given.
If a positive result is seen in a recognised screening test, a test substance may be designated as a potential sensitiser, and it may not be necessary to conduct a further guinea pig test. However, if a negative result is seen in such a test, the guinea pig test must be conducted using the procedure described in this tes method.
See also General introduction Part B.
1.2. DEFINITIONS
Skin sensitisation
: (allergic contact dermatitis) is an immunologically mediated cutaneous reaction to a substance. In the human, the responses may be characterised by pruritis, erythema, oedema, papules, vesicles, bullae or a combination of these. In other species the reactions may differ and only erythema and oedema may be seen.
Induction exposure
: an experimental exposure of a subject to a test substance with the intention of inducing a hypersensitive state.
Induction period
: a period of at least one week following an induction exposure during which a hypersensitive state may be developed.
Challenge exposure
: an experimental exposure of a previously treated subject to a test substance following an induction period, to determine if the subject reacts in a hypersensitive manner.
1.3. REFERENCE SUBSTANCES
The sensitivity and reliability of the experimental technique used should be assessed every six months by use of substances, which are known to have mild-to-moderate skin sensitisation properties.
In a properly conducted test, a response of at least 30 % in an adjuvant test and at least 15 % in a non-adjuvant test should be expected for mild/moderate sensitisers.
The following substances are preferred.
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