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ASSESSMENT OF SENSITISING PROPERTIES ON ALBINO GUINEA PIGS: Maximisation test according to Magnusson and Klingman

OECD 406

Maximisation test according Magnusson and Kligman

 PRINCIPLE

The test animals are initially exposed to the test item by intradermal injection and epidermal application (induction phase). Following a rest period of 10 to 14 days (induction period), during which an immune response may develop, the animals are exposed to the test item at a challenge dose. The extent and degree of skin reaction to the challenge exposure in the test animals is compared with that demonstrated by control animals which undergo sham treatment during induction and receive the challenge exposure.

Observations -treated and control groups

  • Approximately 21 hours after removing the patch the challenge area is cleaned and closely-clipped and/or shaved if necessary;
  • Approximately 3 hours later (approximately 48 hours from the start of the challenge application) the skin reaction is observed and recorded according to the grades shown below;
  • Approximately 24 hours after this observation a second observation (72 hours) is made and once again recorded.

TABLE: MAGNUSSON AND KLIGMAN GRADING SCALE FOR THE EVALUATION OF CHALLENGE PATCH TEST REACTIONS

  • 0 = no visible change
  • 1 = discrete or patchy erythema
  • 2 = moderate and confluent erythema
  • 3 = intense erythema and swelling

 Interpretation of results

 The test item will be regarded as a sensitiser if 30% or more of the test animals show a sensitisation response.

 In accordance with the Regulation (EC) No 1272/2008, the test item will be classified in category 1. The signal word “Warning” and hazard statement

  • H317 “May cause an allergic skin reaction” are required.

In accordance with the Regulation (EC) No. 286/2011, the positive test item will be classified in sub-category 1A or 1B in accordance with the following table:

Criteria

Sub-category 1A

≥ 30 % responding at ≤ 0.1 % intradermal induction dose or

≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose

Sub-category 1B

≥ 30 % to < 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or

≥ 30 % responding at > 1 % intradermal induction dose

Price

€€

Turnaround

6 weeks

€ : < 1500 € €€ : between 1500 and 4000 € €€€ : between 4000 and 20000 € €€€€ : > 20000 €
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