Experience Of Magnusson And Kligman Guinea Pigs Maximization Test In Studies Of The Sensitizing Potential Of Chemical Substances

D. Kargopoltseva(1), K. Kryshen(1), A. Katelnicova(1), Ya. Gushchin(2), M. Makarova(2), V. Makarov(1) 1-Institute of pre-clinical studies 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia; 2-Scientific-Production Organization «Houm оf Pharmacy» 188663, Leningradskiy region, Vsevolozhskiy district, Kuzmolovskiy, 3, Zavodskaya st., b. 245, Russia E-mail: kargopoltceva.dr@doclinika.ru

Abstract

Summary. According to OECD Test No: 406, the necessary research for drug registration for skin application is the study of the sensitizing potential in the Magnusson and Kligman maximization test (adjuvant test) and Bühler (non-adjuvant test). The complete Freund’s adjuvant (PAF) is used as an adjuvant in the maximization test of Magunsson and Kligman. The complete Freund’s adjuvant is nonspecifically enhances the immune response to foreign antigens and enhances the immune response in the first stage of sensitization. The Magnusson and Kligman maximization test is used in most cases in the European Union, according to literary sources. This paper describes the procedure of performed this test, as well as an analysis of the sensitizing potential of chemicals using the example of formalin and dinitrochlorobenzene, which can be used as a positive control when conducting further research. This study included 3 stages: the stage of sensitization 1 with the intradermal injection of the test articles and PAF; stages of sensitization 2 and challenge with skin applications. The concentration of test articles used for each induction exposure was well-tolerated systemically and was the highest to cause mild-to-moderate skin irritation.The concentration used for the challenge stage was the highest non-irritant dose. Evaluation of the skin reaction was performed after 48 and 72 hours after the application of the test articles on the Magnusson-Kligman scale. According to the results of the study, it was found that a more intense skin reaction was detected when using DNHB, which registered visually and microscopically.

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