Journal of Literature Pharmacy Sciences

3R Kuramına Göre Güncel Deri Duyarlılığı Testleri
Current Skin Sensitisation Tests According to 3R Approach
Büşra ESENa, Özge CEMİLOĞLU ÜLKERa
aAnkara Üniversitesi Eczacılık Fakültesi, Farmasötik Toksikoloji ABD, Ankara, TÜRKİYE
J Lit Pharm Sci. 2021;10(1):76-88
doi: 10.5336/pharmsci.2020-76135
Article Language: TR
ÖZET
Deri duyarlılığı, çeşitli hücreler ve moleküller arasında yüksek koordineli etkileşim gerektiren son derece karmaşık ve sıkı düzenlenmiş biyolojik bir süreçtir. Alerjik kontakt dermatit ile sonuçlanan deri duyarlılığı, önemli bir mesleki ve çevresel sağlık sorunudur. Duyarlılaştırma potansiyelinin ölçümü, kozmetik ve kişisel bakım ürünlerinde kullanılan bileşenlerin geliştirilmesi ve risk değerlendirmesi için temel bir adımdır ve test sonucu, bir kimyasalın alerjik kontakt dermatite neden olma potansiyelini gösterir. Son yıllarda, ürün güvenliğini sağlamak için laboratuvar hayvanlarının kullanılmadığı alternatif yöntemlere öncelik verilir. Bu yolda, 3R kuramı ile bilimsel çalışmanın kalitesinden ödün vermeden rasyonel bir strateji izlenir. Alternatif yöntemler; toksikolojik bir son noktayı belirlerken, test başına hayvan sayısını, acısını ve sıkıntısını azaltan yöntemlerin kullanımı veya yer değiştirme ile sonuçlanan yeni teknikleri içerir. Konu, amaç ve teknik açıdan uygunsa in vivo yöntemlere tercih edilebilir veya entegre biçimde kullanılabilir. Alternatif yöntemlerin entegrasyonu ile in vivo yöntemlere olan gereksinim azalır. Test edilecek kimyasal madde sayısının her geçen gün arttığı düşünülürse, alternatif yöntemlerin kullanılması duyarlılık ölçümünün optimizasyonuna katkı sağlar. Avrupa Birliği ve Güney Kore, kozmetik ve kişisel bakım ürünleri için sadece alternatif hayvan dışı testleri kabul eder. Yasal sınırlamaların ve dünya çapında artan değere sahip olmalarının bir sonucu olarak alternatif yöntemler için çeşitli ülkelerde validasyon merkezleri kurulmuştur. Bu derlemede, deri duyarlılığı testlerinde gelinen son nokta ve entegre yaklaşımlar hakkında bilgi verilmiştir.

Anahtar Kelimeler: Hayvan testi alternatifleri; deri duyarlılığı; 3R; in vitro testler; in silico yöntemler
ABSTRACT
Skin sensitisation is an extremely complex and tightly regulated biological process that requires highly coordinated interaction between various cells and molecules. Skin sensitisation resulting in allergic contact dermatitis is an important occupational and environmental health problem. Measurement of sensitisation potential is a basic step in the development and risk assessment of ingredients used in cosmetics and personal care products, and the test result shows the potential of chemical to cause allergic contact dermatitis. In recent years, alternative methods, that do not use laboratory animals to ensure product safety, have been prioritized. In this way, with the 3R theory a rational strategy without compromising the quality of scientific work is followed. While alternative methods determine a toxicological endpoint, they include new techniques that result in the use of methods that reduce the number of animals, pain and distress per test, or replacement. If subject, purpose and technically appropriate, it can be preferred to in vivo methods or used in an integrated manner. With the integration of alternative methods, the need for in vivo methods is reduced. Considering that the number of chemicals to be tested increases day by day, the use of alternative methods contributes to the optimization of sensitisation measurement. The European Union and South Korea accept only alternative non-animal tests for cosmetics and personal care products. Validation centers have been established in various countries for alternative methods as a result of legal restrictions and increasing value worldwide. In this review, information is given about the endpoint and integrated approaches in skin sensitisation tests.

Keywords: Animal testing alternatives; skin sensitisation; 3Rs; in vitro tests; in silico methods
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