Application of the Validated In Vitro Reconstructed Human Skin and Eye Models For Hazard Identification of the Chemical Mixtures

Year 2021, Volume: 10 Issue: 2, 186 - 193, 28.06.2021

Yüksel Çetin

https://doi.org/10.37989/gumussagbil.818473

Abstract

The international and national directives and legislation requires to perfom validated in vitro alternative methods to animal testing of chemicals and mixtures for predictible and precise evoluation of toxicity in human. The regulatory agencies require the hazard assessment on skin and ocular as reported by the United Nations, Globally Harmonized System (UN GHS) of Classification and Labeling of Chemicals. To address this need and investigate the usage of alternative methods, the five representative chemical mixtures were prepared in different compositions and their toxicity was evaluated using in vitro validated EpiDerm™ SCT for skin corrosion, EpiDerm™ SIT for skin irritation, and EpiOcular™ OCL for eye irritation. The tested chemical mixtures 1 and 3 were found corrosive for skin and irritant for both skin and eye. They were identified in the category 1 according to UN GHS. The tested chemical mixtures 2, 4, and 5 were found to be neither corrosive nor irritant to the skin and eye. They were identified in the UN GHS No Category. The potential usage of in vitro Reconstructed Human Epidermis and Cornea-like Epithelial as a replacement to animal testing contributed significantly to classify the ocular and skin irritation/corrosion of liquid and solid chemical mixtures and to comply with the regulatory testing requirements. This study confirm that the use of alternative assays instead of conventional in vivo animal test methods could be very reliable and accurate tool to evaluate the skin and eye irritation/corrosion for hazard identification of chemical mixtures.

Keywords

EpiDerm, EpiOcular, Eye irritation, Hazard identification, Skin irritation

Supporting Institution

The Scientific and Technological Research Council of Turkey (TUBITAK), Marmara Research Center (MRC)

Kimyasal Karışımların Tehlike Tanımlaması İçin Onaylanmış in Vitro Yapılandırılmış İnsan Deri ve Göz Modellerinin Uygulanması

Abstract

Uluslararası ve ulusal yönetmeliklere ve mevzuata göre, insanda toksisitenin güvenilir ve doğru bir şekilde belirlenmesi için doğrulanmış hayvan deneylerine alternatif in vitro yöntemlerin kullanılmasi gerekmektedir. Düzenleme kurumları deri ve oküler tehlike değerlendirmesinin Kimyasalların Sınıflandırılması ve Etiketlenmesine İlişkin Birleşmiş Billetler, Global Harmonize Sisteme (UN GHS) göre yapılmasını talep etmektedir. Bu ihtiyacı yönelik olarak, hayvan testine alternatif yöntemlerin kullanımını incelemek için beş temsili farklı içeriklerde kimyasal karışım hazırlandı ve toksisiteleri doğrulanmış in vitro EpiDerm ™ SCT deri korozyonu, EpiDerm ™ SIT deri irritasyonu ve EpiOcular ™ OCL göz irritasyonu modelleri kullanılarak belirlendi. Test edilen 1 ve 3 nolu kimyasal karışımlar, deri için korrosive ve deri ve göz her ikisi içinde irritant olarak bulunmuştur. Bu kimyasallar UN GHS’e göre Kategori 1 olarak sınıflandırılmıştır. Test edilen 2, 4 ve 5 nolu kimyasal karışımların deri ve göz için koroziv ve irritant olmadığı bulunmuştur. UN GHS'ye göre sınıflandırılmayan kategorisinde tanımlanmıştır. Yönetmeliklerde yer alan gereksinimlere göre hayvan deneylerine alternatif in vitro yeniden yapılandırılmış insan epidermis ve kornea benzeri epitel modellerin kullanımı, sıvı ve katı kimyasal karışımların deri ve göz irritasyon/korozyon potansiyelerinin sınıflandırılmasına önemli ölçüde katkıda bulunabilir. Bu çalışma, kimyasal karışımların tehlike tanımlamasında geleneksel in vivo hayvan deneyleri yerine deri ve göz için koroziv/irritant değerlendirilmesinde alternatif deneyler olarak kullanılabileceğini göstermektedir.

Keywords

Deri irritasyonu, EpiDerm, EpiOcular, Göz irritasyonu, Tehlike tanımlaması

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