The use of animal models for scientific purposes, particularly in the study of human anatomy and physiology, dates back to around the 6th century BC, and has been of fundamental importance in the development of essential drugs, toxicity studies, cosmetic safety testing, as well as in the diagnosis and understanding of diseases. It has significantly contributed to alleviating human suffering and acquiring new knowledge for the prevention and treatment of diseases in animals themselves. To this day, such studies are considered essential in certain contexts, such as scientific research. However, in recent decades, the scientific community has begun to question the use of animals in research, raising concerns about their welfare and the reliability of the results obtained, given the obvious morphological differences between species. These concerns are further compounded by significant ethical and moral issues. In this context, the 3Rs Principle was introduced for the first time in 1957 by Charles Hume and William Russel. Its aim is to reduce, refine, or, ideally, replace the use of animals in experimentation. The introduction of this principle initiated a new perspective in the research world, seeking to increase the development of new methodologies, such as in vitro, in chemico, and in silico techniques, designed to minimize or completely eliminate the need to use animals in experimentation.In the cosmetic field, the need for new alternative approaches to animal testing for safety evaluation, in response to the 3Rs Principle, became particularly important with the implementation of the European Cosmetics Regulation EC 1223/2009. This regulation prohibits the marketing of cosmetic ingredients and finished products tested on animals within the European Union. This thesis will therefore analyze the current directives regulating animal experimentation, with particular focus on the cosmetics industry, concentrating on the limitations of animal testing and the current alternative methodologies used in the toxicological evaluation of substances intended for the formulation of cosmetic products.
L’uso di modelli animali per scopi scientifici, in particolare nello studio dell’anatomia e della fisiologia umana, risale intorno al VI secolo a.C., ed è stato di fondamentale importanza nello sviluppo di farmaci essenziali, per studi di tossicità e test sulla sicurezza dei cosmetici e, per la diagnosi e la comprensione delle malattie, contribuendo significativamente nell’alleviamento della sofferenza umana, oltre che all’acquisizione di nuove conoscenze a favore della prevenzione e cura delle malattie degli animali stessi. Ad oggi tali studi sono considerati essenziali in determinati contesti come la ricerca scientifica. Tuttavia, negli ultimi decenni, la comunità scientifica ha incominciato a mettere in discussione l’utilizzo degli animali nella ricerca, suscitando preoccupazioni sul loro benessere e sull’attendibilità dei risultati ottenuti, considerando le evidenti differenze morfologiche tra le diverse specie. A queste criticità si aggiungono rilevanti questioni etiche-morali. In questo contesto si inserisce il Principio delle 3R, introdotto per la prima volta nel 1957 da Charles Hume e William Russel, volto a ridurre, perfezionare o, meglio ancora, sostituire l’uso di animali nella sperimentazione. L’introduzione di questo principio diede inizio ad una nuova prospettiva nel mondo della ricerca, cercando di incrementare lo sviluppo di nuove metodologie, come quelle in vitro, in chemico e in silico, volte a minimizzare o eliminare del tutto la necessità di utilizzare gli animali nelle sperimentazioni. In ambito cosmetico l’esigenza di nuovi approcci alternativi alla sperimentazione animale per la valutazione della sicurezza, al fine di rispondere al Principio delle 3R, ha assunto particolare importanza con l’entrata in vigore del Regolamento Europeo sui cosmetici UE 1223/2009, il quale vieta la commercializzazione di ingredienti cosmetici, nonché di prodotti finiti, testati su animali all’interno dell’Unione Europea. In questo elaborato di tesi verranno quindi analizzate le attuali direttive che regolamentano la sperimentazione animale con particolare attenzione all’industria cosmetica, focalizzando l’attenzione sui limiti che offre la sperimentazione animale e sulle attuali metodologie alternative usate nella valutazione tossicologica di una sostanza destinata alla formulazione di un prodotto cosmetico.
Valutazione della sicurezza dei prodotti cosmetici: modelli alternativi alla sperimentazione animale e prospettive future
MERENDA, VALENTINA
2023/2024
Abstract
The use of animal models for scientific purposes, particularly in the study of human anatomy and physiology, dates back to around the 6th century BC, and has been of fundamental importance in the development of essential drugs, toxicity studies, cosmetic safety testing, as well as in the diagnosis and understanding of diseases. It has significantly contributed to alleviating human suffering and acquiring new knowledge for the prevention and treatment of diseases in animals themselves. To this day, such studies are considered essential in certain contexts, such as scientific research. However, in recent decades, the scientific community has begun to question the use of animals in research, raising concerns about their welfare and the reliability of the results obtained, given the obvious morphological differences between species. These concerns are further compounded by significant ethical and moral issues. In this context, the 3Rs Principle was introduced for the first time in 1957 by Charles Hume and William Russel. Its aim is to reduce, refine, or, ideally, replace the use of animals in experimentation. The introduction of this principle initiated a new perspective in the research world, seeking to increase the development of new methodologies, such as in vitro, in chemico, and in silico techniques, designed to minimize or completely eliminate the need to use animals in experimentation.In the cosmetic field, the need for new alternative approaches to animal testing for safety evaluation, in response to the 3Rs Principle, became particularly important with the implementation of the European Cosmetics Regulation EC 1223/2009. This regulation prohibits the marketing of cosmetic ingredients and finished products tested on animals within the European Union. This thesis will therefore analyze the current directives regulating animal experimentation, with particular focus on the cosmetics industry, concentrating on the limitations of animal testing and the current alternative methodologies used in the toxicological evaluation of substances intended for the formulation of cosmetic products.| File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.14239/28479