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Abstract(s)
As embalagens de produtos cosméticos, exercem um papel primordial, uma vez que
acondicionam o produto, fornecendo proteção contra riscos físicos, biológicos e
químicos, assim como estabilidade durante o seu prazo de validade.
Uma parte significativa das embalagens de produtos cosméticos é constituída por
materiais plásticos, de diversos tipos, que utilizam no seu fabrico aditivos químicos, que
podem apresentar alta toxicidade, hepatotoxicidade e teratogenicidade. Desta forma, a
avaliação das embalagens na indústria cosmética é um requisito fundamental para
garantir a segurança dos produtos para a saúde humana.
O estudo das características do material de embalagem e das possíveis interações dos
diversos ingredientes entre si e com o material da embalagem é determinante, e tem
seguido a regulamentação e normas utilizados para as embalagens de produtos
alimentares ou, em alguns casos os estudos de extraíveis e lixiviáveis utilizados na
indústria farmacêutica.
Deste modo, o objetivo desta dissertação é adequar os estudos efetuados nas embalagens
de plástico em contacto com os produtos alimentares à realidade dos produtos
cosméticos, nomeadamente através de ensaios otimizados e validados para estudos de
migração, extraíveis e de lixiviáveis, adaptando os simuladores utilizados, temperaturas
e tempos de ensaio. Para isso, recorreu-se a três simuladores: etanol 10%, etanol 30%,
ácido acético 3%. Foram ainda efetuados estudos no óleo de sésamo, numa formulação
cosmética preparada e num produto cosmético comercial acondicionado em embalagem
plástica.
Os ensaios de migração global, a 20ºC e 40ºC, foram efetuados por um período de 10
dias e, posteriormente, através da evaporação obteve-se o valor da migração
correspondente. Nos estudos de extraíveis e lixiviáveis, recorreu-se às técnicas de
desadsorção térmica e Micro-Extração em Fase Sólida acoplada à Cromatografia
Gasosa/Espetrometria de Massa.
No ensaio de migração global, os brancos dos simuladores apresentaram valores de
migração global inferiores ao limite de quantificação ou com variações mínimas em
relação às amostras. Os resultados dos simuladores nessas condições foram inferiores a
10 mg/dm², valor é considerada baixo e está dentro de um nível aceitável de segurança.
O ensaio de extração direta térmica realizado na embalagem de plástico utilizada nos
outros testes proporciona insights valiosos. Embora não tenha detetado a presença de muitos compostos orgânicos voláteis e semivoláteis, a capacidade de relacionar os
compostos obtidos com os detetados nos lixiviáveis é significativa.
A identificação do composto orgânico volátil decametilciclopentassiloxano na emulsão
preparada a 20 °C levanta a possibilidade de migração da embalagem para o produto. No
entanto, a presença desse composto também no branco sugere que ele pode ser parte da
formulação.
O objetivo principal foi alcançado ao estabelecer uma base de trabalho para uma
avaliação mais aprofundada das embalagens plásticas na indústria de cosméticos. A
identificação de uma técnica analítica de extraíveis, sem o uso de solventes orgânicos e
com menos manipulação manual durante a execução do ensaio, representa uma
contribuição valiosa para futuros estudos.
A avaliação de segurança deve ser abrangente e considerar potenciais riscos à saúde, bem
como possíveis impactos na qualidade do produto cosmético. Estabelecer esses limites é
uma medida preventiva que contribui para a conformidade regulatória e a proteção dos
consumidores.
Cosmetic product packaging play a crucial role as they surround the product, providing protection against physical, biological, and chemical risks, as well as stability during its shelf life. A significant portion of cosmetic product packaging is made from various types of plastics that incorporate chemical additives in their manufacturing, which can pose high toxicity, hepatotoxicity, and teratogenicity risks. Thus, the assessment of packaging in the cosmetics industry is a fundamental requirement to ensure product safety for human health. The study of packaging material characteristics and possible interactions among various ingredients with both each other and the packaging material is crucial and has followed the regulations and standards used for food product packaging or, in some cases, the extractables and leachables studies used in the pharmaceutical industry. Therefore, the aim of this dissertation is to adapt the studies conducted on plastic packaging in contact with food products to the reality of cosmetic products, specifically through optimized and validated tests for migration, extractables, and leachables studies, by adjusting the simulators used, temperatures, and assay durations. To achieve this, we used three simulators: 10% ethanol, 30% ethanol, 3% acetic acid. Additionally, studies were conducted on sesame oil, in a prepared cosmetic formulation and in a commercial cosmetic product packaged in plastic containers. Global migration tests at 20°C and 40°C were conducted for a period of 10 days, and subsequently, the corresponding migration value was obtained through evaporation. For extractables and leachables studies, thermal desorption techniques and Solid-Phase Micro-Extraction coupled with Gas Chromatography/Mass Spectrometry were employed. No essay on global migration, the simulator blanks exhibited migration values below the quantification limit or minimal variations compared to the samples. The simulator results under these conditions were below 10 mg/dm², a value considered low and within an acceptable safety level. The thermal direct extraction assay performed on the plastic packaging used in other tests provides valuable insights. Although it did not detect the presence of many volatile and semi-volatile organic compounds, the ability to correlate the obtained compounds with those detected in leachables is significant. The identification of the volatile organic compound decamethylcyclopentasiloxane in the emulsion prepared at 20 °C raises the possibility of packaging migration to the product. However, the presence of this compound in the blank also suggests it may be part of the formulation. The main objective was achieved by establishing a working foundation for a more indepth evaluation of plastic packaging in the cosmetics industry. The identification of an analytical technique for extractables, without the use of organic solvents and with less manual handling during the assay execution, represents a valuable contribution to future studies. Safety assessment should be comprehensive, considering potential health risks and possible impacts on the quality of cosmetic products. Setting these limits is a preventive measure that contributes to regulatory compliance and consumer protection.
Cosmetic product packaging play a crucial role as they surround the product, providing protection against physical, biological, and chemical risks, as well as stability during its shelf life. A significant portion of cosmetic product packaging is made from various types of plastics that incorporate chemical additives in their manufacturing, which can pose high toxicity, hepatotoxicity, and teratogenicity risks. Thus, the assessment of packaging in the cosmetics industry is a fundamental requirement to ensure product safety for human health. The study of packaging material characteristics and possible interactions among various ingredients with both each other and the packaging material is crucial and has followed the regulations and standards used for food product packaging or, in some cases, the extractables and leachables studies used in the pharmaceutical industry. Therefore, the aim of this dissertation is to adapt the studies conducted on plastic packaging in contact with food products to the reality of cosmetic products, specifically through optimized and validated tests for migration, extractables, and leachables studies, by adjusting the simulators used, temperatures, and assay durations. To achieve this, we used three simulators: 10% ethanol, 30% ethanol, 3% acetic acid. Additionally, studies were conducted on sesame oil, in a prepared cosmetic formulation and in a commercial cosmetic product packaged in plastic containers. Global migration tests at 20°C and 40°C were conducted for a period of 10 days, and subsequently, the corresponding migration value was obtained through evaporation. For extractables and leachables studies, thermal desorption techniques and Solid-Phase Micro-Extraction coupled with Gas Chromatography/Mass Spectrometry were employed. No essay on global migration, the simulator blanks exhibited migration values below the quantification limit or minimal variations compared to the samples. The simulator results under these conditions were below 10 mg/dm², a value considered low and within an acceptable safety level. The thermal direct extraction assay performed on the plastic packaging used in other tests provides valuable insights. Although it did not detect the presence of many volatile and semi-volatile organic compounds, the ability to correlate the obtained compounds with those detected in leachables is significant. The identification of the volatile organic compound decamethylcyclopentasiloxane in the emulsion prepared at 20 °C raises the possibility of packaging migration to the product. However, the presence of this compound in the blank also suggests it may be part of the formulation. The main objective was achieved by establishing a working foundation for a more indepth evaluation of plastic packaging in the cosmetics industry. The identification of an analytical technique for extractables, without the use of organic solvents and with less manual handling during the assay execution, represents a valuable contribution to future studies. Safety assessment should be comprehensive, considering potential health risks and possible impacts on the quality of cosmetic products. Setting these limits is a preventive measure that contributes to regulatory compliance and consumer protection.
Description
Keywords
Cosméticos Embalagens Plásticas Extraíveis Lixiviáveis Migração