RESUMEN
BACKGROUND: Phthalates are excipients in drug formulations. However, concerns have been raised about the effects of particular phthalates on reproduction and development. As a result the EMA has introduced guidelines for permitted daily exposure (PDE) limits for certain phthalates. Therefore, the objective of this study was to identify UK licensed medicines that contain the relevant phthalates and determine if they fall within the recommended PDE. METHODS: The eMC was used to identify which UK licensed medicines contain the phthalates in question. Companies were then contacted for information on the phthalate levels in their products, which was compared with the PDE recommended by the EMA. RESULTS: The eMC search revealed that 54 medicines contained at least one of the phthalates in question. However, only six medicines, namely Asacol 800 mg MR (Warner Chilcott UK), Epilim 200 Gastro-resistant tablets (Sanofi), Prednisolone 2.5 mg and 5 mg Gastro-resistant tablets (Actavis UK), Vivotif (Crucell Italy S.r.l), and Zentiva 200 mg Gastro-resistant tablets (Winthrop Pharmaceuticals UK), were identified as containing levels that exceeded the recommended PDE. CONCLUSIONS: These findings indicate that very few UK licensed medicines will be affected by the proposed EMA guidelines. For those medicines identified as exceeding recommendations, these findings highlight the need to instigate a risk-benefit review.
Asunto(s)
Dibutil Ftalato/normas , Formas de Dosificación/normas , Excipientes/normas , Adhesión a Directriz , Ácidos Ftálicos/normas , Polivinilos/normas , Humanos , Reino UnidoRESUMEN
Emission test chamber measurement is necessary to proof building materials as sources of volatile organic compounds (VOCs). The results of such measurements are used to evaluate materials and label them according to their potential to emit harmful substances, polluting indoor air. If only labelled materials were installed indoors, this would improve indoor air quality and prevent negative impacts on human health. Because of the complex testing procedure, reference materials for the quality assurance are mandatory. Currently, there is a lack of such materials because most building products show a broad variation of emissions even within one batch. A previous study indicates lacquers, mixed with volatile organic pollutants, as reproducible emission source for a wide range of substances. In the present study, the curing of the lacquer-VOC mixture inside micro-chambers was optimised. Therefore, the humidity and the chamber flow were varied. Typical indoor air pollutants with a wide range of volatilities, for example, styrene, n-hexadecane, dimethyl and dibutyl phthalate were selected. It turned out that, under optimised curing parameters inside the micro-chamber, their emission can be reproduced with variations of less than 10 %. With this, a next important step towards a reference material for emission testing was achieved.
Asunto(s)
Laca/análisis , Compuestos Orgánicos Volátiles/análisis , Compuestos Orgánicos Volátiles/normas , Contaminación del Aire Interior/análisis , Alcanos/análisis , Alcanos/normas , Dibutil Ftalato/análisis , Dibutil Ftalato/normas , Humedad , Ensayo de Materiales , Ácidos Ftálicos/análisis , Ácidos Ftálicos/normas , Control de Calidad , Estándares de Referencia , Reproducibilidad de los Resultados , Estireno/análisis , Estireno/normasRESUMEN
In this paper, the cumulative risks of Di(2-ethylhexyl) phthalate (DEHP), Di-n-butyl phthalate (DBP), and Benzyl-butyl phthalate (BBP) to 2-year-old children in two countries: one European (Denmark) and one Asian (South Korea) were compared. Denmark does not produce phthalates as a raw material, while Korea produces more than 0.4milliontons of the three above-mentioned phthalates each year. First, a comparative review of the existing phthalate regulations in the two countries was performed. Next, the level of childhood phthalate exposure from environmental and food sources was estimated using an exposure scenario approach. Then, the scenario based exposure level was compared with back-calculated exposure levels based on biomonitored urinary phthalate metabolite concentrations. The result verifies the existence of varying territorial human background exposure levels and the gap between exposure estimations based on exposure modeling and biomonitoring data. Cumulative childhood risk levels in Denmark were lower than in Korea. For both countries, risk levels from back calculation were higher than those from scenario estimation. The median cumulative risk levels from scenario estimation and back calculation respectively were 0.24 and up to 0.5 in Denmark while 0.52 and up to 0.95 in Korea. Food and indoor dust were the main exposure sources for all three phthalates. In order to protect human health from cumulative risks of these phthalates, the exposure scenarios in existing regulations such as the EU REACH need to be strengthened. Moreover, based on the contributions from different exposure sources, national specific risk management tools need to be developed and strengthened, applying a systemic approach to promote sustainable material flows.